(2002; 91 pages)
Alosetron hydrochloride: restricted marketing
United States of America - The Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) that permits marketing of alosetron hydrochloride (Lotronex®) with restrictions. The manufacturer of the drug will be implementing a risk management and prescribing pro-gramme for physicians who wish to prescribe alosetron. The drug’s indication has been narrowed to treatment of women with severe, diarrhoea-predominant irritable bowel syndrome (IBS) who have failed to respond to conventional IBS therapy. Limiting the use of alosetron to this severely affected population is intended to maximize the benefit to risk ratio.
Serious and unpredictable gastrointestinal adverse events, including some that resulted in death, have been reported in association with alosetron use. Less than 5% of IBS is considered severe, and only a fraction of severe cases are diarrhoea-predominant IBS. Severe IBS is a chronic condition (in this case, generally lasting more than six months) with symptoms that disable or significantly curtail the daily activities of patients.
The risk management programme is designed to help ensure that patients and physicians are fully informed of the risks and benefits and that only appropriate patients are prescribed the drug. Action follows a recommendation by FDA’s Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Subcommittee of the Advisory Committee for Pharmaceutical Science.
FDA first approved alosetron in February 2000. The manufacturer voluntarily withdrew alosetron hydrochloride from the market in November 2000.
Reference: http://www.fda.gov/cder/drug/infopage/ lotronex/lotronex.htm.