US cites suicidal acts in adults on Glaxo's Paxil

Last Updated: 2006-05-12 13:22:31 -0400 (Reuters Health)

WASHINGTON (Reuters) - A recent analysis of clinical trial data found a higher rate of suicidal behavior among young adults who took GlaxoSmithKline Plc's antidepressant Paxil than others who took a placebo, U.S. regulators said on Friday.

The Food and Drug Administration said it was reminding doctors to carefully monitor all patients while they are being treated with Paxil, known generically as paroxetine.

In a letter to doctors, Glaxo said it was "difficult to conclude a causal relationship between paroxetine and suicidal (behavior)," in part due to the small number of cases that were reported.

Information from the analysis has been added to the warnings on Paxil's label, the FDA and the company said. The FDA previously told makers of all antidepressants to add warnings that the drugs may raise the chances of suicidal behavior in children and teenagers.