Analysis of Antidepressant Paxil Finds Data on Teen Risk Was Held Back
September 18th, 2015Via: Reuters:
A medical journal criticised British drugmaker GlaxoSmithKline on Thursday for delaying access to key data from a trial of its antidepressant paroxetine (Seroxat, Paxil) that would have shown earlier that it is neither safe or effective in adolescents.
The widely used medicine is linked to an increased risk of suicide in young people and has carried a Food and Drug Administration (FDA) “black box warning” advising against its use in adolescents since 2004.
Britain’s Medicines and Healthcare Products Regulatory Agency recommended in 2003 that antidepressants like paroxetine should not be used in children or adolescents, and European regulators followed suit in 2005.
But, writing in the British Medical Journal (BMJ), researchers who re-analysed a paroxetine study first published in 2001 said the drug’s dangerous side effects could easily have been highlighted years earlier.
“This is fundamentally about correcting the scientific record,” said Peter Doshi of the University of Maryland School of Pharmacy in the United States, a BMJ associate editor.
The re-analysis used previously unseen data from records of patients involved in the trial and found that at least 12 out of 93 children taking the drug had developed suicidal thoughts.
