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Lotronex Tablets Withdrawn from Market

Reports of Adverse Effects, Including 5 Deaths

Nov 28, 2000 | SafetyAlerts Glaxo Wellcome has informed FDA that it will voluntarily withdraw Lotronex (alosetron hydrochloride) tablets from the market after reports of serious adverse events, which included 5 deaths.

Lotronex is a prescription medication approved to treat Irritable Bowel Syndrome(IBS) in women. The FDA is advising patients taking Lotronex to contact their healthcare providers to discuss treatment alternatives.

The company's action follows a meeting held earlier today with the Food and Drug Administration (FDA) where the agency discussed with Glaxo Wellcome risk management options that included restricting the distribution of the drug or marketing withdrawal. Today's action follows FDA analyses of the post-marketing reports of serious adverse events, which included 5 reports of death in patients taking Lotronex.

Specifically, FDA has been concerned about reported cases of intestinal damage resulting from reduced blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of severe constipation).

As of November 10, 2000, FDA had received and reviewed a total of 70 cases of serious post-marketing adverse events, including 49 cases of ischemic colitis and 21 cases of severe constipation. Of the 70 cases, 34 resulted in hospitalization without surgery, 10 resulted in surgical procedures, and three resulted in death. FDA has received two additional reports of death that the agency did not classify as being cases of ischemic colitis or severe complications of constipation.

FDA has been closely monitoring the drug since approval on February 9, 2000. Prior to approval, four cases of ischemic colitis were observed in clinical studies and were discussed at a November 1999 meeting of FDA's Gastrointestinal Drugs Advisory Committee. These cases were transient, mild-to-moderate in nature and reversible upon discontinuation of the drug.

Between approval and June 1, 2000, FDA received seven post-marketing reports of serious complications of constipation. This resulted in the hospitalization of six patients, three of whom required surgery. During the same time period, FDA received eight post-marketing reports of ischemic colitis. This resulted in four hospitalizations, four endoscopic procedures,
and no surgeries.

On June 27, 2000, FDA convened a public advisory committee meeting where risk management options in response to the serious adverse event reports were discussed. No deaths were reported up to that date. The consensus of the advisory committee members was that both physicians and patients must be informed of the potentially serious adverse events associated with Lotronex.

Following the meeting, FDA updated the healthcare professional labeling for Lotronex and required the drug's sponsor, Glaxo Wellcome, to distribute a Medication Guide that warned patients directly about the risks associated with the drug. In addition, at the request of FDA, Glaxo Wellcome issued "Dear Healthcare Professional" and "Dear Pharmacist" letters to advise these groups of the important new information.

FDA continued to receive severe adverse event reports of ischemic colitis and complications of constipation associated with Lotronex. In addition, FDA received reports of death and more serious complications of ischemic colitis that required blood transfusion or surgery.

Upon completing its recent analyses of the 70 cases, FDA's view of the options included marketing withdrawal or a restricted drug distribution program. The restricted drug distribution program would provide: (1) safe use of Lotronex in appropriately informed patients, (2) continued access to Lotronex by severely debilitated IBS patients under closely monitored conditions, and (3) continued clinical research into the benefits, risks, and safe and appropriate use of Lotronex. FDA recognized that the other available treatments for IBS may offer inadequate relief from a condition that can be severely incapacitating for some patients.

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