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Pulled Bowel Drug Back on Market with Limits Pulled Bowel Drug Back on Market with Limits
Fri Jun 7, 6:23 PM ET

By Lisa Richwine

WASHINGTON (Reuters) - U.S. health officials on Friday responded to pleas from patients and allowed irritable bowel treatment Lotronex back on the market with restrictions, the first comeback for a drug pulled for safety reasons.

Maker GlaxoSmithKline Plc withdrew Lotronex in November 2000 after some patients who took it experienced severe intestinal problems, including some that were deadly. But irritable bowel sufferers clamored for its return, saying Lotronex dramatically eased their debilitating symptoms.

The Food and Drug Administration (news - web sites) said it cleared the re-introduction to give seriously ill patients access to the treatment. The agency set several conditions to limit use and ensure that patients are aware of the pill's risks.

A consumer group said the steps were inadequate to prevent further harm.

The FDA narrowed the drug's approved use to include only women with severe irritable bowel syndrome whose main symptom is diarrhea and who have not responded to conventional therapy.

"The goal is to limit the use to patients who stand to benefit most from the drug," said Dr. Victor Raczkowski, acting director of the FDA's division that reviewed Lotronex.

GlaxoSmithKline will establish a program for physicians who state they are qualified to prescribe the drug and agree to educate patients about its risks. The physicians must agree to report any serious problems in Lotronex patients. Pharmacists will be asked to fill prescriptions only if they display a sticker attached by a physician enrolled in the program, the FDA said.

Patients will be asked to sign a form acknowledging that they have discussed Lotronex's risks and benefits with their doctors.

The Lotronex label will state that the drug has not been shown safe or effective for men, but doctors will be able to decide which patients are candidates for the drug, Raczkowski said.

Consumer group Public Citizen said the program was too lenient, saying that no one is required to check prescribers' qualifications or whether patients were informed of risks.

"The FDA's action will almost surely lead to more injuries and possibly deaths associated with this drug," said Larry Sasich, a pharmacist who works for the group.

Jeffrey Roberts, a patient who led a campaign to bring Lotronex back, said he was pleased the drug was returning but added that he hoped some restrictions would be eased over time.

Patients "can now breathe a sigh of relief in terms of access, albeit restricted, to a medicine that gave many back their day-to-day lives," Roberts said.

GlaxoSmithKline Vice President Eric Carter said Lotronex would not be available for several months. The company needs time to resume manufacturing and put the new restrictions in place, he said.

As of March 8, the FDA had received reports of 84 cases of ischemic colitis, a serious condition that restricts blood flow to the colon, and 113 cases of serious constipation in patients who took Lotronex. Four patients died, and others were hospitalized or required surgery, an FDA statement said.

About 275,000 patients took Lotronex before its recall.

Irritable bowel syndrome causes alternating bouts of diarrhea and constipation as well as severe abdominal pain and in some cases incontinence. The FDA said less than 5 percent of irritable bowel cases are considered severe.

London-based GlaxoSmithKline does not expect the Lotronex comeback to significantly impact the firm financially because the drug's use will be limited, Carter said.

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