Researchers have criticised GlaxoSmithKline (LON:GSK) for delaying access to safety data from a trial of its antidepressant paroxetine, marketed as Seroxat in Europe and Paxil in the US. The researchers claim that the drug’s dangerous side effects in adolescents should have been highlighted years earlier.
GSK’s share price has been little changed in today’s session, having inched 0.04 percent higher at 1,298.50p as of 09:22 BST. The shares are outperforming the broader London market, with the benchmark FTSE 100 index having slipped about 0.3 percent into the red.
Experts writing in the British Medical Journal (BMJ) re-analysed a Seroxat study first published in 2001, arguing that the antidepressant’s dangerous side effects could have been highlighted years earlier. GSK’s widely-used antidepressant is linked to an increased risk of suicide in young people and has carried a Food and Drug Administration (FDA) ‘black box warning’ since 2004, advising against the drug’s use in adolescent patients.
The re-analysis focused on previously unseen data from records of patients who participated in the trial and found that at least 12 out of 93 children taking the drug had developed suicidal thoughts. The original study, dubbed ‘Study 329’, was published in 2001 and reported paroxetine as safe and effective for adolescents.
“What would have happened if this data were available 15 years ago when the study was originally published?,” Peter Doshi of the University of Maryland School of Pharmacy in the US, a BMJ associate editor, told Reuters. “Would the black box warnings from the FDA have come earlier?”
The newswire also quoted GSK as saying in response to the re-analysis that it had assisted by providing access to detailed data from the original trial.
“This reflects our commitment to data transparency,” the company said, adding it had now pledged to publish the results of all its studies, whether they are positive or negative.