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U.S. Department of Health and Human Services

Drugs

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Letter Regarding Lotronex from Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (12/18/2000)

The Food and Drug Administration (FDA) has received many letters about Glaxo Wellcome’s voluntary withdrawal of Lotronex (alosetron hydrochloride) tablets from the market.  I would like to thank all who have written to FDA for sharing their thoughts and concerns regarding this action.

Most letters have focused on the severity of some cases of irritable bowel syndrome (IBS) and the need for continued access to an effective treatment. I want to assure you that we at FDA are concerned about people suffering from IBS. We have heard from patients and health care professionals and are very aware that IBS can be a debilitating disease that greatly affects quality of life.

FDA worked closely with Glaxo Wellcome both before and after Lotronex’s approval on February 9, 2000, to evaluate adverse events reported with the use of the drug, and to develop ways to communicate the risks to health care professionals and patients. These included public discussions with FDA’s Gastrointestinal Drugs Advisory Committee, updating the professional labeling of Lotronex and the development of a Medication Guide for patients. You can find more details about these actions and additional information on the Lotronex Information Web Page.

After approval of Lotronex, FDA had to weigh the benefits experienced by many users of the drug against the serious adverse events experienced by others. This risk benefit evaluation was difficult because we were aware that many users of Lotronex did not experience these adverse effects. However, FDA’s view that unrestricted marketing of Lotronex poses a significant risk to patients was based on a review of the severity and types of reported adverse events. As of November 10, 2000, we had received numerous reports of serious adverse events, including 70 cases of:

  • ischemic colitis (intestinal damage resulting from reduced blood flow to the intestine),
  • severely obstructed or ruptured bowel (complications of severe constipation), and
  • death.

As we reviewed these reports, we discussed our concerns about patient safety with Glaxo Wellcome on numerous occasions. As a result of these discussions, FDA offered the option of a restricted distribution program to Glaxo Wellcome, as an alternative to marketing withdrawal. A restricted distribution program would have permitted the product to remain on the market under closely monitored conditions. The goals of a such a risk management program include:

  • safer use of Lotronex in appropriately informed patients
  • continued access to Lotronex by severely affected IBS patients under closely monitored conditions
  • continued clinical studies of the benefits and risks, and safe use of Lotronex.

After the discussions, Glaxo Wellcome chose to voluntarily withdraw Lotronex from the market. However, FDA is ready to work with Glaxo Wellcome, as with any sponsor, to develop risk management plans to ensure appropriate patient access to medically important, effective drugs.

Be assured that FDA is committed to working with pharmaceutical sponsors to facilitate the development and availability of treatment options for patients with IBS.

Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research