FDA Warned Of Frequent Use Of Antipsychotics In Children

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Certain antipsychotic medicines are being prescribed too frequently to children, and FDA should take action to discourage the drugs' growing use, a panel of federal drug experts told agency officials Tuesday, the New York Times reports. FDA officials had proposed that the panel approve the agency's routine monitoring of the safety of the antipsychotics Risperdal and Zyprexa -- made by Johnson & Johnson and Eli Lilly, respectively -- in children and support its previous efforts to highlight the risks of the drugs. Children are especially susceptible to the drugs' side effects, according to the Times. Panel members did not approve the agency's proposals.

Prescription rates of the so-called "atypical antipsychotics" -- which also include Abilify, Geodon and Seroqeul -- are five times higher among children than they were 15 years ago, and more physicians are using them to treat children with a wide variety of conditions, including those for which the drugs are not approved, the Times reports. According to the Times, the drugs' growing use in children "has been driven partly by the sudden popularity of the diagnosis of pediatric bipolar disorder."

Much of the panel's discussion revolved around Risperdal, the Times reports. More than 389,000 children and teenagers were treated with Risperdal last year, and of those patients, 240,000 were ages 12 or younger, according to data presented by the panel. Many were prescribed the drug to treat attention deficit disorders, even though the drug has not received FDA approval to treat such conditions.

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Risperdal prescriptions for patients ages 17 and younger increased by 10%, while adult prescriptions decreased by 5%. According to the Times, psychiatrists wrote most of the pediatric prescriptions. Side effects of Risperdal include weight gain, metabolic disorders and muscular tics that can become permanent. Between 2003 and the first quarter of 2008, 1,207 children experienced serious side effects related to the drug, and 31 of them died. At least 11 of the deaths were among children who had conditions Risperdal did not receive FDA approval to treat.

Daniel Notterman, a senior health policy analyst at Princeton University and a panel member, said, "The data show there is a substantial amount of prescribing for attention deficit disorder, and I wonder if we have given enough weight to the adverse-event profile of [Risperdal] in light of this."

FDA officials said that the drugs have strongly worded warnings about associated risks. Thomas Laughren, director of FDA's division of psychiatry products, said, "I'm anxious to hear what more we can do in the labeling." He added that medical specialty societies should more thoroughly educate physicians about the drugs' side effects (Harris, New York Times, 11/19).

Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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