December 12, 2006
Antidepressants raise suicide risk in young adults: FDA
The FDA said that an analysis involving 11 antidepressants showed the drugs appear to raise the risk of suicidal thinking in young adults, but that the risk declines in older adults.
The analysis, posted on the FDA Web site, was intended to see if the increased suicidal thoughts and behavior seen previously in children and adolescents taking antidepressants carried through to adulthood.
The agency reviewed data from 372 clinical studies involving antidepressants such as Paxil from GlaxoSmithKline, Zoloft from Pfizer and Prozac from Eli Lilly. The studies involved almost 100,000 patients, about half of whom took the drugs.
Agency analysts found that those under 25 were 2.3 times more likely than those on placebos to report a suicide attempt or report preparing for one by, say, writing a suicide note. The risk was the same whether the patients were taking newer drugs, like Prozac from Eli Lilly and Lexapro from Forest Pharmaceuticals, or older products, like imipramine. The drugs appeared to reduce the risk of suicidal behavior significantly in people 65 and over.
Suicidal behavior of any kind was rare, the analysts found, with people taking the medications no more likely to kill themselves than those taking placebo.
Antidepressant makers provided the data last year after evidence emerged that the drugs increased suicidal thoughts and behavior in children and adolescents. FDA since 2004 has required drug firms to include black-box warnings on their labels of the increased risk seen in minors, and experts say the new study is likely to shift the same attention to young adults.
An FDA advisory committee on psychotropic drugs is set to meet Wednesday to discuss how to update drug labels.