US FDA urges new adult warnings on antidepressants
Last Updated: 2007-05-02 12:49:25 -0400 (Reuters Health)
WASHINGTON (Reuters) - All antidepressants should carry new warnings about an increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during initial treatment, U.S. health officials proposed on Wednesday.
The warning should appear in a "black box" that already cautions about the chances of suicidal behavior in children and teens who take the drugs, the Food and Drug Administration said.
It also should state that adults 65 and older who are treated with the drugs have a decreased risk of suicidal thoughts and actions, and emphasize that depression and some other psychiatric disorders "are themselves the most important causes of suicide," the FDA said.
Studies showed a "slight increase" in suicidal thinking and behavior among young adults during early treatment, which was generally the first one to two months, the FDA said. The data did not find a higher risk for adults older than 24.
Antidepressants include Wyeth's Effexor, Pfizer Inc.'s Zoloft, GlaxoSmithKline Plc's Paxil, Eli Lilly and Co's Prozac and Cymbalta, and Forest Laboratories Inc.'s Lexapro