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TV investigations linked to increased adverse drug reports

The number of adverse reactions reported by UK doctors to the antidepressant paroxetine - marketed as Seroxat/Paxil by GlaxoSmithKline - have risen by over 60% after three editions of the BBC current affairs program Panorama explored safety concerns associated with the drug.

Research published in the British Journal of Clinical Pharmacology shows a sudden increase in reports immediately after each of the three programs were aired in the UK in October 2002, May 2003 and October 2004.

Five regulatory announcements made in the UK during the same period resulted in a much smaller 5% increase in reports of adverse reactions.

The research team from the Department of Social Medicine at Bristol University explored prescribing patterns and adverse drug reports for paroxetine, which belongs to the selective serotonin reuptake inhibitor (SSRI) drug class.

The investigation shows that, in the months before and after the three TV shows aired, the number of adverse event reports increased from 8.3 to 13.4 per 100,000 prescriptions. In contrast, the number of adverse event reports before and after the regulatory announcements changed from 7.6 to 8.0 reports per 100,000 prescriptions.

The initial Panorama program followed two announcements by the FDA. The first announcement, in January 2002, warned of severe withdrawal symptoms from paroxetine and the second, in October 2002, suggested links between the drug and suicidal behavior.

“Overall prescribing of paroxetine started to fall gradually after the FDA’s warning was publicized in the UK” said lead author Dr Richard Martin. “Prescribing patterns were not as obviously affected by media attention and regulatory announcements as the reporting of adverse drug reactions, but they may have helped to maintain the decline.”