July 11, 2014

24-Hour Pharmacists Make for a Safer ER for Kids

Medication errors are far too common among hospital patients, but one pediatric hospital is taking measures to reduce them and the sometimes life-threatening harm they can cause.

Making fewer medication mistakes, which, according to a story on NPR.org, contribute to more than 7,000 U.S. deaths every year, is a matter of more professionals remaining on the job for a longer period of time — specifically, hospital pharmacists. In the emergency department at Children's Medical Center in Dallas, pharmacists who specialize in emergency medicine review each prescription to ensure it's the correct one in the correct dose.

Children’s has 10 full-time emergency pharmacists, more than anywhere else in the country, and they’re on call 24 hours a day.

"Every single order I put in," Dr. Rustin Morse told NPR, "is reviewed in real time by a pharmacist in the emergency department prior to dispensing and administering the medication." Rustin is chief quality office and a pediatric ER doc.

That quality-control seems like a no-brainer, but especially in a busy ER, doctors treat fast and move on to the next patient. Writing down the name and quantity of a drug quickly invites mistakes. But in this ER, if that happens, it’s more likely a pharmacist will catch it.

Medication errors, as NPR notes, can be the result of poor handwriting, confusion between drugs with similar names, poor packaging design or confusion between metric or other dosing units. Often, more than one factor is involved.

That’s particularly dangerous for children because medication errors are three times more likely to occur with youngsters than adults. They absorb drugs at a different rate from adults.

So, for the nearly 20,000 drug orders processed at Children’s in a given week, pharmacists review all pertinent information — the child's weight, allergies, medications and health insurance coverage.

The electronic medical record system also automatically checks orders to prevent errors. You need both reviews, because neither human nor machine is infallible.

Dr. James Svenson, associate professor of emergency medicine at the University of Wisconsin, co-authored a study in the Annals of Emergency Medicine that found that even with an electronic medical record, 1 in 4 children's prescriptions had errors; 1 in 10 adult prescriptions also was wrong. So now, there’s a 24-hour ER pharmacist at Svenson’s hospital.

The reason most hospitals don’t embrace this practice is the usual one: money. "If you're in a small ER, it's hard enough just to have adequate staffing for your patients in terms of nursing and techs,” Svenson said, “let alone to have a pharmacist sitting down. If the volume isn't there, it's hard to justify."

But the investment has been proved to work. Researchers for the Journal of Pediatric Pharmacology and Therapeutics showed that prescription review can reduce the number of hospital readmissions. That not only saves money, but also lives.

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July 4, 2014

Warning of Suicide Risk with Antidepressants Had Unintended Consequences

Remember several years ago, when the FDA issued warnings about the risk of suicide for children and adolescents who were taking antidepressants? Well, stand by for an attitude adjustment. A study published last month in BMJ showed that the effort to save children probably harmed them instead.

The researchers tracked an increase in suicide attempts that seem to have been the result of depressed youngsters failing to seek treatment at all. They said the study shows how public health warnings that were intended to do good sometimes can backfire, especially if the subject is sensitive and gets a lot of media attention.

As the Washington Post recalled, the FDA issued warnings in 2003 and 2004 of an increase in suicidal thoughts among some children and adolescents who were taking a certain class of antidepressants (selective serotonin reuptake inhibitors, or SSRIs); you might recognize some of their brand names — Paxil and Zoloft.

So dire was the potential for harm that the FDA required manufacturers of the drugs to include a “black box” warning on the label. Such warnings denote the highest level of concern about side effects, including death. The warnings specified that the drugs presented an increased risk of suicidal thoughts and behaviors in youths who take them.

The media were all over this story, and the study’s researchers said the coverage focused more on the tiny percentage of patients with those thoughts than on the vastly larger number of youths who benefited from antidepressants.

After the warning, antidepressant prescriptions declined sharply among kids 10 to 17 years old, and among young adults from 18 to 29. Coincidentally, the researchers found, the number of suicide attempts rose by more than 1 in 5 among the younger group, and by more than 1 in 3 among the older group.

Of course the media’s lapel-grabbing headlines — “FDA links drugs to being suicidal” (New York Times), and “FDA confirms antidepressants raise children’s suicide risk” (The Washington Post) — “became frightening alarms to clinicians, parents and young people,” the researchers wrote. But consumers bore some responsibility as well.

“There was a sort of overreaction by the media, but also an excessive caution on the part of patients,” Christine Lu, a Harvard Medical School researcher and co-author of the BMJ study, told The Post. “Lots of people who needed treatment steered clear because of the fear factor. … For any drug, there are risks, for sure. But there’s also the risk of leaving the underlying condition untreated.”

Her team plotted the rise in suicide attempts by studying reports of nonfatal poisonings involving psychiatric medicines, which is a common indicator of attempted suicides. They thought the likely number of suicide attempts probably was much higher, because they didn’t track other suicide methods and poisonings that went unreported.

As The Post noted, the BMJ findings dovetail with a 2007 study in the American Journal of Psychiatry that showed a steep decline in antidepressant prescriptions after the feds issued the warnings.

That study didn’t prove that suicides rose as a direct result of fewer such prescriptions, but experts said there weren’t a lot of other explanations.

Despite their conclusion, the BMJ researchers don’t believe that the FDA was wrong in issuing the warning 10 years ago. But “FDA advisories and boxed warnings can be crude and inadequate ways to communicate new and sometimes frightening scientific information to the public,” they wrote.

And the researchers point out that media attention can raise awareness of medical situations people should know about, like the risk of Reye’s syndrome in children who are given aspirin. But, they said, sometimes “the information may be oversimplified and distorted when communicated in the media.”

Not every scientific mind agreed that advisories were too bold. In Discover magazine, an article by The Neuroskeptic titled “The FDA’s Antidepressant Warning Didn’t Really ‘Backfire,” took issue with the study’s conclusions:

“And while the authors never outright state that the FDA’s warning caused the extra suicide attempts,” it said, “they strongly imply that, using phrases such as ‘It is disturbing that after the health advisories, warnings, and media reports [...] we found substantial reductions in antidepressant treatment and simultaneous, small but meaningful increases in suicide attempts.’ “Are they right to be disturbed? By my reading – no. Their data just don’t support a causal effect.”
Neuroskeptic’s argument is interesting and rather geeky, and deserves consideration. The lesson here is that both regulators and the people who watch them must not be alarmists when communicating drug risks. And the lesson for parents with children who are depressed is to discuss frankly and fully the risks and benefits of all treatments. Like all drugs, antidepressants might be exactly what some people need, and not the best option for others.

It’s a matter of the degree of illness and managing its risk.

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May 2, 2014

Is Codeine Overused in Emergency Treatment of Kids?

A couple of years ago, we blogged about crowded emergency departments where children who present with bone fractures are made to wait too long to receive pain medicine.

There’s no excuse for unnecessarily prolonging anyone’s pain, but there’s also danger in giving the wrong painkiller to the wrong person at the wrong time.

According to a new study published in Pediatrics, the powerful opioid codeine is prescribed for children in at least half a million ER visits every year, despite recommendations to limit its use among youngsters.

That’s a big number, but, thankfully, it represents only a small fraction of all pediatric ER visits every year — about 3 in 100. But the researchers still are concerned that too many kids are getting the drug when better options are available.

As noted on Medline Plus, a drug information site from the National Institutes of Health, “Some children who took codeine to relieve pain after surgery to remove their tonsils and/or adenoids have had slowed breathing and have died during their treatment. Many children who have surgery to remove their tonsils and adenoids are being treated for obstructive sleep apnea (condition in which the airway becomes blocked or narrow and breathing stops for short periods during sleep). This condition makes these children especially sensitive to breathing problems. Codeine should not be used to relieve pain in children after surgery to remove the tonsils and/or adenoids. If your child's doctor prescribes codeine to relieve pain after this type of surgery, talk to your doctor about using a different medication to treat the pain.”

Many people might remember when codeine routinely was given as a cough remedy, when cough syrup was available without a prescription, limits on amount purchased or pharmacy screening. People still take it, even though there’s no evidence of its effectiveness for cough relief, and the American Academy of Pediatrics recommends against using it for the purpose, especially in light of the risks.

As summarized in a story by the Associated Press (AP), the concern is that codeine is a drug that some people absorb too quickly, which can cause dangerous side effects, including excessive sleepiness and difficulty breathing. Last year, a “black box warning,” the strictest possible, was issued by the FDA, alerting medical practitioners and consumers about the risk of life-threatening complications or death in children given the drug after the surgeries described above.

The drug, however, might be ineffective for pain relief in for as many as 1 in 3 patients.

