http://bmj.com/cgi/content/full/325/7364/561
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 Collections under
which this article appears: Inflammatory
bowel disease Regulation
Adverse
drug reactions |
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 It was withdrawn nine months later after reports of serious side effects leading to admission to hospital, surgery, and death.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.)
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Collections under
which this article appears:Inflammatory
bowel disease Regulation
Adverse
drug reactions |
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