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

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

Robert Goldberg, vice president of the Center for Medicines in the Public Interest, writing on the group's blog, www.drugwonks.com, downplayed the reliability of the data, claiming it was produced by "well known industry and FDA critics." Citing the ISMP's report, Quarter Watch: 2008 Quarter 1, Dr Goldberg noted that "most drugs in medical use produced only a small number of reports of serious injury or death. One-half [of] the 773 identifiable drugs tracked in the most recent quarter had six or fewer serious adverse events reported. Only 50 drugs accounted for 100 or more reported serious injuries." He argued that these would be "the newest drugs, the ones that are most likely reported in the media in other words, or to be likely targets of law suits."