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FDA Panel Signs Off On Bowel Drug

Government advisers heeded patients' pleas Tuesday that a drug for irritable bowel syndrome should be cleared for sale again — but with stringent restrictions to try to mitigate side effects that have hospitalized more than 160 people and killed seven.

If the Food and Drug Administration accepts the panel's advice, Lotronex will be tough to get — prescribed only by doctors who have undergone special training to use it and given only to the sickest patients, who must register in a national database that monitors how well they fare.

To patients who called the drug a miracle therapy, that's enough.

"A life without Lotronex is a miserable existence," said a tearful Diana Hoyt of Atlanta, who described swallowing four anti-diarrheal pills and donning a diaper just to spend a few minutes asking the FDA for the only pill that ever made her feel well.

Two attorneys for people injured by the once-popular drug, which was pulled off the market in November 2000, argued it's too risky to sell again. One played a video of a Florida woman left mostly paralyzed and unable to breathe on her own after a burst colon attributed to Lotronex caused a brain-damaging infection.

Her attorney asked if the FDA should allow the sale of Lotronex again.

"No, don't let them," Gloria Lockett gasped on the videotape.

"She would have been better off dead," attorney Dennis Larry said later.

The risk is worth it, responded 10 sufferers of irritable bowel syndrome. "Have you ever soiled your pants in public?" Brenda Compton snapped at one of the attorneys. She turned to face the panel of solemn-faced physicians judging the issue for FDA. "I'm not asking you, I'm begging you, bring the drug back."

Lotronex initially was lauded as the first new therapy in decades for irritable bowel syndrome, or IBS, which afflicts up to 11 percent of Americans, mostly women. The illness isn't life-threatening, but causes misery: chronic abdominal pain, sudden and urgent need to go to the bathroom and either frequent diarrhea, constipation or both. Lotronex is only for the diarrhea-dominant type.

After only nine months of sales in 2000, manufacturer GlaxoSmithKline pulled Lotronex off the market because of two side effects: a life-threatening intestinal inflammation called ischemic colitis and constipation so severe it could require surgery, even kill.

The FDA has counted 238 reports of those side effects. Some 163 were hospitalized and 51 required surgery. Of 14 reported deaths, seven were probably caused by the drug, FDA says.

In studies, Lotronex offered only modest overall relief for female IBS patients. But the most severely ill — estimated at 5 percent to 10 percent of IBS patients — seemed to benefit far more. It's not proved to work for men and is dangerous for anyone with constipation.

"It is our intention to be extremely cautious with this medication," said Glaxo's Dr. James Palmer.

Glaxo's plan: Only physicians experienced in treating IBS could prescribe Lotronex; women would have to sign a form swearing they understand the risks; and pharmacists could fill only prescriptions bearing a special sticker showing that the form had been signed.

Patients could only get a 30-day supply at a time — no refills without another doctor's visit — and would be told to try 1 milligram daily, half the originally recommended dose. They would be urged to see a doctor immediately if they have any symptoms of side effects, such as constipation, unusual abdominal pain or blood in the stool.

FDA's advisers recommended some additional restrictions, stressing that the drug is only for the sickest patients, who must register on a national database to get the drug, and that physicians undergo some form of training to prescribe Lotronex instead of simply declaring themselves competent to do so. Glaxo also must perform audits or other tough monitoring to ensure the restrictions are working.

The FDA isn't bound by its advisers' recommendations but typically follows them.

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