Lotronex

The FDA has approved the marketing of Lotronex (alosetron hydrochloride) with restrictions, nearly two years after its manufacturer removed it from the market. Lotronex is the only medication proven effective in treating the symptoms of irritable bowel syndrome (IBS).

GlaxoSmithKline (GSK) of Research Triangle Park, N.C., voluntarily withdrew Lotronex in November 2000 after the FDA received reports of serious and life-threatening intestinal complications, including severe constipation and ischemic colitis. These conditions resulted in hospitalization, blood transfusions, surgery, and even death.

Lotronex slows the movement of stools through the bowels. It does not cure IBS and it will not help every person who takes it. For those with IBS who are helped, Lotronex reduces lower abdominal pain and discomfort, urgency to have a bowel movement, and diarrhea.

The FDA recognizes the need to carefully balance making effective therapies available with protecting the public from drug-related adverse events. As a result, the agency worked together with GSK to develop a Risk Management Plan (RMP) that allows market reintroduction of Lotronex, but only with limited access to women suffering with severe diarrhea-predominant IBS that is disabling.

This restricted marketing program ensures not only that patients and physicians are fully informed of the risks and benefits of Lotronex prior to using it, but also that only appropriate patients are prescribed the drug. The program enrolls only qualified physicians who agree to accept certain responsibilities.

The RMP brings together active participation by the doctor, the patient and the pharmacist. It includes the following components:

* GSK will establish a prescribing program for Lotronex to enroll physicians who plan to prescribe the drug.

* GSK will enroll physicians who agree to educate patients on the risks and benefits of Lotronex treatment, and to provide patients a copy of the FDA-approved Medication Guide.

* Patients will be asked to read and sign a Patient-Physician Agreement before receiving their initial prescription for Lotronex.

* Pharmacists will be asked to fill only prescriptions that display a prescribing program sticker affixed by an enrolled physician, and to give patients a copy of the FDA-approved Medication Guide every time they dispense the drug.

* Enrolled physicians will have agreed to report serious adverse events to GSK or to the FDA.

* GSK will conduct an ongoing assessment of the RMP, including a study of the prescribing and actual use of Lotronex.

The June 7 action follows an April 23, 2002, recommendation by the FDA's Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Subcommittee.

IBS is a disorder of the intestine that shows no sign of disease that can be seen or measured, but doctors know that the intestine isn't functioning normally. Abdominal pain, cramps, gas, bloating, diarrhea and constipation are among the symptoms.

Additional information on Lotronex, including the revised professional and patient labels and physician and patient agreement documents, can be found on the FDA's Web site at www.fda.gov/ cder/drug/infopage/lotronex/ lotronex.htm.

COPYRIGHT 2002 U.S. Government Printing Office
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