The Pediatrics study authors analyzed 10 years of national data on ER visits for kids 3 to 17. Although the number of visits in which codeine was prescribed fell slightly during the study period, the authors estimated that the range of use was between 560,000 and 877,000 times. Unfortunately, information on any side effects was not included in the data.

One pediatric drug expert told AP that it's likely that the use of codeine for kids has diminished since the study ended, thanks mostly to the FDA's black box warning. But another said that some ER doctors might not have been aware of the pediatric guidelines for limiting codeine's use, especially if they recalled getting the drug when they were kids, when its use was more common, and they suffered no ill effects.

A physician a spokesman for the American College of Emergency Physicians said that codeine could be used safely for many children, especially older kids.

If your doctor suggests using codeine to alleviate you child’s cough, ask about alternatives, such as dark honey (only if the child is older than 1 — honey is dangerous for babies). If it’s suggested to relieve pain for injuries such as broken bones, ask about ibuprofen or hydrocodone instead.

If you and the ER doctor determine that the benefit of codeine outweighs the risk, make sure the staff monitors the child after he or she takes the drug. If there is no ill effect, and you’re given a prescription to fill later, make sure the medicine worked in the ER to relieve the pain — you don’t want to court danger by taking a risky medicine that doesn’t even work for a lot of people.

If your child takes codeine and develops breathing problems or unusual sleepiness, seek medical attention immediately.

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April 4, 2014

C. Diff Infections in Kids Linked to Overuse of Antibiotics

Antibiotics can be lifesavers. And they can be life-threatening.

The dangers of overprescribing and overusing antibiotics are well known (see our blog, “CDC Report on Antibiotic Resistance Sounds Ominous Note.”), and now there are disturbing new signals that they can pose a dire threat to children.

According to a report in Pediatrics, most Clostridium difficile (C. diff) infections in children might be linked to antibiotics prescribed by doctors.

Considered a “super bug” — that is, an unusually strong and difficult to eradicate microbe — C. diff is a bacteria that causes intestinal infections and severe diarrhea. It’s painful and can be deadly. More than 17,000 children in the U.S. contract C. diff infections each year.

The Pediatrics study showed that antibiotic use was associated with nearly 3 in 4 C. diff infections, even though the drugs weren't taken because of C. diff.

As summarized on AboutLawsuits.com, researchers analyzed data from C. diff cases of nearly 1,000 children between 1 and 17 years old. They were from 10 different U.S. regions.

More than 7 in 10 cases involved bouts of diarrhea. In more than 7 in 10 of those cases, doctors had prescribed antibiotics to treat other conditions within the previous 12 weeks. The subjects had not tested positive for C. diff within the previous eight weeks. No deaths were linked to the C. diff cases.

The highest incidence of infection was found among white children between 1 and 2 years old.

The study was not conclusive about the cause of the infections, but it did demonstrate a strong association between the C. diff and antibiotic use.

Most of the children in this study had taken antibiotics for ear, sinus or upper respiratory infections. Half of all antibiotics prescribed to children for respiratory infections are not required, noted AboutLawsuits.com. Because antibiotics also destroy beneficial bacterial that can protect against infections, taking them unadvisedly — for a viral infection (the drugs address only bacteria, not viruses) or for a problem that, given time, rest and other less aggressive measures, will resolve on its own — invites a larger threat.

The story refers to a study last year that found that doctors prescribed antibiotics in 6 of 10 cases of sore throat; only 1 in 10 cases can be treated effectively with them.

So although parents are desperate to address their child’s pain, discomfort and fever, they shouldn’t routinely ask for an antibiotic prescription for most common childhood infections. And the new study shows that the danger might be even worse than we thought.

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March 7, 2014

Taking Tylenol During Pregnancy Might Elevate Risk of Child with ADHD

As if it weren’t difficult enough to follow all the rules for improving the chances of both a safe pregnancy and a healthy baby, now there’s evidence that pregnant women who take acetaminophen (Tylenol and many other brands) to relieve pain or reduce fever might be raising the risk of bearing a child later diagnosed with attention deficit hyperactivity disorder (ADHD).

A study published in JAMA Pediatrics showed a 40% higher chance of such a diagnosis for children whose mothers took acetaminophen during pregnancy versus those who didn’t.

As explained by the Los Angeles Times, the study doesn’t establish that prenatal exposure to acetaminophen caused the observed increase in diagnosed hyperactivity disorders, prescriptions for ADHD medications or emotional problems in children reported by parents. But the study was designed to address shortcomings of other studies that find an association between an environmental exposure and the appearance of a specific outcome years later.

More than 64,000 Danish mothers and their children were study subjects. Information was collected about pregnant subjects’ acetaminophen use long before problems in their children’s learning or behavior would have become evident. That enabled researchers to avoid what’s called “recall bias” — you can’t pre-judge something you don’t know will happen.

Pediatric subjects were studied from their first trimester in utero for as long as 15 years. In addition to surveying parents about their children’s strengths and weaknesses, the researchers used comprehensive, reliable databases (registries of physician diagnoses and dispensed pharmacy prescriptions) to measure ADHD within the population.

The study concluded that the probability of a child developing ADHD symptoms severe enough to require medication jumped by more than 60% if his or her mother took acetaminophen during the last two trimesters of pregnancy; it rose by almost 30% if acetaminophen was taken only in the third trimester. If mom took the drug during only the first trimester, the increased risk was about 9%.

Because a pregnant woman’s high fever and infection can be dangerous for her fetus, an editorial accompanying the study advised that women and their doctors shouldn’t reject acetaminophen solely based on this study. It said that more information is needed on how acetaminophen might promote ADHD later, when and who is most likely to be affected. The current findings, it advised, “should be interpreted cautiously and should not change practice.”

So what’s a prospective mother to do?

Even medicine deemed safe carries risks, and doubly so for pregnant women. The safest approach is to take the lowest possible dose as seldom as possible, said Dr. Daniel Kahn, a maternal-fetal health specialist interviewed by The Times. He was not involved in the study.

If it doesn’t work, you have to discuss options with your doctor. Kahn added that the study “certainly wouldn’t stop me from treating a fever,” noting that unchecked fevers have been associated with several poor health outcomes in babies, including lowered IQs.

Acetaminophen has gotten some bad publicity of late, largely due to confusing dosing. To understand how to make the most of this medicine without undue risk, see our blog, “Understanding Acetaminophen and How to Make It Safer.”

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January 31, 2014

Making Liquid Medicine Less Likely to Harm Kids

We’ve written frequently about how difficult it can be to give children proper dosages of medicine — “How Big Pharma and the Fed Caused Infant Death Over Confusing Acetaminophen Dosages” and “Cold Medicines Are Dangerous for Very Young Children,” for example. ProPublica.org, the investigative news site, recently discussed how a certain safety device on medicine for kids could prevent drug accidents and overdoses.

Now, as reported by that outfit, New York Sen. Charles E. Schumer is urging the FDA and the Consumer Product Safety Commission (CPSC) to require drug makers to install flow restrictors in all liquid children’s medication within a year.

“If they don’t do it on their own, I will seriously consider legislation,” he said at a news conference last week.

Flow restrictors, as described by ProPublica, are small, plastic valves inserted into the necks of bottles of liquid medicine to slow the release of medication. That makes it more difficult for children to swallow a harmful amount. Approximately 10,000 children are seen every year in emergency rooms for potential medication overdoses, according to the Centers for Disease Control and Prevention (CDC). Some are hospitalized, and about 20 kids die from overdoses.

In 2011, drug makers voluntarily placed flow restrictors in bottles of infant’s acetaminophen, the active ingredient in Tylenol. Many also put them in children’s acetaminophen products.

But acetaminophen, says ProPublica, is involved in only about 1 in 4 of those emergency room visits. Other common over-the-counter medicines, including ibuprofen, cough and cold formulations and antihistamines, account for most of the rest.

Although industry trade groups say they are studying ways to minimize these accidents, federal regulators haven’t exactly been aggressive in making the industry do more. For one thing, FDA officials hold differing opinions about whether they have the power to mandate the devices.

Last year, the CPSC promoted the establishment of a voluntary set of standards for flow restrictors, working with a nongovernmental organization composed of industry representatives, federal officials and independent researchers.

The companies that make acetaminophen products have installed flow restrictors of varying efficacy, according to ProPublica. Different models were tested, and so-called “closed” restrictors — resealing rubber coverings that must be punctured by a syringe — worked better than “open” designs, typically plastic discs with small holes at their centers. But of the 31 bottles tested, only five had closed restrictors.

