Welcome! We regret to inform you that the Injury Board National News Desk has been discontinued. Feel free to browse around and enjoy our previously published articles, or visit The Injury Blog Network for the latest in personal injury news.

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

Posted by Chrissie Cole
Thursday, November 20, 2008 2:13 PM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Protecting Your Family, ADHD, Antipsychotic Drugs, Children's Health, Risperdal, Zyprexa, Seroquel, Abilify, Geodon

LEARN MORE

IMAGE SOURCE: © Wikimedia Commons / Risperdal / author: Housed

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. #


1 Comment

Anonymous User
Posted by Nancy
Friday, November 21, 2008 12:13 PM EST

"The agency has little power to rectify the problem." So says Dr. Laughren. Dr. Laughren, it's time to pick up your last paycheck - no bonuses - turn out the lights on the agency - and go home. It would be good riddance. See the list of your conflicts of interest on AHRP.ORG

Comments for this article are closed.

About the National News Desk

Our mission is to seek the complete truth and provide a full and fair account of the events and issues that surround personal safety, accident prevention, and injury recovery.  We are committed to serving the public with honesty and integrity in these efforts.

Hurt in an accident? Contact an Injury Board member

Subscribe to Blog Updates

Enter your email address if you would like to receive email notifications when comments are made on this post.

Email address

Subscribe

RSS Feed

Add the National News Desk to your favorite RSS reader

Add to Google Reader Add to myYahoo Add to myMSN Add to Bloglines Add to Newsgator Add to Netvibes Add to Pageflakes