FDA Panel, Amid Patients’ Pleas, Urges Clearing Lotronex for Sale

BETHESDA, Md. — Government advisors 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 follows 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 they fare.

“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 that it is too risky to sell again.

The syndrome afflicts up to 11% of Americans, mostly women. It isn’t life-threatening, but it can cause chronic abdominal pain, sudden and urgent need to use a toilet and either frequent diarrhea, constipation or both.