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Home Industry News GlaxoSmithKline and FDA issue Seroxat suicide warning

GlaxoSmithKline and FDA issue Seroxat suicide warning

15th May 2006

GlaxoSmithKline and the FDA have told doctors to be aware that in some instances, the use of the antidepressant Paxil – known as Seroxat in the UK – can increase the risk of suicide in adults aged between 18 and 30 years-old. The labelling for Paxil and Paxil CR, also known as paroxetine has also been altered.

The warning comes as Glaxo analysed the findings of a study involving 15,000 patients. During the tests, 11 patients using Paxil attempted suicide (with no fatalities), compared to one patient using the placebo. Glaxo said that the results should be treated with caution and it added that the benefits of Paxil use far outweigh the possibility of negative side-effects.

The letter, directed to psychiatric and medical professionals, stated: “It is difficult to conclude a causal relationship between paroxetine and suicidality due to the small incidence and absolute number of events, the retrospective nature of this meta-analysis, and potential for confounding by the fact that the events of interest are a symptom of the psychiatric illnesses themselves.”

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

Glaxo launched paroxetine in 1992 as an antidepressant. It has also been used for treating obsessive-compulsive disorder and social anxiety disorder. Other noted side-effects include paraesthesia, which produces electric-shock-like feelings, dizziness and gastrointestinal upsets.

In the past, the drug has been the subject of lawsuits regarding the alleged withholding of side-effects information, which prompted Glaxo to make all studies concerning paroxetine publicly available.

track© Adfero Ltd

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