Tuesday, March 23, 2004

Regulators Want Antidepressants to List Warning
Front page New York Times article - "Patients taking antidepressants can become suicidal in the first weeks of therapy, and physicians should watch patients closely when first giving the drugs or changing dosages, federal regulators said yesterday. The warnings are part of a public health advisory issued by the Food and Drug Administration and are a reminder that antidepressants, taken by millions around the world, are not without risks. The agency is asking drug manufacturers to place detailed caveats about the drugs' side effects prominently on their labels. Advertisement The agency's decision to issue such a broad warning was a surprise. Top F.D.A. officials have long insisted that their decisions are driven only by clear-cut evidence from well-run clinical trials. But in a conference call with reporters yesterday, agency officials said that no studies had shown a convincing link between drug therapy and suicide. Suicide is such a rare side effect that studies on the subject have been difficult to interpret, the regulators said. Still, the agency issued the advisory anyway." [Viewing New York Times resources requires registration, which is free]. See also Suicide Warning Sought for Antidepressants, an AP story reprinted at Yahoo.