When an FDA advisory panel meets tomorrow to talk antipsychotics, members will have a lot of data to sift through in determining whether to recommend their use in children and adolescents. The agency's own analysis shows just how the debate is likely to stack up: six-of-one, half-dozen-of-another. Yes, the three antipsychotics under consideration do effectively treat bipolar disorder and schizophrenia in kids. But the drugs carry significant risks as well.
Up for debate are AstraZeneca's Seroquel, Eli Lilly's Zyprexa and Pfizer's Geodon. Should they be OK'd for use in children and adolescents ages 10 to 17? These atypical antipsychotics have come in for their fair share of criticism for weight gain, sedation and other side effects. Seroquel and Zyprexa have spent plenty of time in court as lawyers debate those side effects--as well as such questions as, do the drugs trigger diabetes? Does the weight-gain side effect lead to heart disease?
The FDA is painfully aware of the potential for severe side effects. "These risks are of particular concern in pediatric patients because of the life-long nature of these disorders," Thomas Laughren, director of the FDA's psychiatric product division, wrote in a memo posted on the FDA website. And even the drugmakers admit that kids using these products might be more at risk than adults are. Lilly reported to FDA that Zyprexa was associated with greater weight gain and blood-lipid changes in kids than in adults. AstraZeneca said side effects that occurred more frequently in children using Seroquel included increased blood pressure and increased appetite. Pfizer said kids on Geodon were more likely to experience sedation than adults were; weight gain and metabolic risks were minor, the company said.
What will the panel make of this data? We'll find out this week. Members convene tomorrow and Wednesday to discuss.
- read the Wall Street Journal story