The FDA has approved the use of Eli Lilly's Zyprexa and AstraZeneca's Seroquel in teenagers with schizophrenia and bipolar disorder. But the agency will be looking for more data on the side effects of these antipsychotics, and whether those side effects are worse in teenagers then they are in adults.
Antipsychotics are already linked to an increased chance of weight gain and diabetes. And next week an FDA advisory panel will discuss what additional warnings will be necessary for use of the drugs in pediatric patients. A study published last month in the Journal of the American Medical Association found that kids on certain antipsychotics added 8 percent to 15 percent to their body weight in less than 12 weeks on the drugs. Pediatric patients on Zyprexa put on the most weight, but patients on several other drugs in the same class gained at least some weight. Given the significant side effects, the FDA will surely have more to say on the matter.
As part of the approval, the FDA said that the antipsychotics should be part of a comprehensive treatment program, which may include psychological, educational and social interventions. Antipsychotics were the best-selling class of drug in 2008, with $14.6 billion in sales.
- check out the WSJ report for more