Child Safety Blog

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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Posted In: Medication , Mental Health

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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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Posted In: Medication , Mental Health

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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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Posted In: Medication , Mental Health

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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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Posted In: Infants , Medication , Product Liability

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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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Posted In: Medication

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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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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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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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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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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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Posted In: Medication

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