Withdrawn drugs "were approved by US FDA despite warnings from its experts"

A two-year Los Angeles Times investigation has concluded that, in itsapproval of seven drugs since 1993, the US Food and Drug Administration had disregarded "danger signs or blunt warnings from its own specialists." Each drug was later withdrawn, with the FDA last to withdraw several that were banned by European agencies. Adverse events reports listed the drugs as suspects in at least 1,002 deaths, notes the newspaper, adding that none was approved to treat life-threatening conditions and that the number of deaths could be even higher because AE reporting is voluntary.

The seven drugs specifically cited were: - Glaxo Wellcome's Lotronex (alosetron) for irritable bowel syndrome, approved despite an FDA medical officer's emphatic warnings. It was withdrawn after links to five deaths, the removal of a patient's colon and other bowel surgeries (Marketletter December 4, 2000); - American Home Products' diet pill Redux (dexfenfluramine), a suspect in 123 deaths (Marketletters passim), approved despite an advisory panel's vote against it; - Glaxo Wellcome's antibiotic Raxar (grepafloxacin), which may have caused fatal heart rhythm disruptions in clinical studies and is suspected in 13 deaths (Marketletter November 1, 1999); - Roche's blood pressure drug Posicor (mibefradil), approved despite FDA findings that it might fatally disrupt heart rhythm, and cited in 100 deaths (Marketletter June 15, 1998); - Johnson & Johnson's heartburn drug Propulsid (cisapride), cited in 302 fatalities and approved despite evidence it caused heart rhythm disorders (Marketletter April 3, 2000); - Warner-Lambert's diabetes drug Rezulin (troglitazone), approved over a medical officer's detailed opposition. It has been linked to 91 liver failures and a suspect in 391 deaths (Marketletter March 27, 2000); and - Wyeth-Ayerst's painkiller Duract (bromfenac sodium capsules) approved after FDA medical officers warned repeatedly of its liver toxicity. Senior officials sided with the maker in softening the label's warning of this threat, and it has been cited as a suspect in 68 deaths, 17 involving liver failure (Marketletter June 29, 1998).

Moreover, the report says, recent questionable decisions include Glaxo Wellcome's Relenza (zanamivir), approved after an FDA advisory committee concluded that the drug had not been proved safe and effective. The FDA later issued a "public health advisory" to doctors following the death of seven patients.