Glaxo says Paxil suicide study flawed, misleading

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GlaxoSmithKline Plc on Monday slammed a study from scientists in Norway suggesting its antidepressant Paxil was linked to an increased suicide risk in adults, arguing that the research was flawed and misleading.

The strongly worded statement from Europe’s biggest drugmaker highlights industry sensitivity to drug safety issues, after a Texas court awarded $253 million against Merck & Co. Inc. in a case over its painkiller Vioxx last week.

GlaxoSmithKline’s Paxil and other similar drugs have previously been linked to suicide risk in children, and doctors around the world have been warned they should not generally be used among under-18s.

But researchers at Oslo University wrote in the BMC Medicine journal that the drug also seemed to affect adults in the same way.

Their analysis of trials involving more than 1,500 patients found seven suicide attempts among those taking the drug and only one among those taking a placebo.

GSK said the analysis was misleading as it focused on incorrectly selected data, collected 15 years ago when GSK was seeking approval for the medicine, which is also known as Seroxat and paroxetine.

“It serves only to cause confusion and unnecessary concern for patients using an SSRI (selective serotonin reuptake inhibitor), such as paroxetine, for treatment of Depression," GSK said.

“The sub-analysis also fails to acknowledge the current body of data, which is significantly more extensive and which has been recently reviewed by EU authorities.”

Experts at the European Medicines Agency earlier this year reaffirmed the positive benefit-risk for Paxil in the treatment of adult anxiety and Depression.

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Also read about this study: Paxil may raise suicide risk in adults

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