DC Child Accident & Safety Blog

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.

We’ve all heard stories about the unthinking transmission of sexually explicit material via telephone texts. We’ve even been a bystander to the more notorious episodes (two words: Anthony Weiner).

But when the willing participants in such naughty trafficking are children, there is less smirking and more worrying.

But a recent study in the journal Pediatrics concluded that kids don’t text sex stuff as much as conventional thought suggests.

“Sexting”—sending or receiving risqué or even explicit photos or videos on a cellphone—is legally fraught when it involves a minor. It’s a criminal offense. It’s child pornography.

Researcher Kimberly J. Mitchell co-authored two studies in Pediatrics, one of which estimates that in 2008-2009, police in the U.S. investigated 3,500-some cases of sexual images sent by adolescents. In 1 of 3 of those cases, an adult received them.

But there doesn’t appear to be an epidemic of kids sending naked photos of themselves to here, there and everywhere, including the Internet. As a story on Reuters.com noted, youth sexting isn’t as common as earlier polls indicated.

A 2008 survey by the National Campaign to Prevent Teen and Unplanned Pregnancy found that 1 in 5 teens has sent or posted online nude or semi-nude pictures or videos of themselves. Mitchell and her colleagues got much smaller numbers in a 2010 national survey. According to phone interviews with more than 1,500 children 10 to 17 years old, only 2.5 in 100 had appeared in or produced nude or nearly nude photos or videos. And only 1 in 100 did so if only sexually explicit material -- naked breasts, genitals or rear ends -- was included. Around 6 or 7 in 100 adolescents said they'd received such images or videos.

"Overall, our results are actually quite reassuring," Mitchell told Reuters. "With any sort of new technology that kids become involved in there is a tendency to become easily alarmed. What we are instead seeing is that sexting may just make some forms of sexual behavior more visible to adults."

Her advice to parents is to make sure their kids understand the legal risks (being busted for transmitting child porn) and the digital risk of Internet exposure. If someone is a sexting recipient, delete the text immediate and certainly don’t redistribute it.

A spokesman for the National Campaign to Prevent Teen and Unplanned Pregnancy was gratified by the study’s finding, but also a bit skeptical. Bill Albert told Reuters the numbers didn’t surprise him because researchers surveyed younger kids as well as teenagers. As he pointed out, "I wonder if teens are being as truthful as they might be. … It's a good opportunity to sit down with your kid and talk about it."

Mental illness. Depression. Suicide. The dark side of the human condition is sad whenever and whomever it strikes. But when the victims are young people, it seems unacceptably unnatural. Yet suicide is the third most common cause of death among teenagers.

So programs such as TeenScreen that survey young people to determine their risk of depression make sense. Those who seem to be at risk are referred for treatment. But John Horgan, writing in Scientific American, raises profound questions about whether screening teens for mental illness is really a good idea for them, or only for a society that wants to feel as though it is doing something.

Some people are opposed to this mental health screening, contending that these issues are private for the youngsters and their families. They contend that they also promote overprescribing of psychiatric medications.

Horgan agrees with the latter concern, noting that:

• Psychiatrists say that more than 1 in 10 children suffer from mental illnesses — from attention-deficit disorder to full blown psychosis. In 2008, the General Accounting Office estimated that 1 in 16 children is “seriously mentally ill.”


• The number of children so mentally disabled that their families are eligible for government assistance has swelled from 16,200 in 1987 to 561,569 in 2007, a 35-fold increase. During the same period, those requiring government assistance for all other ailments declined from 728,110 to 559,448.


• 3.5 million U.S. children take Ritalin and similar medications for (attention deficit hyperactivity disorder) ADHD, up from only 150,000 or so in the late 1970s -- or about 1 in 23 children from 4 to 17.


• U.S.children consume three times as many ADHD medications as the rest of the world’s children combined.


• A 2002 study estimates that 1 in 40 children 18 or younger takes antidepressants. Numerous studies indicate that whereas antidepressants can provide short-term relief for some children, some treated with antidepressants may experience side effects ranging from anxiety and insomnia to full-blown mania and psychosis.


• Since 1995, the number of children diagnosed with bipolar disorder has multiplied more than 40-fold to roughly 800,000.


• Children diagnosed as bipolar are treated with drugs — notably antipsychotics normally prescribed for adult schizophrenics — that have severe physiological as well as mental side effects, including obesity, diabetes and involuntary tremors.


• More than 500,000 children (including infants) ingest antipsychotics, a trend The New York Times reported has been aggressively promoted by manufacturers of antipsychotics.

The promoters of TeenScreen, Horgan writes, have ties to the pharmaceutical industry.
Some psychiatrists advocate medicating young people deemed to be “at risk” of schizophrenia based on behavior less than compelling or because they have schizophrenic relatives.

"Mental illness is devastating for children as well as adults," Horgan concludes, "and medication, when used wisely and sparingly, can help. But clearly our current approach to treating disturbed young people is broken."

Certainly, a disturbed, dangerously unhappy teenager deserves medical attention and appropriate intervention. But before parents agree to an aggressive regimen of psychotropic drugs, they should fully inform themselves of the side effects and risks. There are a lot of ways to treat depression. Drugs is only one.

It’s parental instinct to want to make a child’s world as safe and normal as possible. And when that world is different from the one most other children live in, parents want to know why.

When a pediatrician’s patient lives in the world of autism, explaining the whys and whats to the parents is particularly daunting. Writing in the New York Times recently, Dr. Perri Klass addressed how she relates to parents of autistic children who want to know the cause and, for prospective parents, how they can reduce the risk for children they’re planning to have.

“[A]lthough there is more research in this area than ever before,” she writes, “it sometimes feels as if it’s getting harder, not easier, to provide answers that do justice to the evidence and also offer practical guidance.”