Schumer wants all the meds to have the closed restrictors. In his news conference, he said, “The closed restrictor, the foolproof kind, is 8 to 10 cents a bottle. You’re paying five, six, seven dollars, even more for this medication, so another dime to keep your kids safe is a choice that just about every parent would make.”

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December 6, 2013

Changing Cold Medicine Labels Saves Kids; Changing Habits Does Too

A few years ago, manufacturers of children’s cough and cold medicines revised their labels because the dosages were confusing and unsafe. (See our blog “Cold Medicines Are Dangerous for Very Young Children.”) The labels were changed to direct parents not to give these meds to kids younger than 4.

Last month, the New York Times reported, the effort to revise label information has resulted in a significant decrease in emergency hospital visits by toddlers and infants with problems suspected to be the result of taking these meds.

A study published in the journal Pediatrics reviewed data from 63 hospitals to estimate the number of emergency visits from 2004 to 2011 by young children who had taken cough and cold medicines.

Children younger than 2 accounted for 4 in 100 emergency visits for suspected drug-related effects before the measures were taken in 2007, but accounted for slightly more than 2 in 100 afterward. Among 2- to 3-year-olds, ER visits associated with cough and cold medicines dropped from 9 ½ in 100 to 6 ½ in 100.

But there was no significant reduction in emergency visits among children 4 to 11 — their numbers dropped from 6 ½ in 100 to about 5 ½ in 100.

The report could fuel debate about when it is safe for children to be given cough and cold medicines. Dr. Matthew M. Davis, professor of pediatrics and public policy at the University of Michigan told The Times, “I would call this Chapter 1 in the story. Chapter 2 is going to require additional changes in policy to reduce adverse drug events for older children, 4 and older, and to ensure safer medications in the home medicine cabinet for all ages.”

Dr. Daniel Frattarelli, a former chairman of the committee on drugs at the American Academy of Pediatrics, wants “do not use” labeling for children 6 and younger. “The label doesn’t reflect the current evidence that these medications are ineffective for treating cough and cold symptoms in kids under 6,” he told The Times.

The FDA has been reviewing the safety and efficacy of over-the-counter cough and cold medicines in children for several years. No one was able to tell The Times when the work would be complete.

The new study found that most babies and toddlers in the ER survey with problems thought to be related to these medicines consumed them when parents didn’t see them. To a 2-year-old, a cold pill can look like candy.

One pediatrician told The Times of a 3-year-old patient who drank cough medicine that her 10-year-old sister had left on a bathroom shelf with the cap secure. The toddler experienced an elevated heart rate, agitation, then became drowsy. Showing signs of an overdose, the kid ended up in an emergency department.

The pediatrician said that although she understands why parents use cough and cold drugs, she found it “astonishing” that emergency room resources were still squandered on “products that are not proven to work and have been repeatedly implicated in adverse events.”

This year, according to the poll referenced in our blog above, 4 in 10 parents reported giving cough medicine or multi-symptom cough and cold medicine to children under 4. That’s just not a good idea.

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October 18, 2013

Doctors Are Prescribing Fewer Psychotropic Drugs

A few years ago, we blogged about the high, atypical use of antipsychotic medicine for children, and the disturbing questions such practices sparked about such widespread use of these powerful drugs. We also wrote about how the boom in diagnoses for attention deficit hyperactivity disorder (ADHD) can lead to overmedicating.

A recent study published the journal Pediatrics, however, shows that by the end of 2009, psychiatric medications were used less often for young children.

Psychotropic drugs, which affect one’s mental state and often his or her cognitive abilities, are powerful meds that can be life-saving for some people. But, like all drugs, they carry risks as well as benefits. Children, whose brains are still developing, could be particularly vulnerable to psychotropic side effects.

We’ve written, for example, about the risk of suicide for some drugs that treat attention deficit hyperactivity disorder (ADHD). And in 2004, the FDA issued a warning about the association between antidepressant use among children and suicide risk.

More recently, an association between diabetes and the use of antipsychotics by children has been shown.

So the fact that the percentage of children who are prescribed antipsychotics, stimulants and antidepressants during doctor visits is lower than it was in the mid-2000s is good news.

Dr. Tanya Froehlich, the study’s senior author, told Reuters.com, "I'm very excited that the use of these drugs in this age group seems to be stabilizing.

"It's good to get a gauge on what we're doing with psychotropic medications in this age group, because we really don't know what these medications do to the developing brain."

Earlier studies looked at the use of psychotropic drugs among preschoolers, but they usually focused on one class of medication or only one segment of the population. For this study, national data for about 43,500 doctors' visits from 1994 to 2009 was used, involving kids ages 2 to 5.

In that time span, Reuters explained, the proportion of psychotropic drug prescriptions varied between one prescription for every 217 doctors' visits in 1998 and one for every 54 visits in 2004.

Between 1994 and 1997, about 1% of preschoolers left the doctor’s office with a psychotropic prescription. Between 1998 and 2001, the percentage declined to about 0.8%. It rose to a high of about 1.5% between 2002 and 2005, and dropped to 1% between 2006 and 2009.

Although the latest figure wasn’t the lowest, it was still notable because the decrease and stabilization occurred while increasing numbers of children were diagnosed with behavioral disorders. More diagnoses, but less treatment with heavy drugs.

The study didn’t explain the lowest rate between 2006 and 2009, but the researchers suggested it might be because of a greater awareness of the meds’ possible side effects.

The drugs have been widely prescribed to address disruptive behavior by preschoolers, so perhaps other behavioral interventions are being tried first, and with at least some success.

"The thing pediatricians should be asking themselves is, ‘Are we really following the guidelines in treating these children?' which is trying behavioral therapy and then going to the medications," Froehlich told Reuters.

See our blog, “Does Your Kid Really Need a Psychotropic Drug,” if you think your doctor might prescribe one to address your child’s behavioral issue. Learn more about these medicines on the National Institutes of Health site, Mental Health Medications.

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September 27, 2013

How Big Pharma and the Feds Caused Infant Deaths Over Confusing Acetaminophen Dosages

For 15 years, McNeil Consumer Healthcare, a division of Johnson & Johnson, had sold two versions of Tylenol for young children even though the company knew that parents and doctors were confusing the two. They knew that confusion could have serious, even deadly, results. The FDA ignored the problem.

We’ve addressed the problem with dosing with acetaminophen, the active ingredient in Tylenol, and now a shocking story by the investigative news site ProPublica.org probes even deeper into the confusion over the two types of pediatric Tylenol, and why that’s so dangerous. Remarkably, the story says, “Drop for drop, the strength of Infants’ Tylenol far exceeded that of Children’s Tylenol.

“In addition, the active ingredient in Tylenol, acetaminophen, has what the FDA deems a narrow margin of safety. The drug is generally safe at recommended doses, but the difference between the dose that helps and the dose that can cause serious harm is one of the smallest for any over-the-counter drug.”

Other manufacturers’ products compounded the problem by also offering two children’s products with different concentrations of acetaminophen. Between 2000 and 2009, 20 reports of children who died from acetaminophen toxicity were filed with the FDA, which acknowledged that the figure probably “significantly underestimates” the true incidence.

Between 2001 and 2010, according to the American Association of Poison Control Centers, about twice as many deaths each year were associated with acetaminophen than with all other over-the-counter pain relievers combined, according to data from. Tens of thousands more are hospitalized for overdoses.

ProPublica tells the heartbreaking stories of babies who suffered unnecessarily. To see how the intersection of federal regulatory sloth and pharmaceutical company misbehavior conspired to harm and sometimes kill people seeking only to relieve pain, see our blog, “Acetaminophen Continues to Rack Up Casualties and Escape Regulatory Control.”

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September 20, 2013

Feds Try Harder to Make Manufacturers Test Drugs for Use by Children

Children are not miniature adults, and drugs intended to be consumed by adults aren’t necessarily good medicine for kids. A blog post on the FDA Voice website explains why.

Lynne Yao, associate director, Pediatric and Maternal Health Staff in the FDA’s Center for Drug Evaluation and Research, reminds readers that some drugs work differently according to where in the human maturation the person taking them is. Efficacy is one issue for children taking drugs intended for adults, and safety is another. “That’s why products that are used in children,” Yao says, “must be studied in children."

Two recently reauthorized laws promote that effort. The carrot is the Best Pharmaceuticals for Children Act (BPCA), which offers drug companies six months more of marketing exclusivity if they conduct FDA-requested pediatric studies. The stick is the Pediatric Research Equity Act (PREA), which requires some drugs developed for adults to be studied in children. The studies must be conducted with the same drug and for the same use for which they were approved in adults.

