FDA mulls teen antipsychotics

June 10, 2009

The FDA is in a quandary about whether to give approval for child use of three antipsychotics.

The Food and Drug Administration (FDA) is in a quandary about whether to give approval for child use of three antipsychotics.

On the one hand, mental health prescribers can already write off-label scrips for the three medications, all common for treating adult bipolar disorder and schizophrenia. AstraZeneca’s quetiapine fumarate (Seroquel), Eli Lilly’s olanzapine (Zyprexa), and Pfizer’s ziprasidone HCl (Geodon) have all applied for an additional indication for children 10 to 17, which would allow them to promote the use. Two antipsychotics are already approved: risperidone (Risperdal) by Johnson and Johnson and aripiprazole (Abilify) by Bristol-Myers Squibb and Otsuka.

On the other hand, the pediatric clinical studies done by the drug companies showed some increased dangers. Pediatric olanzapine was linked to weight gain and an increased rate of blood lipids. Quetiapine fumarate increased appetite and raised blood pressure for adolescent users more than adult users, studies show, and caused tremors in some. Ziprasidone HCl seemed the best on paper for kids, with slight weight gain and reported sensations of sleepiness.

All three drugs were also shown to be effective in treating the symptoms of bipolar and schizophrenia. An FDA panel is meeting on Tuesday and Wednesday to determine if the three drugs will be approved.