A Food and Drug Administration reexamination of data linking the pediatric use of some antidepressants to increased suicidal tendencies has once again found a connection, and the agency is actively considering new warnings to highlight the risk.
In a memo released by the agency as part of its preparation for an expert advisory panel meeting on the subject next month, FDA medical officer Andrew D. Mosholder said that he still sees a significant association between short-term use of antidepressants by children and an increase in their thoughts of suicide.
The agency had reacted cautiously to Mosholder's first report on the association in March and asked for additional outside analysis. Based on that new analysis of data from trials of antidepressant drugs, Mosholder found a similarly significant correlation -- that children using the drugs were 1.8 times as likely to have suicidal tendencies as depressed children who took placebos, according to The Washington Post. The FDA has scheduled an advisory panel of outside experts to review the information Sept. 13-14 and make recommendations on whether and how the antidepressants should be prescribed for children, said The Seattle Times.
Antidepressant drugmakers such as Pfizer Inc., GlaxoSmithKline Plc and Wyeth will have to disclose trial results suggesting a higher risk of suicide among children and teenagers taking the pills, U.S. regulators said.
The Food and Drug Administration will require companies to include the information on labels for depression drugs, used by more than 1 million Americans under age 18, according to a study by pharmacy-benefit manager Express Scripts Inc. The agency has been examining the potential risk since it warned last year against any use of Glaxo's Paxil in children and teenagers, citing reports of suicide attempts and thoughts.
U.S. regulators moved after New York Attorney General Eliot Spitzer accused Brentford, U.K.-based Glaxo, Europe's largest drugmaker, of hiding study data suggesting Paxil might increase the risk of suicide among children. The American Medical Association on June 15 asked the U.S. to require drugmakers to disclose all study results, told Bloomberg.