As Yao notes, before BPCA and PREA became law, more than 8 in 10 drugs approved for adult use were being used in children, even though their safety and effectiveness had not been established in children. Today, it’s about 5 in 10. And now that both acts have been reauthorized with additional FDA powers, the hope is that the disparity will shrink farther.

Under PREA, FDA may waive studies in children if they aren’t necessary, such as a drug prescribed for a disease only adults contract, like prostate cancer.

When Congress reauthorized PREA last year as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), it gave the FDA additional authority. The agency may grant extensions for deferred pediatric studies at a sponsor’s request if there is good cause; say, the manufacturer has tried but failed (so far) to recruit a sufficient number of pediatric patients to complete the study.

Sometimes the FDA allowed a deferral and still the deadline was missed, so now, if a sponsor fails to seek or obtain a deferral extension, fails to submit deferred pediatric studies by the final due date agreed to with FDA or fails to request approval for a required pediatric formulation, the FDA will send a noncompliance letter to the company and publish it on the web.

The first such “we warned you” noncompliance letters were published last month, along with the manufacturers’ responses. You can track this show-and-tell at the FDA’s public page here. Among the early letters and responses are those concerning an intravenous form of Protonix, a drug to reduce gastric acid made by Pfizer, and Renvela, taken by people with chronic kidney disease, made by Sanofi.

Other drugs on the tardy-testing list include allergy, anaphylaxis and blood pressure medications, all of which are prescribed for children.

As noted on AboutLawsuits.com, however, it’s unclear whether these laws and the transparency of noncompliance give the FDA enough muscle to compel compliance.

The letters state that the companies failed to satisfy their obligations to conduct pediatric studies on approved children’s medications, but as AboutLawsuits points out, the FDA may label a drug misbranded only if the studies are not conducted. It may not withdraw approval. It’s unclear if the agency can levy fines or take any other punitive actions beyond the public scolding.

Some of the drugs on the letter list were supposed to have been tested on children as long as seven years ago. In each case, AboutLawsuits says, the companies failed to apply for an extension. Although the letters give the companies 45 days to respond, they are silent about any consequences or what happens next.

The FDA’s renewed interest in the safety of pediatric drugs follows recent studies depicting how some medications used on adults have detrimental effects in children.

For example, a study published last month in JAMA Psychiatry found that children who use antipsychotic medications such as Risperdal and Zyprexa had three times the risk of developing type 2 diabetes during the first year of use. That study was the result of a government investigation into the increasing number of children who were prescribed antipsychotic medications intended for adults.

If your child is prescribed a medication, ask the doctor if it has been tested in that form and in that dose for children. If not, or if he or she doesn’t know, consult Medline Plus, the government’s drug information clearing house, and the manufacturer’s website.

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August 16, 2013

Anesthesia Drug May Cause Brain Damage in Kids Undergoing Surgery

Drugs that fall under the category of “anesthesia” are powerful in their ability to separate you from the sensation of pain, and when you’re on the operating room table you wouldn’t want it any other way. But a recent study suggests that for youngsters, at least one of these drugs can have ominous effects.

As reported by AboutLawsuits.com, the drug ketamine can have a toxic effect on developing neurons that can cause learning and memory disorders as well as behavioral problems.

The association was described in a study published in the journal Neural Regeneration Research. It found that children younger than 3 who underwent surgery for an extended period or repeatedly got ketamine for multiple surgeries, exhibited learning and memory disorders and behavioral abnormalities when they reached school age.

The research, which was conducted on rats, not kids, found signs of neural toxicity and neuron death caused by the drug. In case there’s any doubt of ketamine’s power, it has been implicated as a “date rape” drug that leaves victims unable to move or remember what happened. It’s in the same class of drugs as PCP (phencyclidine), a dangerous “recreational” drug, and propofol, the drug that killed Michael Jackson.

Ketamine is a common anesthetic used in combination with a sedative. Apart from pediatric uses, it’s also common in veterinary medicine. Short term side effects sometimes include hallucinations and elevated blood pressure.

The Neural Regeneration Research scientists replicated results found in other studies. They expressed concern that ketamine might cause long-term neurological damage in children, prompting disabled learning and memory function. Dyslexia, hyperactivity and attention deficit hyperactivity disorder (ADHD) were mentioned specifically.

“Researchers,” said AboutLawsuits, “urge health-care providers and parents to weigh the risks with the benefits when considering using ketamine during surgery.”

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August 5, 2013

Early Use of Antibiotics May Lead to Eczema Later

Antibiotics are often necessary to treat an infection, but kids who take them before they’re a year old appear to be more likely to develop eczema.

A report published in the British Journal of Dermatology resulted from a review of earlier research. It concluded that children who took antibiotics in their first year were about 40% more likely to develop the itchy skin disorder. As interpreted in a story by Reuters, the study supports the idea that antibiotics destroy intestinal microbes that contribute to the development of the immune system after birth.

Fetuses exposed to antibiotics taken by their pregnant mothers, however, were not at higher risk of getting eczema after birth.

The Dermatology report, the first to consolidate available results from several studies indicating that early-life exposure to antibiotics increases the risk of eczema, reinforces what’s known as the “hygiene hypothesis”—that babies and youngsters who are not exposed to a wide variety of microbes don’t develop immune systems as robust as those who are. The theory has been applied to immune overreactions such as allergies and asthma.

As we wrote a few months ago, the American Academy of Pediatrics issued new guidelines for diagnosing and treating children’s ear infections in an effort to reduce the unnecessary use of antibiotics because, in addition to helping bacteria develop resistance to the drugs, using antibiotics when they’re not necessary can cause stomach problems and allergic reactions.

For some infections, most kids improve within a couple of days without drug intervention.

As many as 2 in 10 kids will have symptoms of eczema; more than half of them continue to have symptoms into adulthood.

The new report analyzed results of 20 studies of antibiotic use, either prenatally or in the first year of life, and their association with later skin problems. The more antibiotics a baby took, the higher the risk. Each round of antibiotics bumped up the risk of eczema by 7%. Broad-spectrum antibiotics, or those that treat a wide variety of infections, like amoxicillin, seemed to have the strongest effect.

Some experts noted the possibility of "reverse causation”—that’s when a baby with eczema has more skin infections that might require antibiotics and confound the results of the studies. But the authors of the new review acknowledged that limitation and said the findings are still valid.

Another possible flaw in the review concerns when eczema symptoms began and when antibiotics were first administered. The onset of eczema often occurs before a baby is a year old, so if symptoms began before antibiotics were given, those children should have been excluded from the studies.

But even outside experts who pointed out that flaw agreed: Antibiotics should be given to anybody only when it’s necessary, and especially for wee ones whose immune systems are developing.

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May 3, 2013

Cold Medicines Are Dangerous for Very Young Children

All parents of children old enough to spend time around other children know that their offspring are little cold factories. Data from the University of Michigan’s C.S. Mott Children’s Hospital indicate that kids get 5 to 10 colds a year.

To relieve their symptoms, their parents often give wee ones over-the-counter (OTC) cough and cold products. In many cases, that’s bad medicine.

According to a national poll on children’s health by the Mott Children’s Hospital, more than 4 in 10 parents give their children younger than 4 cough medicine or multi-symptom cough and cold medicine. One in 4 gives them decongestants.

In 2008, the FDA issued an advisory that these OTC meds should not be given to infants and children younger than 2. Not only are they not proved to be effective for young children, they can cause serious side effects that might include:


  • convulsions

  • allergic reactions

  • elevated or uneven heart rate

  • drowsiness or sleeplessness

  • slow and shallow breathing

  • confusion or hallucinations

  • nausea and constipation.


A couple of years ago, we wrote about the dangers of Tylenol and dosing information for children younger than 2.

After the FDA warning, manufacturers of OTC cough and cold products rewrote their labels to read that the medicines should not be given to children younger than 4.

Although parents might feel as though they should give their ailing children something, anything, these products “don’t reduce the time the infection will last and misuse could lead to serious harm,” said Dr. Matthew M. Davis, director of the poll, in a University of Michigan news release.

“What can be confusing,” Davis said, “is that often these products are labeled prominently as ‘children’s’ medications. The details are often on the back of the box, in small print. That’s where parents and caregivers can find instructions that they should not be used in children under 4 years old. … [W]hat’s good for adults is not always good for children.”

As with any medication, prescription or OTC, you should always read the labels and patient information that comes with it. Contact your doctor if you’re uncertain about how, or to whom, it should be given.

To learn more about the difficulty in adjusting adult medicine for pediatric use, see our blog, “Drug Labels Still Leave Pediatricians Playing a Guessing Game.”

