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FDA Seeks Comments on IBS Drug


WebMD Health News

Jan. 25, 2002 -- In response to repeated requests from people with irritable bowel syndrome (IBS), the FDA is now re-examining the status of the controversial drug Lotronex.

According to a letter sent to patients by the FDA's Division of Drug Information, a tentative meeting has been set for April 22 to hear comments from an FDA advisory committee and the public about the drug.

The FDA approved Lotronex in February 2000 to treat specific types of the intestinal illness, but it was withdrawn from the market nine months later after several life-threatening reactions and at least five deaths occurred in people given the drug.

Lotronex was the first new drug in years to be approved to treat IBS, and its popularity quickly soared among people with the often-debilitating disease. Nearly half a million prescriptions were given during its brief availability.

Since it was taken off the market, the drug's manufacturer, GlaxoSmithKline, has been in discussions with the FDA. They are exploring ways to create safety measures to ensure Lotronex is used only by people in whom the benefits would exceed the risks, the letter says.

The FDA's letter states that IBS patients have commented that the agency is applying a different set of review standards in considering the risks and benefits for treatments for IBS -- an allegation denied in the letter.

"There is little data currently available regarding specific risk factors, how patients can recognize emerging serious adverse events, or how Lotronex can be used to avoid or alleviate these risks. Under these circumstances, all IBS patients treated with Lotronex must be considered at risk for serious adverse events," write the authors.

The FDA says the IBS community will have a voice in considering the risks and benefits of the drug, and it will include an IBS patient on the advisory committee.

If you have additional questions about Lotronex or other drugs, call the FDA's Division of Drug Information at (888) INFO-FDA or email druginfo@cder.fda.gov.

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