FDA warns of suicide risk with Paxil

May 15 2006

The Food and Drug Administration (FDA) in the U.S., has notified healthcare professionals in the States and the UK that the antidepressant Paxil produced by GlaxoSmithKline (GSK), appears to raise the risk of suicide in young adults.

GSK the largest drug company in Europe says a new analysis of data from clinical trials has found a higher rate of suicidal behaviour among adults under the age of 30 who took Paxil than others who took a placebo.

In this latest analysis it was found that out of 3,455 who took Paxil for depression 11 attempted to commit suicide, though none of them succeeded.

Most of the attempts were apparently in young adults aged 18 to 30.

No increased risk of suicidal behaviour was found in adults older than 30.

GSK has notified health regulators around the world and practitioners both in the UK and the U.S. are being advised to monitor patients closely during treatment.

A change in the current labelling is not expected.

Antidepressants have been closely scrutinised since studies first linked them to an increase in suicidal behaviour two years ago.

Since then, so-called "black box" warnings on antidepressants have highlighted the risk of suicidal thoughts and actions in teenagers.

It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.

Paxil, which has now come off patent, has been a big money earner for GSK and earned £161m for the company in the first three months of the year.