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November 2, 2012

Off-Label Drugs Commonly Given to Intensive Care Patients

At the American Academy of Pediatrics conference last month, a researcher presented a paper that should give pause to anyone receiving or delivering treatment in a pediatric intensive care unit (PICU).

Susan Sorenson, who holds a doctorate in pharmacy, studied the use of 335 different drugs used in a PICU over a five-month period and found that 3 out of 4 were prescribed “off-label” at least once. “Off-label” is the practice of prescribing a drug for a condition or demographic other than the one for which it received FDA approval. Doctors have the right to so prescribe, and it’s often appropriate to do so, but the drug manufacturer may not promote a drug for any use other than what the FDA granted.

But as described in a report on MedPage Today, what appears to be a routine practice exposes patients to medications that may not have been adequately studied in children. Even if some compounds are suitable for pediatric use, if they haven’t been studied for that population it can be difficult to determine the proper dose and know the possible side effects and risks.

The study has not been published in a peer-reviewed journal, so it should be considered preliminary. The study group was limited to a single, 32-bed facility in Salt Lake where nearly all the patients (96 percent) were given a drug off-label at least once.

Drugs were considered to have been used off-label when prescribed for patients whose ages were not listed on the label, when no pharmacokinetic data (how drugs behave in the body over a period of time) were listed for the patient's age or when they were used for a disorder not approved by the FDA. The study involved 490 patients with ages ranging from 4 days to 17 years.

The most common medications prescribed off-label were morphine, ondansetron (Zofran, for the nausea and vomiting caused by chemotherapy and radiation treatments ), metoclopramide (Reglan, for heartburn and esophageal problems associated with gastroesophageal reflux disease), dopamine (for a wide variety of problems including shock, low blood pressure/heart attack, trauma and infections) and fentanyl (for breakthrough pain from cancer; that is, sudden pain that occurs despite other, ongoing analgesic treatment).

Recent legislation, including the the FDA Modernization Act (FDAMA) and the Best Pharmaceuticals for Children Act (BPCA), has addressed the issue of improved labeling for pediatric drugs. But, Sorenson told MedPage Today, “There’s still some work to do.”

We’ve written about the difficulty in researching and labeling drugs for pediatric applications and the fact that not even half of drug labels carry child-specific information.

Since passage of the BPCA in 2002, only 14 of 40 drugs with the highest number of off-label medication orders during the study have had labeling changes; 19 still lack safety and efficacy information for a pediatric population.

That seems like a roadmap of where to go next, but as Sorenson said, most of the drugs used in the study are off-patent, so it will be difficult to find funding to perform such expensive studies. If manufacturers cannot monetize new or additional research, they’re not motivated to conduct it.

There is some legislative relief: The BPCA extends patent protection for six months if a drug manufacturer agrees to perform pediatric studies. That can be added to the six months of market exclusivity granted by the FDAMA for performing studies in children.

If your child is in the PICU, closely monitor whatever drugs the doctors prescribe. Ask what they are, why they are being given, what is their intended effect and if they have been tested specifically for children or if they are being prescribed off-label. If the latter, ask if there are alternative therapies. And always ask what are the potential side effects and harms.

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July 20, 2012

Antibiotics and ADHD Drug Use in Kids

A recent study conducted by the FDA presented a good-news/huh?-news scenario about what drugs are given to children. As reported by Reuters Health, in the last decade, the number of drugs prescribed for minors in the U.S. has declined. That contrasts with the increase in drugs prescribed for adults.

Although antibiotics use fell significantly, the use of drugs to treat attention deficit hyperactivity disorder (ADHD) rose. The good news relates to antibiotics, whose decline, one hopes, indicates an increasing awareness that these drugs are regularly overused, a practice that encourages the growth of drug resistant microbes.

The huh? news concerns ADHD. The stimulants prescribed to treat it, such as Ritalin (methylphenidate), lead the pack for children’s drug use. From 2002 to 2010, the use of these meds grew by nearly half, which adds up to about 800,000 prescriptions per year. More than 4 million Ritalin prescriptions were filled in 2010.

One professional camp sees this growth as positive. Dr. Scott Benson, a child and adolescent psychiatrist and spokesman for the American Psychiatric Association, told Reuters that the study results suggest “reduction in the stigma. It used to be, ‘You're a bad parent if you can't get your child to behave, and you're a doubly bad parent if you put them on medicine.'"

But Dr. Lawrence Diller, a behavioral pediatrician, saw things differently. Pointing out that the U.S. is the clear world leader in the use of these drugs, he said, “You have to look at how our society handles school children's problems. It's clear that we rely much, much more on a pharmacological answer than other societies do. The medicine is overprescribed primarily, but under-prescribed for certain inner-city groups of children."

As we reported a few years ago, there have been questions about ADHD drugs for a long time, and the medical establishment’s prescribing habits for them.

The new study showed that, overall, 263 million prescriptions for minors were filled in 2010, down by 7 percent since 2002. Adult prescriptions in the same period increased by 11 percent. In addition to the decline in antibiotic prescriptions for children, there were notable decreases in prescriptions for allergy medicines, cough and cold drugs, painkillers and antidepressants. In addition to ADHD drugs, other increases were tallied for asthma medicine and birth control pills.

As Reuters noted, the FDA couldn’t explain the reasons behind the changes.

A new resource for parents interested in ADHD research and treatment options is available here from the U.S. Department of Health and Human Services.

As always, when your doctor prescribes a drug for your child, ask:


  • Why is this drug being prescribed?

  • What are the potential side effects and risks?

  • How long should it take to see results?

  • What do you expect to happen if the child does not take the drug?

  • Are there alternative treatments?

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June 21, 2012

Teething Products Can Be a Mouthful of Danger

It seems simple: A teething baby cries and a parent rubs the baby's gums with an analgesic to relieve the pain. But a recent FDA statement warns that this can lead to a serious disorder.

Methemoglobinemia, as described in a story on MedPage Today, can lead to oxygen deprivation and even death. Benzocaine, which is found in many over-the-counter products to relieve the pain of teething and toothache, is the source of concern. The greatest risk is for children younger than 2, who are also those most likely to get teething pain.

Methemoglobinemia is also known as “blue baby syndrome.”

This is not the first time the federal agency has warned about products containing benzocaine. In 2006 it issued a warning about such products, which include Baby Orajel, Orabase, Orajel, Anbesol and Huricaine. Since then, it has received 29 reports of benzocaine gel-related cases of methemoglobinemia. Nineteen of them were among children, 15 of whom were younger than 2.

A second warning was issued last year, and we wrote about it then. Given the dire nature of the disorder, the warning bears repeating.

FDA officials are concerned that parents might not be aware of the symptoms of methemoglobinemia. They include:


  • pale, gray, or blue-colored skin, lips and nail beds;

  • shortness of breath;

  • fatigue;

  • confusion;

  • headache;

  • light-headedness;

  • rapid heart rate.


Symptoms can occur shortly after use, or maybe not for several hours. A child can experience symptoms after the first use or not for several subsequent uses.

Parents have options for teething pain relief. The American Academy of Pediatrics (AAP) suggests a chilled teething ring or gum massage using your finger. If those don’t work, consult your pediatrician before using a topical agent.

Benzocaine is also used by physicians and dentists to numb parts of the mouth and throat before performing procedures such as transesophageal echocardiograms (in which an ultrasound probe the size of a small finger is inserted into the esophagus to view the heart), endoscopy (in which a scope is used to view the interior of a hollow body organ, such as the stomach) and feeding tube insertions.

If you are or a loved one is scheduled for any of these procedures, discuss the risk with your health-care provider.

Anyone can be at risk from benzocaine; the risk is higher for people with heart disease, asthma, bronchitis or emphysema, and for anyone who smokes.

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February 19, 2012

Cancer Drug's Short Supply Moves to Critical Stage

After it failed an inspection in November by the FDA, Ben Venue Laboratories in Ohio was shut down. No one in his or her right mind would want to take drugs manufactured in a place where mold was growing on the walls and machinery rust was falling into vials.

Now, the toll of the lab’s decrepit state might have to be paid by children with acute lymphoblastic leukemia (ALL) and a type of bone cancer, osteogenic sarcoma. They rely on a longtime cancer drug, methotrexate, that, as NPR reported, can mean the difference between death and cure.

Ben Venue was a principal supplier of injectable methotrexate. Now, its shortage is acute, the latest in long line of critical drug shortages. We’ve written often on the topic, and what is being done to address it.

