U.S. Panel Pushes For Study of Antipsychotics Drugs In Children

The long-term effects of prescribing antipsychotic drugs to children needs to be studied, says a panel of outside experts calling on the U.S. Food and Drug Administration (FDA) and other health agencies.

In a routine pediatric safety review on Tuesday, the panel unanimously requested more long-term data on the side effects of using these powerful drugs in children.

Risperdal, or risperidone (Johnson & Johnson) and Zyprexa, or olanzapine, are two ell known atypical antipsychotics. These drugs are increasingly being prescribed to children for off label use, such as attention deficit hyperactivity disorder (ADHD).

“These types of drugs have a high rate of benefit, but they also carry a well known set of risks associated with use,” Dr. Carl Terhune D’Angio, a panel member from the University of Rochester, said in a phone interview.

While panel members spent a good deal of time discussing Risperdal, they said their concerns applied to the other medicines in its class, including Abilify, Geodon and Seroquel.

Although doctors are able to prescribe any FDA-approved drug in a way they deem appropriate, some panel members fear that doctors are over-prescribing, based on too little data to support their safety in children.

Nearly 400,000 children and teens filled prescriptions for Risperdal, one of five well known antipsychotic medications. Of those, 240,000 were 12 or younger, according to data presented to the committee. In several cases, the drug was prescribed to treat attention deficit disorders.

But, Risperdal is not approved to treat attention deficit disorders, and its risks – which include muscular tics, increased diabetes risk, serious weight gain and metabolic disorders, all which can have life-long effects – are too farreaching to justify its use in treating such disorders, said panel members.

Over the last year, prescriptions for Risperdal in patients 17 and younger, has increased 10 percent, while adult prescriptions declined 5 percent.

An estimated 1,200 children taking Risperdal had severe side effects. And 31 children died between 1993 and March 2008. At least 11 of those deaths were children whose treatment with Risperdal was unapproved by the FDA.

The FDA is expected to meet with the National Institutes of Health (NIH) “to discuss a long-term study of medications in this class and will begin closely monitoring specifically how these drugs are being used to treat pediatric patients and their effects, said Sandy Walsh, a spokeswoman for the FDA.

“The agency has little power to rectify the problem. Rather, medical specialty societies need to better educate doctors about the drugs’ side effects, says Dr. Thomas Laughren of the FDA. #