FDA advisory panels recommend Lotronex be put back on market

BMJ 2002; 324 doi: (Published 04 May 2002) Cite this as: BMJ 2002;324:1053
  1. Fred Charatan
  1. Florida

    Two advisory committees of the US Food and Drug Administration have jointly recommended that alosetron hydrochloride (Lotronex), voluntarily withdrawn in November 2000 by GlaxoSmithKline, should be put back on the market.

    It is the first time in the FDA's history that an advisory panel has recommended that a banned drug (BMJ 2000;321: 1429) should be reintroduced.

    GlaxoSmithKline said that it applied to the FDA for approval to allow the reintroduction of alosetron tablets under modified conditions of use, and with restrictions imposed by a risk management plan, for women with irritable bowel syndrome in which the predominant symptom is diarrhoea and in whom conventional treatment has failed.

    At a day long FDA hearing last month, panel members from the gastrointestinal drugs advisory committee and the newly formed drug safety and risk management subcommittee considered conditions for the reintroduction of alosetron.

    Eleven patients testified how they had benefited from the drug. William Brown, a lawyer, said that after experiencing irritablebowel syndrome for 40 years he was “almost totally cured” by alosetron. He urged the FDA to bring the drug back, but to require continuing education for doctors.

    Other lawyers representing patients who had experienced adverse effects from alosetron also addressed the panel about severe constipation as a known side effect of the drug. Some said they were considering a class action suit against the drug manufacturer.

    Dr Sidney Wolfe, director of Public Citizen's Health Research Group, said that a review of 27 randomised placebo controlled studies showed a large placebo response applicable to alosetron (Lancet 2000;356:2009).

    Since 31 December 2001, 352 admissions to hospital had been associated with the use of alosetron, most associated with gastrointestinal adverse reactions and including 85 cases of ischaemic colitis and 13 deaths (seven of which showed a “strong association with alosetron,” according to the FDA).

    Dr Wolfe concluded: “With the exception of some drugs used to treat cancer, the frequency and severity of a life threatening adverse reaction—in this case ischaemic colitis in patients using alosetron—is among the highest I have seen for any other drug.”

    It is not yet known whether the FDA will accept the panels' recommendations. A spokesman for GlaxoSmithKline, said: “Final details on the possible reintroduction of the medicine, and under what conditions, will be discussed by GSK and the FDA.”

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