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Shelved drug in demand FDA to hear testimony on bowel syndrome

By Rita Rubin
USA TODAY

After receiving thousands of letters from desperate patients, the Food and Drug Administration will convene a panel of outside experts Tuesday to discuss whether Lotronex, an irritable bowel syndrome medication, can come back on the market.

''We really kept the light burning,'' says Jeffrey Roberts, an irritable bowel syndrome (IBS) patient who leads the Lotronex Action Group, which petitioned the FDA a year ago for the drug's return.

To meet demand, FDA official Victor Raczkowski says, his agency has expanded time allowed for public testimony at the advisory committee meeting from the usual hour -- often not filled -- to 1 hours.

IBS, affecting up to 15% of Americans, causes symptoms including lower abdominal pain, a sudden need to have a bowel movement, diarrhea and constipation. Lotronex was the first new IBS treatment in years and the only one approved for women who mainly have diarrhea, roughly one-sixth of all IBS patients.

Glaxo Wellcome, now GlaxoSmithKline, pulled Lotronex in November 2000, 8 months after the drug's debut. About 300,000 patients had taken it, according to Glaxo.

In June 2000, the FDA began receiving reports of Lotronex users suffering severe constipation and ischemic colitis, or inflammation of the large bowel, caused by reduced blood flow. By year's end, the FDA had learned of 141 such cases, including five deaths, according to the Public Citizen Health Research Group, which had petitioned the agency in August 2000 to withdraw the drug.

Sidney Wolfe, director of the Health Research Group, says he will present new Lotronex safety information at the FDA advisory committee meeting.

''We want it never to go back on the market again,'' Wolfe says. ''It should be limited only to people who had taken it before'' without ill effects.

Glaxo submitted new safety data to the FDA last December, says company spokeswoman Ramona DuBose.

DuBose say Glaxo and FDA officials have been meeting regularly since January 2001 to discuss ways of limiting adverse effects. DuBose would not discuss specifics, but others have said that possible steps include limiting prescribing to gastroenterologists and setting up a patient registry.

UCLA gastroenterologist Emeran Mayer, who was involved in studies of the drug, says doctors must be better educated about caring for their Lotronex patients. ''If symptoms get worse, I think this is the kind of drug where you should immediately stop it,'' he says, adding his clinic never saw a complication. ''If you don't give that information to patients, they just keep taking it.''

Glaxo marketed Lotronex too aggressively, leading to inappropriate prescribing, Mayer says. ''They really wanted to expand this as quickly as possible to all (IBS) patients. They clearly had this target: a billion-dollar drug. The only way you get to this is if a whole range of patients would use it.''

Roberts, 40, of Toronto, says his doctor didn't hesitate to give him Lotronex samples. Although he had some trepidation taking a drug approved only for women, Roberts says, he knew to stop taking it if he became constipated.

DuBose says it's against company policy to promote prescribing a drug for anything but its approved use. And, she says, if Lotronex were to return, accompanying restrictions would eliminate any chance that the drug would be ''commercially significant.''