Glaxo Warns Doctors of Paxil Suicide Risk in Adults Under 30
By: Administrative Account | Source: Bloomberg
May 12, 2006 7:42AM EST

May 12 (Bloomberg) -- GlaxoSmithKline Plc informed doctors that its Paxil antidepressant appears to raise the risk of suicide in adults under the age of 30. Glaxo said that new analysis of data from clinical trials showed that 11 patients out of 3,455 taking Paxil for depression reported an attempted suicide. A majority of these attempts were in young adults aged 18 to 30 years, while no increased risk of suicidal behavior was found in adults over 30 years, the London- based drugmaker said. ``For the vast majority of patients with depression who take Paxil/Seroxat, this medicine helps them to live a normal life,'' Glaxo spokeswoman Gwenan Evans said in an interview today. ``This new analysis reinforces existing medical guidance to closely monitor patients during treatment. This is especially the case in patients with depression, and the under 30 year olds.'' The U.S. Food and Drug Administration is assessing whether antidepressants increase the risk of suicidal thinking or actions among adults, and is expected to announce a decision sometime this summer. In October 2004, the FDA requested that antidepressant makers highlight a risk of suicidal thoughts and actions in children in a so-called `black box' warning on packaging. Glaxo said that regulators around the world have been notified about this new data and it has sent letters to doctors. The FDA and the U.K.'s medicines and Healthcare Regulatory Agency has advised close monitoring of patients taking Paxil.

To contact the reporter on this story: Etain Lavelle in London at at elavelle1@bloomberg.net