Mental Health Blogs

The FDA psychopharmacology advisory committee next week is slated to meet to evaluate safety and efficacy data for three atypical antipsychotics (Seroquel, Geodon and Zyprexa) for use in 13 to 17 year olds diagnosed with schizophrenia and with 10 to 17 year olds diagnosed with so-called pediatric bipolar disorder. The committee will then vote on what recommendations to make to the full agency on these drugs which have proven extremely problematic in adults

Today the FDA itself released its briefing package for committee members (note: the packages are huge and not recommended for download unless you have a technical need for them) and in his introduction FDA psychiatry products chief Thomas Laughren put it like this:

“Although the Division has not yet reached a final conclusion for these applications, we generally are in agreement that the sponsors have provided adequate support to suggest effectiveness for these products for the claimed indications. In addition the safety profiles for these products in these pediatric populations studied appear to be qualitatively
similar to those observed with these drugs in adult patients….

“All of these drugs also have significant risks that must be considered, both by FDA in deciding whether or not to approve these claims and also by clinicians in deciding whether or not to use these medications in treating these serious disorders. Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia. These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development.”

I have no idea where the committee will go with all of this, but you’d hope that if they recommend approval for either indication then they would do so with a plea that the agency order significant warnings be placed on the drugs for use in kids. There is simply so much weight gain in the Seroquel and Zyprexa packages to justify making parents, kids and doctors highly aware of the problem.

Go to Source

Related posts:

1. Perspective On Antipsychotics For Kids FDA Panel Recommendation
2. FDA Panel Recommends Approval Of Antipsychotics For Kids Aged 10, Older
3. Study: Medicaid Kids Get Antipsychotics At Four Times The Rate Of Privately-Insured Kids
4. JAMA Study Finds Explosive Weight Gain In Kids On Antipsychotics
5. Questioning Antipsychotics In Kids, SF Chron Supports Their Use