US data finds 38% rise in serious AE reports to FDA; Chantix claims disputed

3 November 2008

US data compiled by the Pennsylvania-located Institute for Safe Medication Practices, which was based on Food and Drug Administration figures, suggests that the number of serious adverse events associated with drugs has rocketed 38% to 20,745 in the first quarter of 2008, with 4,825 deaths, a threefold increase on the previous year's quarterly average. The news was widely reported in the US media, with the focus firmly placed on global pharmaceutical behemoth Pfizer's Chantix/Champix (varenicline), although heparin was also mentioned.

High-media profile and law-suit-potential drugs get reported

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