Report: Glaxo withheld critical data on antidepressant Seroxat
- The British Medical Journal (BMJ) has criticized GlaxoSmithKline (GSK) for withholding clinical trial data showing that Seroxat (paroxetine) is neither safe or effective in adolescents.
- Seroxat is linked to an increased risk of suicide in pediatric patients.
- Seroxat has carried a black box warning since 2004.
BMJ has implemented an initiative known as Restoring Invisible and Abandoned Trials (RIAT), in order to uncover data, reanalyze it, and force pharmaceutical companies to update or rectify information related to drug trials.
When BMJ analysts re-analyzed previously undisclosed data from GSK's 2001 trial of Seroxat, they found that at least 12 out of 93 pediatric patients taking the drug had developed suicidal thoughts. However, when GSK published the results of the study in the Journal of the American Academy of Child and Adolescent Psychiatry in 2001, their conclusion was that paroxetine is safe and effective in children.
In 2012, GSK was fined $3 billion for fraudulent promotion of several drugs—and paroxetine was one of them. GSK's response to this entire re-analysis has been conciliatory, with the company saying that it helped the BMJ researchers by providing the previously unseen data—part of its commitment to data transparency.