Approved anti-depressant deemed unsafe


The widely prescribed anti-depressant Paxil has been found by researchers to be neither safe nor effective for the treatment of depression.  

Paxil, also sold under the names Aropax and Seroxat, is a Selective Seratonin Reuptake Inhibitor (SSRI), and was thought to treat a wide range of mental conditions, including major depression, post-traumatic stress disorder, and obsessive-compulsive disorder.

New research published in the British Medical Journal by an international team of pharmacologists suggests that paroxetine (the compound name of Paxil) has no significant benefits for patients suffering from depression; in fact, rates of harm increase when individuals take the drug. The conclusions of the replication study were damning:

“Contrary to the original report by Keller and colleagues [a report used as evidence for FDA approval] our reanalysis…showed no advantage of paroxetine or imipramine over placebo in adolescents with symptoms of depression on any of the prespecified variables”, wrote Joanna Le Noury (Bangor University) and Elia Abi-Jaoude (Toronto) et al.

“The extent of the clinically significant increases in adverse events in the paroxetine and imipramine arms, including serious, severe, and suicide related adverse events, became apparent only when the data were made available for reanalysis.”

Le Noury and Abi-Jaoude were critical of the partiality of the original study, which was conducted with GSK funding. “Researchers and clinicians should recognise the potential biases in published research, including the potential barriers to accurate reporting of harms that we have identified”, they wrote in their conclusion. This new analysis "sets the record straight," said Dr. Fiona Godlee, the editor-in chief of the BMJ.

GSK acknowledged the new study in an email statement:

“[the findings] appear to be in line with the longstanding view that there is an increased risk of suicidality in paediatric and adolescent patients given antidepressants like paroxetine. This is widely known and clear warnings have been in place on the product label for more than a decade. As such we don't believe this reanalysis affects patient safety."

Some see this as a much bigger issue than one particular drug. In an essay accompanying the study, Peter Doshi, associate editor for The BMJ, said the new paper "has reignited calls for retraction of the original study and put additional pressure on academic and professional institutions to publicly address the many allegations of wrongdoing."




MORE ON THESE TOPICS | Big Pharma, clinical trials, conflict of interest, reproducibility

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