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April 23, 2002

U.S. Agency May Allow the Selling of Diarrhea Drug Linked to Deaths



Food and Drug Administration
Drugs (Pharmaceuticals)
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In an unusual action, Food and Drug Administration officials will meet today to consider whether Lotronex, a drug withdrawn for safety reasons in November 2000, should be allowed back on the market with new restrictions to protect patients.

Lotronex, approved in February 2000 to treat chronic diarrhea caused by irritable bowel syndrome, was taken off the market less than 10 months later. About 275,000 people had used it, and it was linked to five deaths and serious intestinal problems in about 200 patients.

But after Lotronex was withdrawn, the food and drug agency said, it received "an unprecedented number of communications" from doctors, patients and patient advocacy groups who wanted the drug back. Many patients said they were desperate because nothing else worked for them.

Irritable bowel syndrome is not life-threatening, but some patients suffer from such severe attacks of diarrhea that they cannot leave the house. Even though Lotronex had been approved only for women, on the basis of studies that found a benefit only in women, many men had used the drug as well and wanted access to it.

Lotronex will be the first drug considered by a new food and drug agency group, the Subcommittee on Drug Safety and Risk Management, which was created in December to provide expert advice on drugs like Lotronex that pose especially complex risk-benefit questions. Lotronex was one of 11 drugs taken off the market because of adverse effects since 1997.

The session today will be a joint meeting of the new subcommittee and the food and drug agency's Gastrointestinal Drug Advisory Committee. The maker of Lotronex, GlaxoSmithKline, will present new data on the drug and a plan to market it with new safeguards. Officials will also hear presentations from the food and drug agency's scientists and from patients and advocacy groups for and against allowing the drug to be sold again.

After the presentations, the two food and drug agency groups will vote on whether the manufacturer's new marketing plan should be accepted. Their findings will then be presented to the full Food and Drug Administration, which usually follows the advice of its advisory panels.

The problem with Lotronex is that it causes an increased risk of two potentially serious conditions: severe constipation and ischemic colitis, in which circulation to the bowel is cut off. Both conditions can resolve on their own once the drug is stopped, but in some cases they can require major surgery to remove part of the intestine. Both can be fatal.

Under the company's proposed "risk management plan," Lotronex would be recommended only for women for whom other treatments had failed to control diarrhea caused by irritable bowel syndrome. Its starting dose would be cut in half, to 1 milligram a day, and the pill bottles would have information pamphlets attached. Doctors would have to request "prescribing kits" that would be delivered by company representatives who would discuss the drug.

Doctors and patients would have to sign statements saying they had reviewed the risks and knew symptoms the danger signs, including constipation, new or worsening abdominal pain, bloody diarrhea or blood in the stool. Doctors would not be allowed to prescribe more than a 30-day supply, and pharmacies would be permitted to fill only written prescriptions carrying a sticker from the prescribing kit.

"It's a pretty rigorous program, but I think people will follow it," said Ramona Dubose, a spokeswoman for GlaxoSmithKline. She said it was not clear whether doctors could continue to prescribe the drug for men as they had in the past.

Dr. Sidney Wolfe, director of a patient advocacy group in Washington, the Public Citizen Health Research Group, said, "I think it's just asking for trouble to put it back on market. Inevitably it will come off, and we will have more people with ischemic colitis and some will die."

Dr. Wolfe's group had petitioned the food and drug agency to take Lotronex off the market months before the agency did so. If Lotronex is brought back at all, Dr. Wolfe said, it should be as a tightly controlled experimental drug that could be used only with close monitoring in studies.

But some patients disagree. One, who will speak at the meeting today, is Jeffrey Roberts, who works in the brokerage industry and who has founded several self-help groups for patients. Mr. Roberts said, "We think the F.D.A. is learning that quality-of-life issues are very significant, rather than just curing an illness, and people are willing to accept some level of risk in order to have a better quality of life."

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