Published December 05, 2006
The FDA reviewed data from 372 clinical studies involving 11 antidepressants including Paxil from GlaxoSmithKline PLC, Zoloft from Pfizer Inc. and Prozac from Eli Lilly & Co. The studies involved almost 100,000 patients.
The FDA requested the data from antidepressants makers last year in the wake of evidence the drugs increased suicidal thoughts and behavior in children and adolescents, to see if the same risk carried through to adulthood. The drugs carry a "black-box" warning about the increased risk in suicidal thinking and behavior in children and adolescents. Doctors and caregivers are advised to carefully watch for any changes in patient behavior after starting treatment with an antidepressant.
Long-term antidepressant use by both children and adults has generally been associated with a decrease in actual suicides, but there's concern the use of such drugs in the short-term increase thoughts about suicide or suicide attempts in certain patients, particularly in the first few months after starting treatment.
Overall, the FDA review of the data, which dates back to 1985, suggested a "differential risk of antidepressant-induced suicidality across the age spectrum." The agency said, in documents posted to its Web site, that the risk was greater at the younger end of the spectrum and that it declined with age.
The FDA review of the adult antidepressant data was posted ahead of a Dec. 13 advisory committee meeting of outside medical expects to discuss how to update drug labels.