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11/30/2000

Alosetron Withdrawn from Market

Cheryl A. Thompson

Glaxo Wellcome withdrew alosetron from the U.S. market immediately after a November 28 meeting with the Food and Drug Administration (FDA) to discuss serious adverse events associated with the drug’s use.

In the nine months since FDA approved the marketing of alosetron, or Lotronex, for the treatment of diarrhea-predominant irritable bowel syndrome in women, the agency reviewed 70 reports of serious adverse events: 49 cases of intestinal damage caused by ischemic colitis and 21 cases of severely obstructed or ruptured bowels caused by severe constipation. Five people died while taking the drug. Two of these deaths, FDA determined, did not involve ischemic colitis or severe complications of constipation.

Concerns about serious events during alosetron use led to creation in June 2000 of an FDA-approved medication guide that pharmacists had to dispense with each Lotronex prescription. The medication guide warned patients about the risks associated with taking alosetron. Glaxo Wellcome sent letters to health care professionals, including pharmacists, advising them of the potential for patients to suffer serious adverse events while taking the drug.

Statements announcing the product’s withdrawal offered conflicting views of what transpired at the meeting. FDA said that it proposed "risk management options": withdraw the product or restrict its distribution. This restricted drug distribution program, FDA said, would provide safe use of Lotronex by appropriately informed patients; continued access, under closely monitored conditions, to the drug by patients severely debilitated by irritable bowel syndrome; and continued clinical research into the drug’s benefits, risks, and safe and appropriate use.

Glaxo Wellcome said it proposed further revision of the product’s labeling, restricted distribution, ongoing patient education, new clinical and epidemiological research, and use of an independent medical review board.

According to FDA, the company decided to voluntarily withdraw the product from the market. Glaxo Wellcome said it disagreed with FDA’s assessment of the safety profile of Lotronex and the ability to educate physicians and patients on how to manage potential adverse effects but voluntarily withdrew the product at the agency’s request.

Unless the company recalls the product, supplies can remain in pharmacies and be used to refill prescriptions, FDA said. The agency is telling patients to contact their pharmacist because many pharmacies may choose not to fill Lotronex prescriptions.

Glaxo Wellcome to Recall Lotronex from Pharmacies

1 December 2000—A Glaxo Wellcome spokeswoman said yesterday the company is sending a "Dear Pharmacist" letter requesting the return of Lotronex from pharmacies. The letter will include a self-addressed shipping label.

Wednesday, the company issued a "Dear Health Care Professional" letter regarding the product’s withdrawal from the U.S. market. The letter directs recipients to dispose of Lotronex samples "in the usual and customary way that you dispose of expired or damaged samples" or contact the company at 888-825-5249 to request postage-paid boxes for returning samples to the company.