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Collections under which this article appears: Inflammatory bowel disease Regulation Adverse drug reactions

BMJ 2002;325:561 ( 14 September )

News

FDA advisers warn of more deaths if drug is relaunched

Ray Moynihan, Washington, DC

Advisers to the US Food and Drug Administration are warning of more serious injuries and drug related deaths if alosetron (Lotronex)a drug for bowel disorders manufactured by GlaxoSmithKlinereturns to the market later this year.

Once considered a potentially top selling drug, it was first approved in February 2000 for women with "diarrhoea- predominant" irritable bowel syndrome. It was withdrawn nine months later after reports of serious side effects leading to admission to hospital, surgery, and death.

Urged by patient groups, the FDA and the manufacturer worked together to bring alosetron back to the market, and in April this year a special FDA advisory committee meeting recommended re-approval, based on a "risk management" programme. One of the key conditions of that programme, debated at the meeting and supported by a majority of committee members, was that physicians should be specially trained and certified before they could prescribe alosetron.

However, when the FDA formally announced approval six weeks later, that key condition was ignored in favour of a less restrictive plan to allow doctors to prescribe the drug if they personally attested that they were qualified to do so.

Dr Brian Strom, an FDA advisory committee member and professor of biostatistics and epidemiology at the University of Pennsylvania, says the current risk management programme for alosetron risks becoming a "facade," which "may make commercial sense to the company, but not public health sense. The risk-benefit ratio is not worth it, unless the use can be restricted to those who really need it and who are likely to benefit from itwhich is a very, very small group."

Dr Peter Gross, chairman of the department of internal medicine at Hackensack University Medical Center, New Jersey, says: "The main reason for concern is that this is a drug that has caused fatalitieswithout much of a warning signal." Despite his concerns, Dr Gross believes the advisory committee's elaborate proposals for certification may have been too idealistic, and he congratulated FDA staff on their handling of the drug.

A third committee member, Dr Mike Cohen from the Institute of Safe Medication Practices in Huntingdon Valley, Pennsylvania, warned that there may be "the same kind of problems in terms of adverse events as we had before, and the drug might have to be withdrawn again." The public statements are the latest in a series of controversies surrounding the drug; the US consumer group Public Citizen had wanted it withdrawn within months of its initial release.

Director of the FDA's Center for Drug Evaluation and Research, Dr Janet Woodcock, defended the decision on prescriber eligibility, saying, "we had to address risk without placing an unnecessary burden on everyone." Asked about the FDA ignoring a key recommendation from its advisers, a spokesperson for GlaxoSmithKline said the committee did not vote on that specific issue.

The concerns come as a former senior consultant with the FDA, Dr Paul Stolley, who was involved in the post-marketing surveillance of alosetron, claims that the FDA has become a "servant of the industry, where dissenting voices are intimidated and ostracised and where scientific debate is repressed." (See Education and debate, p 592; editorial, p 555.)

© BMJ 2002
 

PDF of this article Email this article to a friend Respond to this article Related editorials in BMJ Other related articles in BMJ PubMed citation Related articles in PubMed Download to Citation Manager Search Medline for articles by: Moynihan, R. Alert me when: New articles cite this article

Collections under which this article appears: Inflammatory bowel disease Regulation Adverse drug reactions

This article has been cited by other articles:

• Moynihan, R. (2002). Alosetron: a case study in regulatory capture, or a victory for patients' rights?. BMJ 325: 592-595 [Full text]  

Related editorials in BMJ:

Alosetron for irritable bowel syndrome .

Michel Lièvre
BMJ 2002 325: 555-556. [Full text]  

 

Other related articles in BMJ:

EDUCATION AND DEBATE
Alosetron: a case study in regulatory capture, or a victory for patients' rights?.

Ray Moynihan
BMJ 2002 325: 592-595. [Full text]  

 

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