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A Comeback for Bowel Drug? A Comeback for Bowel Drug?
Mon Apr 22, 5:24 PM ET

By Lisa Richwine

WASHINGTON (Reuters) - Amid expected pleas from patients and warnings from a consumer group, a US advisory panel on Tuesday will debate whether GlaxoSmithKline Plc's irritable bowel drug Lotronex should be made available again.

The drug was pulled from the market in November 2000 over safety concerns. Since then, thousands of patients have lobbied for access to Lotronex, saying it dramatically improved their lives.

Some patients will appear before Tuesday's meeting of a US Food and Drug Administration (news - web sites) (FDA) advisory panel. Also testifying will be Public Citizen, a consumer group that says Lotronex offers unacceptable risks for a condition that is not life-threatening.

The panel, which also will hear from FDA reviewers and GlaxoSmithKline, is expected to offer advice on whether Lotronex should be made available with restrictions to minimize side effects. The FDA usually follows its panels' advice.

Irritable bowel syndrome (IBS) afflicts millions of Americans, mostly women, with a variety of symptoms that include diarrhea, constipation and abdominal pain. Lotronex was approved for treating women whose main symptom is diarrhea.

For some patients, IBS can be debilitating. With Lotronex, symptoms stopped completely, some said.

But soon after its March 2000 launch, regulators started receiving reports of Lotronex patients who experienced ischemic colitis, a serious condition that restricts blood flow to the colon, and severe constipation. When the drug was pulled from the market in November 2000, the FDA said three deaths possibly were related to Lotronex.

GlaxoSmithKline will present a plan that aims to educate physicians about which patients should receive Lotronex and to help patients recognize potential side effects so they can seek medical help, company spokeswoman Ramona DuBose said.

Public Citizen, which has pressed the FDA to keep the drug off the market, has argued that it is impossible to predict which patients are at risk for serious complications.

Past Lotronex users are desperate for the drug, said Jeffrey Roberts, a patient who founded the IBS Self Help Group. A survey by the group found that nearly all were willing to sign a consent form outlining risks of Lotronex, and a majority said they would participate in a side-effect survey.

"IBS sufferers are prepared to accept risks related to the use of Lotronex and other effective treatments," Roberts said in a statement prepared for the meeting.

Lotronex was once touted as a blockbuster drug, but London-based GlaxoSmithKline has cautioned that a comeback for the drug would be limited and not commercially significant.

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