The Pharmaceutical Journal
Vol 269 No 7216 p387
21 September 2002

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BMJ (bmj.com)
United States Food and Drug Administration (www.fda.gov)

FDA criticised for alosetron ruling

The United States Food and Drug Administration has been criticised by its own advisers for allowing the reintroduction of alosetron (Lotronex).

Alosetron was withdrawn from the US market by manufacturers GlaxoSmithKline nine months after its launch following reports of serious side effects and deaths (PJ, 2 December 2000, p809).

However, in June this year, the FDA issued a new supplemental drug application following calls for its reintroduction from patient groups. This allows alosetron to be prescribed on a named-patient basis to women with diarrhoea-predominant irritable bowel syndrome, as long as the prescribing doctor is qualified to do so.

Last week, FDA advisers expressed concerns that the drug would cause more adverse events and deaths if reintroduced and said such a move did not make public health sense. And, in an editorial in last week's BMJ (2002;325:555), Professor Michel Lièvre of the clinical pharmacology unit of Lyons University, suggests that lobbying by the pharmaceutical industry could have helped change the FDA's mind. He concludes that the FDA has failed in its mission to protect public health through ensuring that human drugs are safe and effective.