According to NPR, hospitals throughout the country are “perilously close” to exhausting their supplies of the kind of methotrexate that treats ALL and osteogenic sarcoma. In a few weeks, substituting or delaying therapy might be forced on some patients. Their doctors aren’t certain how that will affect their chances of a cure, which are 9 in 10 with the right treatment.

One expert on drug shortages told NPR that most people don’t realize how many U.S. drug plants are in extreme disrepair, especially those that manufacture generic drugs. Ben Venue claims to have invested $250 million recently to upgrade its facilities, but it’s unclear when it will reopen. That lab also was the sole manufacturer of Doxil, an ovarian and breast cancer drug that’s now unavailable.

But there’s cause for hope. The FDA said the methotrexate and Doxil crises soon may be over. Three other manufacturers are increasing production of the specific kind of methotrexate at issue, and they told the feds that additional supplies should be available within weeks.

The FDA is considering licensing a foreign company to make Doxil, a measure it has taken eight times in the last year to address other drugs in critical shortage.

And last week Ben Venue posted a message on its website that it was working with the FDA to expedite the availability of methotrexate and immediately would begin releasing a limited supply to oncology clinics, hospitals and pediatric facilities. "We hope this supply will help address near-term patient needs while other companies licensed to manufacture methotrexate increase production," the statement read.

Doctors were optimistic about restocking hospital supplies of methotrexate, but, as one told NPR, “[T]his is not the last shortage we’ll have to cope with.”

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February 13, 2012

Panel Recommends Suicide Warning Be Added to ADHD Drug Label

A panel of pediatric experts has recommended that the FDA change the label for Focalin to address the risk of suicidal thoughts by children, according to Reuters.

The drug is prescribed for attention deficit disorder and is manufactured by Novartis AG. It was approved for children 6 and older in 2001.

Children with ADHD are excessively restless, impulsive, easily distracted and often have behavioral issues. Symptoms generally are relieved with behavioral therapy and medication (at least short term; the long term benefits of medication are less clear).

The FDA is not required to follow the advice of its panels, but usually does. It is required to hold regular advisory meetings to review the safety of drugs used by children. The panel also recommended that Focalin's label acknowledge the risk of anaphylaxis, an allergic reaction, and angioedema, a type of swelling beneath the skin.

The current label for Focalin advises patients about psychotic or manic side effects, but does not mention suicidal thoughts.

The FDA received eight reports of suicidal thoughts by children or adolescents who took the drug over the last six years. This risk did not present during the clinical trials of the drug, and the number of such reports is tiny in comparison to the number of patients taking it. If your child is taking Focalin, he or she shouldn’t stop taking it. But do consult your pediatrician.

Diagnoses of ADHD (attention deficit hyperactivity disorder) have boomed in recent years; an estimated 3 to 5 kids in 100 are affected. Some experts question whether these diagnoses are made too quickly and drugs prescribed too easily. We’ve addressed the suitability of prescription drugs for ADHD.

According to Reuters, approximately 2.7 million people in the U.S. have prescriptions for ADHD drugs. Approximately 1.8 children received prescriptions for Focalin or its generic versions from 2005 to 2011.

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September 12, 2011

Do Hospitals Overmedicate Pediatric Patients?

Is this a case of more is less? Some pediatric hospital patients, especially those with unusual disorders, are given so many drugs and therapeutic agents that their treatment is raising questions of unacceptable risks.

Readers of a report published in the Archives of Pediatrics and Adolescent Medicine are certainly invited to draw that conclusion.

The problem isn’t necessarily the number or nature of the drugs, but the fact that many facilities lack an established, scientific protocol for child safety in administering them.

Like adults, children often are given prescription drugs for “off-label” uses -- that is, to treat a problem other than the one for which the medication was developed. And also like adults, children sometimes are victims of medication errors. The groundswell of legislation in the last decade to improve the labeling and administration of medication to children is testimony to the need to separate the the determination of dosing for adults and for children.

“To advance this agenda,” the study authors wrote, “we need to refine our knowledge of the overall patterns of pediatric inpatient drug and therapeutic agent use, including what drugs and therapeutic agents are used most commonly, the number of different drugs and therapeutic agents that hospitalized children receive, and potential differences in drug and therapeutic agent exposures across different types of hospitals.”

The researchers surveyed academic medical centers, community-based hospitals and large systems of multiple hospitals. They studied more than 700,000 pediatric patients across 411 different hospitals.

The drugs most commonly given were acetaminophen (Tylenol), albuterol (for relief of respiratory issues such as asthma) and antibiotics.

On the first day of their stay in a children’s hospital, patients younger than 1 received 11 drugs and older patients received 13. In a general hospital, kids younger than 1 got eight drugs and those older got 12. By day seven of hospitalization in a children’s hospital, the youngest babies had received 29 drugs, and the older childern had gotten 35. General hospital figures were 22 and 28 respectively. The odder the illness, the more likely it would attract greater drug exposure.

That’s a lot of medicine for a developing body to metabolize, and while that is neither positive or negative, the sheer volume bears scrutiny. The authors suggest that:


  • ranking the drugs and frequency of their use for hospitalized children can suggest priorities for further research;

  • the use of multiple drugs raises concern for patient safety because such “polypharmacy” (multiple drugs) in adults has shown adverse effects;

  • establishing a database of use offers opportunities to compare effectiveness and study safety.


The point is to learn if pediatric patients receive too many drugs, too few and/or in the proper combination.


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July 25, 2011

Rat Study Suggests Problems for Ritalin & Prozac Combo for Teens

Many adolescents diagnosed with depression and attention deficity-hyperactivity disorder (ADHD) are prescribed both methylphenidate (Ritalin) and fluoxetine (Prozac). A study on rats given the two drugs might give humans pause.

As reported in the Los Angeles Times, the study showed that adult rats who got that drug combination as pups were more likely than those with no early exposure to psychotropic drugs to choose highly sugared water over plain water, and to linger in a compartment where they had gotten a dose of cocaine, which suggests they were hoping for more. Those are disturbing signs of developing addiction.

"Taking Ritalin and Prozac together during adolescence appears to set in motion subtle changes in brain function that, in adulthood, makes an individual more sensitive to reward as well as to stress, and more likely to exhibit the pessimism and hopelessness seen in depression," was how The Times summarized the study published in the Journal of Neuroscience.

The study's authors wrote, "combining methyphenidate and fluoxetine early in life may lead to lifelong behavioral and chemical abnormalities." They said the drugs--one a stimulant, one an anti-depressant--in combination appeared to act on the brain in much the same way as does cocaine.

Those drugs affect production of certain proteins in the brain's reward circuitry. If it's disrupted during adolescence, the adult later might struggle with the ability to regulate mood and to moderate reward-seeking behavior such as eating or sexual activity.

Baby rats who got only Prozac seemed more sensitive to rewards as adults, but were also more resilient to stress than those who didn't. The rats who got only Ritalin demonstrated less inclination toward sugar water, as well as a "significant aversion to cocaine" as adults--a sign that treating ADHD might thwart drug abuse later. But they also showed greater sensitivity to stress later on.

A rat is not a kid, and a trial subject rat is not depressed or afflicted with ADHD. So no straight line can be drawn between the study results and a child with these disorders who takes these drugs. If the study is notable, it is too preliminary for parents to withhold these drugs if they've been prescribed for their children with mood and behavioral problems. It's never too early, however, for a conversation with your doctor about the appropriate use of prescription drugs, and alternative treatments.

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May 31, 2011

Finally, FDA may require Tylenol dosing information for children 2 and under

An FDA advisory panel has voted 21-0 in favor of adding dosing instructions to Children’s Tylenol and other products containing acetaminophen for children between 6 months and 2 years.

Currently, the liquid formulas do not contain dosing information for children under 2. Panel members said the lack of information can lead parents to give their kids an incorrect dose of the drug.

Acetaminophen-related overdoses are most common among children younger than 2, and have increased over the past decade, according to FDA data. While safe when used as directed, acetaminophen has long been subject to warning labels because it can cause serious and even fatal liver damage when overused.

Dosing errors with children’s acetaminophen products accounted for 7,500 of the 270,165 emergencies reported to poison centers last year, according to the American Association of Poison Control Centers.

Overdoses can be caused by parents not reading the label, misinterpreting the dosing instructions or using a spoon or other container instead of the cup included with the product.

The panel also voted unanimously that medicines should include dosing information based on children’s weight, and to limit cup measurements to milliliters, because having both teaspoon and milliliter markings can cause confusion.

The proposed changes have been discussed at FDA meetings since the mid-1990s. FDA is not required to follow the recommendations of its advisory panels, though it often does.