Autism is a complex disorder that research has shown is driven by both genetic and environmental factors. As Klass describes, “Genes matter, but we usually can’t tell how. Environmental exposures matter, but we usually don’t know which.”

Not much there for parents to work with.

A study of autism in twins showed that fraternal twins were both likely to have the disorder, which seems to compromise the strength of the genetic component (since fraternal twins share fewer genes than identical twins).

A couple of generations ago, when ignorance about all mental disorders was evident far more than common sense, autism was blamed on remote parenting. More recently, a noisy campaign was based on fake science supposedly indicating an association between childhood vaccinations and autism, a theory that has been wholly discredited.

But the genetic influences have been proved scientifically sound, and autism spectrum disorder has been described by the American Psychiatric Association as “among the most heritable of psychiatric disorders.”

This evolution of understanding has led scientists to accept that autism results both from genetic predisposition and from environmental influence. But “environment” is a fluid concept.

As one researcher quoted by Klass put it, it’s “everything that’s not the inherited DNA.” Parents might wonder about the chemical ingredients of the placenta’s soup, about the mother’s nutritional profile, her stress level, about the caustic cleaning products under the sink … They’re all part of a developing fetus’s environment.

According to Klass, “The causal links most strongly supported by research include rubella (measles) infection during pregnancy and prenatal exposure to medications like thalidomide and valproic acid, an anti-seizure drug.” Air pollution and exposure to pesticides have an association with autism, but there’s no evidence of causality.

Phthalates, which are chemicals found in flexible plastic products such as shower curtains and other household furnishings such as carpet and shampoo, can leach out in microscopic amounts and disrupt a variety of developmental processes, including brain development. But, again, they haven’t been shown to be a cause of autism, only as an association with its symptoms.

Bottom line: Autism is a custom-made disorder, and probably the result of several factors.
“So it’s hard — and frustrating — to offer prospective parents advice about avoiding risks we still can’t clearly identify,” Klass observes, “and factors that may differ from family to family.”

You can’t completely sanitize your environment, you can’t turn your uterus into a scientific “clean” room — potential toxins are simply a part life. But Klass does offer prospective parents concerned about autism some advice that’s more a prescription of common sense than a prophylactic:

• Take prenatal vitamins before trying to conceive.


• Ensure your immunizations are up to date.


• Get good prenatal care.


• Discuss the risks and benefits of any medications you take with your doctor.


• Avoid pesticides.


• Don’t microwave food plastic containers.


• Use fragrance-free personal products.

“Still, Klass concludes, “it’s hard to talk about this without terrifying parents. And I wonder if in giving advice about prevention, we risk repeating the errors of the past, making parents feel they’re to blame for a child’s autism because they failed to micromanage an environment full of complex agents with potential to interact with fetal genes in a range of damaging but poorly understood disruptions.”

Few things are as satisfying in the parent-child relationship as affectionate physical contact. But some psychologists have drawn the line at parents sharing their bed with their children. As noted in a story on WebMD, the American Academy of Pediatrics advises parents not to sleep with their infants because of an increased risk of sudden infant death syndrome, but what about toddlers, who often are the ones seeking the comfort of the parental bed?

Not to worry. New research published in the journal Pediatrics says that toddlers who share a bed with their parents do not face increased risks for behavioral or learning problems at age 5.

"The idea that bed sharing may be bad for toddlers is mostly based on folklore," researcher R. Gabriela Barajas of Teachers College of Columbia University told WebMD. "From what we see, there is no additional risk of behavioral and cognitive problems among toddlers who share a bed with their parents."

The study involved children from 944 low-income families who were assessed at ages 1, 2, 3, 4 and 5. Nearly 50% of families said they had shared a bed at least once; 73% of the families in the study were living below the poverty line. The study did not look at why the children were sleeping in their parents' beds, information that could be critical.

"In some higher socioeconomic groups, co-bedding can be a parenting-style issue and in others, it may be trouble-shooting a sleep problem," said Nanci Yuan, M.D., of the Pediatric Sleep Center at Lucile Packard Children's Hospital at Stanford University.

"If it is because you feel like it is bonding and your child is otherwise healthy, growing, and thriving, then bed sharing is not associated with cognitive and behavioral problems," she said.

A new study published in the journal Pediatrics offers insight into why children with attention-deficit/hyperactivity disorder (ADHD) are able to observe safety measures when crossing the street, but often fail to do so.

Seventy-eight children from 7 to 10 years years old were involved in the study. Thirty-nine were diagnosed with ADHD and 39 were typically developing children. Researchers looked at three things: (1) how they evaluated their environment before crossing the street; (2) how they decided to begin crossing; and (3) how safe was the environment after the decision to cross was made.

No significant differences emerged in the latter two factors, but the children with ADHD chose riskier pedestrian environments in which to cross. Researchers concluded that this reflected trouble within the brain's "executive function" -- that is, the kids with ADHD were less able to process perceived information necessary to permit a safe cross.

Mothers of young children concerned about wagging tongues impugning their parenting ability if they also hold jobs can stop worrying. A new study from the United Kingdom determined that "There was no evidence of detrimental effects of maternal employment in the early years on subsequent child socio-emotional behaviour."

The research, published in the Journal of Epidemiology & Community Health, compared parental employment with the social and emotional behavior of their children at three different ages up to 5. Researchers analyzed if the mothers' work status affected the childrens' risk for problems when they were older.

No surprise that the results indicated that the best situation for any child is one in which both mothers and fathers were present in the household and in paid work, regardless of the mother's educational level and the household income.

But, clearly, one formula that does not compute is Mom + Job=Trouble.

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.