Europe's largest drug maker said new analysis of data from clinical trials found a higher rate of suicidal behaviour among adults under the age of 30 who took Paxil than others who took a placebo.
The latest analysis found that 11 patients out of 3,455 who took Paxil for depression attempted to commit suicide, though none of them succeeded. A majority of these attempts were in young adults aged 18 to 30, while no increased risk of suicidal behaviour was found in adults older than 30.
A spokeswoman for GSK said the company had informed regulators around the world about the new findings and had written "Dear Doctor" letters to all practitioners in the US and Britain, in consultation with the US Food and Drugs Administration. But she stressed: "There is no change to the label and the authorities won't be issuing additional advice. We're just acting proactively to make sure doctors monitor patients closely during treatment. This new analysis reinforces our previous medical guidance that doctors should keep a close eye on patients in the young age range."
Antidepressants have come under renewed scrutiny from regulators 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.
Paxil, which has come off patent, notched up sales of £161m for GSK in the first three months of the year.Reuse content