Source: Associated Press

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May 26, 2011

Atypical antipsychotic use high in children, study shows

Nearly half the children treated as inpatients for psychotic and mood disorders are given atypical antipsychotics, a new single-center study reports. About 44% of these young patients with a variety of conditions, ranging from psychosis to various mood and anxiety disorders, were treated with either first- or second-generation versions of the drugs, according to the study, which was recently presented at the American Psychiatric Association meeting in Honolulu.

To determine the prevalence of antipsychotic use and associated clinical characteristics - and to compare current use with past use - the researchers looked at 3,851 inpatients ages 5 to 17 who were seen at their facility between January 2000 and June 2010 for various diagnoses, including psychosis, behavioral disorder, depression, post-traumatic stress disorder (PTSD) and anxiety.

They found that antipsychotics were prescribed for 44.3% of patients, and that a higher proportion of those scrips were written for children (ages 5 to 12) than adolescents (ages 13 to 17) - 51.7% versus 41.7%.

Atypical prescribing varied by diagnosis, with prescriptions written for:


• 76% of psychosis patients (including schizophrenia and bipolar disorder)

• 45% of behavioral patients (including ADHD, panic disorder, and social phobia)

• 24% of depression patients

• 46% of PTSD patients

• 31% of anxiety patients

• 20% of patients with other diagnoses


The study authors expected atypical use to be most common in people with psychotic systems, but were surprised to see such high use of atypicals in behavioral diagnoses. The likely explanation is that the study focused on inpatients, who may exhibit more severe behavioral issues than outpatients.

Atypical antipsychotics were also more likely to be prescribed to males, nonwhites and those with a longer length of stay. Surprisingly, the general use of atypicals decreased over the study period, from 47% between 2001 and 2003 to 43.5% between 2006 to 2010.

The study was limited because it was done at a single center and because it lacked follow-up after discharge, and the study authors called for further study and the need for comparison with other institutions.

Source: Medpage Today

Study reference: Stevens M, et al "Current prescribing practices: antipsychotic use in children and adolescents" APA 2011; Abstract 12-41

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April 14, 2011

Benzocaine products carry risk of blood disorder, FDA warns

The Food and Drug Administration (FDA) says it continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

Methemoglobinemia is a rare but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate.

While methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, most cases occurred in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

The FDA recommends that Benzocaine products not be used on children under 2 years except under the advice and supervision of a healthcare professional. It also recommends storing these products out of the reach of children.

Source: Food and Drug Administration

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December 30, 2010

French study prompts FDA concern about growth hormone

The Food and Drug Administration (FDA) has undertaken a review of recombinant human growth hormone (somatropin) after a French study determined that some kids who take it because they are abnormally short may be at a small increased risk of death.

The FDA does not recommend that patients stop taking recombinant human growth hormone before talking to their physicians, as it believes the benefit of the hormone still outweighs its potential risks. However, the FDA is now reviewing all available information on this potential risk and plans to issue new recommendations, if necessary, once the review is completed.

Meanwhile, healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program here.

Recombinant human growth hormone, a manufactured protein that is nearly identical to the main form of the naturally occurring human growth hormone, can stimulate tissue growth, protein, carbohydrate, lipid and mineral metabolism, and increases in height and weight.

In the U.S., it is used to treat children with short stature due to growth hormone deficiency (including idiopathic growth hormone deficiency), Turner syndrome, Noonan syndrome, Prader-Willi syndrome, short stature homeobox-containing gene (SHOX) deficiency, chronic renal insufficiency, and idiopathic short stature, as well as children small for gestational age. Recombinant human growth hormone is marketed under the following brand names: Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin.

Source: Food and Drug Administration

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December 22, 2010

Dosing directions in children’s medications found wanting

Given the importance of correct dosing of over-the-counter pediatric medicines, you would think that the labeling on the package and the dosing information would be clear and understandable for parents. Unfortunately, a recent study published in the Journal of the American Medical Association (JAMA) says that is usually not the case, with potentially deadly results.

The study examined the directions and measuring devices in 200 non-prescription pediatric liquid medicines for allergy, cough and cold, pain and gastrointestinal problems, as well as some combination medicines, over one year ending Nov. 1, 2009. The sample represented 99% of over-the-counter liquid pediatric medicines sold in the United States.

Researchers found that 52 medicines did not include a measuring device, and that 146 of the other 148 had inconsistencies between the dosing directions and the devices, including missing or superfluous markings, unfamiliar units of measurement (for example, drams or cubic centimeters), or undefined or nonstandard abbreviations. More than 24% of the medications that did include measuring devices had missing markings, while 120 had superfluous markings. Meanwhile, 11 of the 200 medications used little-known units of measurement, such as drams and cc, for doses listed.

The Food and Drug Administration (FDA) published voluntary guidelines for labeling of dosing directions and measuring devices for over-the-counter liquid medicines in November 2009 and expects to see changes by next winter, according to the study’s lead author, Dr. Shonna Yin. At that time, Yin says, the study will be redone to determine if the voluntary guidelines work.

Source: The New York Times

You can view the JAMA abstract here.

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September 1, 2010

Are Too Many Pre-Schoolers Being Put on Anti-Psychotic Drugs?

Prescriptions of anti-psychotic drugs like Risperdal for pre-school kids have doubled in the last few years, according to a recent study from Columbia University. Now there are an estimated 500,000 children and adolescents receiving such drugs in the United States. Is it too much?

Only four in ten of the preschoolers who receive prescriptions for these powerful drugs have been given a proper mental health assessment, according to the Columbia study. That worries some experts. As one told the New York Times:

“There are too many children getting on too many of these drugs too soon.”

This quote was from Dr. Mark Olfson, professor of clinical psychiatry at Columbia and lead researcher in the new study, which was financed by the government.

Olfson and other researchers worry that the drugs can interfere with physical and mental development in young children. What many kids need is talk therapy, but it's cheaper and more convenient to medicate them, they say.

Read more in the Times' article here.

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October 29, 2009

Do Mental Health Drugs Make Kids Fat?

An article recently published in the Journal of American Medical Association documents findings that associate atypical antipsychotics to weight gain in children who are first-time users of the drugs. The study, headed by Dr. Christoph Correll in New York, includes 272 youths age 4 to 19 and is “the largest and most definitive to date to establish a link between the drugs and weight gain,” writes Jonathan Rockoff of the Wall Street Journal.

The JAMA study examined four top-selling atypical antipsychotics (powerful drugs prescribed to treat schizophrenia and bipolar disorder): Abilify, Risperdal, Seroquel and Zyprexa. Among them, Zyprexa was found to cause the most weight gain: 19 pounds in 11 weeks. It was also found to “significantly raise levels of blood sugar, cholesterol, insulin and triglycerides,” thereby increasing users’ risk of diabetes and heart problems. Patients taking other three medications had an average of 10 to 13 pounds of weight gain.

Dr. Correll, the lead author of the study, recommends using extra caution in prescribing these atypical antipsychotics to youths under the age of 18, and encourages psychiatrists to frequently monitor the weight and metabolic rate of those who are taking these drugs.

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March 27, 2009

New Questions about Drugs for Attention Deficit Disorder in Kids

Thirty-nine million prescriptions were written for American children in 2008 for drugs like Adderall and Concerta to treat attention deficit hyperactive disorder (ADHD), but new research suggests the drugs have only short-term benefit and may pose more harm to children than good if given for more than two years.

In a report in the Washington Post by Shankar Vendatam, scientists involved in a large federal study of the drugs sharply disagreed with one another about what the public should be told about their study results. One psychologist in the group of researchers said that parents needed to know that careful comparisons of the children in the study showed definite advantages of the drug treatment only in the first twenty-four months of use, and that longer use resulted in stunted growth, with drug-treated children typically an inch shorter and six pounds lighter than non-drug treated peers after 36 months of treatment. Another psychiatrist who participated in the study said long-term benefits were real but hard to demonstrate statistically.

The study is called the Multimodal Treatment Study of Children With ADHD (MTA). When its initial results were first published in 1999, a clear advantage was seen for behavior improvement in children who had taken the ADHD drugs in the first fourteen months of the study, compared to children who received only talk therapy or no treatment at all, and those results ignited a huge wave of popularity for the ADHD drugs with pediatricians and parents. But as the researchers have continued to follow the same children over the years, the advantage of drug therapy, at least as measurable statistically, disappeared.

Statistics, of course, do not necessarily apply in any one individual case. The take-away for parents is to be careful about any long-term use of drugs in their children and to continue to ask questions of doctors, and reach your own informed decisions about what to do.

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November 21, 2008

Overmedicating Children and Doctors' Conflicts of Interest

Nearly every week, we hear more evidence that American children are over-medicated, especially with drugs that affect mood and behavior. Most recently, a panel of experts has denounced the overuse of Risperdal, a powerful antipsychotic drug, for attention deficit disorder. The drug has too many side effects, including potential development of permanent muscle twitching, to justify its use in mild conditions like ADD for which other options exist, according to the expert panel convened by the Food & Drug Administration to advise it on labeling changes.

What is behind the explosion in use of antipsychotic drugs in children (besides Risperdal, they include Zyprexa, Seroquel, Abilify and Geodon) is a drumbeat of support from leaders in child psychiatry. But that leadership is tainted by their ties to the drug industry -- ties that frequently don't get mentioned in public when these same doctors are lecturing their colleagues and advising worried parents. One leader, Dr. Joseph Biederman, a child psychiatrist at Harvard, was revealed by a Congressional investigation to have accepted $1.4 million from manufacturers of antipsychotic drugs that he did not disclose to his university. Another psychiatrist leader, Dr. Charles B. Nemeroff of Emory, had to step down as chair of psychiatry after it was revealed that much of his consulting pay from drug makers, which totaled over $2.8 million in seven years, had been hidden from his university.

Now another influential psychiatrist has been exposed for his secret ties to the drug industry. He is Dr. Frederick Goodwin, former chief of the National Institute of Mental Health, who hosted a popular show on National Public Radio, "The Infinite Mind." Senator Charles Grassley of Iowa released data to the New York Times showing that Dr. Goodwin received $1.3 million from drug manufacturers from 2000 to 2007 for giving marketing lectures to other doctors. The money was never mentioned on his radio show, and NPR now says the show has been canceled and all reruns will stop soon.

According to the Times' Gardiner Harris, on one day in 2005, Dr. Goodwin received $2,500 from GlaxoSmithKline to give a talk about its mood stabilizer drug Lamictal at a Ritz Carlton resort in Florida. On his radio show broadcast the same day, Dr. Goodwin said that children with bipolar disorder who did not get treatment could suffer brain damage (a controversial prognosis) but he reassured his listeners that mood stabilizer drugs were a safe and effective way to treat the problem.

Senator Grassley has sponsored legislation to require drug makers to post publicly all the payments they make to doctor consultants. That would help the public to know whether the recommendations they see from doctors for medicating their children are truly unbiased or should be taken with a grain of salt.

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August 31, 2008

FDA Revisits Cold Medicine Standards for Infants

We have discussed concerns over the efficacy and safety of cough and cold medicines for very young children many times in the past.

Now, in reaction to these concerns, the FDA plans to take another look at the reasons why these cough and cold medications were approved for toddlers and infants in the first place. From the article:

In response to rising concerns that the products are ineffective and could be unsafe, the agency said it will revamp the criteria that have allowed the products to remain on drugstore shelves for the first time in decades.

"Modern science has advanced since, and this is an opportunity to apply modern science to evaluate these products,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

As the first step in that process, the agency will hold a special hearing Oct. 2 to begin to consider a series of questions, including: What types of studies should be done to evaluate the products? Should the products remain available without a prescription? How should the doses be determined? Should products that combine different ingredients remain available?

One problem that has led to preventable tragedies is that parents sometimes inadvertently overdose their children. A particular problem has been with concentrated Tylenol infant drops. Due to confusing instructions from pediatricians and to labeling that wasn't always clear, some parents have not realized that the infant drops contain much more of the active ingredient, acetaminophen, then regular children's Tylenol. An overdose of Tylenol or acetaminophen can cause liver poisoning which requires liver transplant. After years of complaints, the Tylenol manufacturer took the concentrated infant drops off the market in October 2007.

The FDA's new look promises to go beyond the infant drops issue and look at the appropriate place of cough and cold medicines in treatment of infants and toddlers.

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March 27, 2008

UK Bans Cold Medications For Children Under 2

On this blog, we have discussed concerns over the efficacy and safety of cough and cold medications for very young children and babies many times.

Today, the Medicine and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has removed these medications from the shelves. Most of them will be allowed back on the shelves after the addition of a warning label saying that they should not be used on children under 2. From the article:

Sara Coakley, spokesperson for the MHRA, told BBC News it was a precautionary measure and the medicines are not dangerous.

"There's nothing wrong with these medicines, it was the way that they had been given," she said.

There was no need to panic, said Coakley, they would not be on the shelves in the first place if they were inherently dangerous.

The alert concerns 12 active ingredients: brompheniramine, chlorphenamine, dextromethorphan, diphenhydramine, ephedrine, guaifenesin, ipecacuanha, phenylephrine, pholcodine, pseudoephedrine, oxymetazoline, and xylometazoline.

According to Times Online, at least 5 deaths of children under the age of two and more than 100 cases of serious adverse events have been linked to cough and cold medicines in Britain.

The danger occurs when a child is given too much of the cough medicine or has more than one at the same time. Small children are more at risk of overdose because of their smaller body size, said the MHRA.

The MHRA is encouraging parents to give their children simple remedies like honey and lemon.

For more information, see the older discussions linked at the beginning of this post.

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February 8, 2008

Cold Medicines, Children and Emergency Rooms

Around 7,000 children per year have to go to the emergency room because of cold medicines.

The study was done by the Centers for Disease Control and Prevention. Points to note:

-two thirds of the cases involved children taking the medicines without proper adult supervision or direction;

-one-quarter of the cases involved parents giving children the proper, recommended dosages;

-this study follows other stories that might raise concern about cold medicines and very young children, such as the FDA warning against such medicines for toddlers, a lawsuit filed by the mother of a boy who died after taking common cold medicines, and a voluntary recall by Tylenol, Dimetapp and others.

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December 12, 2007

Honey a Better Cough Medicine for Kids than Dextromethorphan

Recently, many have raised questions about the efficacy and safety of common cough medicines for children, many of which include the ingredient dextromethorphan.

But now an easy substitute seems to have been found: honey. Specifically buckwheat honey, which a new study has found to be more significantly more effective than dextromethorphan in curing coughs in young children. The study examined and compared the effects of dextromethorphan, honey and no treatment at all in 105 children. Honey was more effective than no treatment, whereas dextromethorphan was not.

The effective dosages of honey were: half a teaspoon for children aged two to five, a full teaspoon for those aged six to eleven and two teaspoons for the twelve to eighteen age group.

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November 21, 2007

Cold Medicine Lawsuit

A month after the FDA change in labeling guidelines for cough and cold medications for children and a voluntary recall of those products, the mother of a boy who died after taking cold medication is filing a lawsuit.

The baby, son of Dimitria Alvarez of Illinois, was four months old. He died after taking Infant Tylenol Cold Decongestant Plus Cough and Walgreen-brand Pediatric Drops-Cough Plus Cold, according to the mother. The commonality between these two drugs is that they contain dextromethorphan, which is found in many cough and cold medications, including many of those recalled.

For more information on the uses of dextromethorphan, see this page from Medline Plus.

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October 24, 2007

Cough Medicine and Kids

The Food and Drug Administration plans to meet to discuss the efficacy of cough syrup and cold medications for children. This comes on the heels of a voluntary recall of more than a dozen brands of children’s cough and cold medications, including Dimetapp, Robitussin, Tylenol and many others.

The FDA has already ordered a change of label guidelines for the use of such medications on children two or younger. Doctors are pushing for an outright ban, and also for restrictions for children up through age six. No study has been done demonstrating the safety of these medications on children, and quite a few have been done showing that they are no more effective than placebos and that overdosing is a serious problem. Parents, believing cough syrup to be completely mild and harmless, run the risk of giving overdoses to toddlers and very small children.

For more information and commentary:
Why give children placebos?

Doctors discourage use of cough syrup

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August 17, 2007

FDA cautions against OTC cough and cold medicines for toddlers

On Wednesday, the FDA (Food and Drug Administration) issued a statement saying that children under 2 should not be given over-the-counter cough and cold medicine unless it's because of specific instructions from a healthcare provider.

What is the reason for this public health advisory? The FDA does not say, confining itself to a vague assertion that cough and cold medications may cause "harm" to extremely young children.

However, the Baltimore City Health Department submitted a petition to the federal government asking for tighter regulation of marketing for such drugs on behalf of several Maryland physicians, pointing to studies suggesting that these drugs are neither effective nor safe in children under 2.

The CDC (Centers for Disease Control) also has some important information about the effects of such drugs on very young children. An interview of theirs with Dr. Adam Cohen, who investigated infant deaths to to cold and cough medicines, is a good resource for some general facts on this topic.

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