FDA Warns Women About New Drug

W A S H I N G T O N, Aug. 25 -- A popular new treatment for irritable bowelsyndrome could cause severe intestinal side effects — somerequiring surgery — that have already affected at least 19 women.

The Food and Drug Administration announced Thursday it hadordered Glaxo Wellcome Inc. to attach to every bottle of Lotronex aplain-English pamphlet explaining the risk, and that women shouldstop taking it at the earliest sign of a problem.

Women have reported either a potentially life-threateningintestinal inflammation called ischemic colitis or severeconstipation, and the FDA has preliminary reports of another 14cases since Lotronex hit the market six months ago.

Some cases apparently were caused by doctors giving Lotronex towomen who shouldn’t have taken it, sparking the FDA to order theunprecedented straight-to-the-patient warning brochures called“MedGuides.”

A Spate of Banned Drugs

The FDA, shaken by a recent spate of drugs that had to bebanned, is hunting for new ways to swiftly counter side effects ofnewly approved prescription drugs. Lotronex will test whether theMedGuides help.

A consumer advocacy group, however, called the moveinsufficient.

“We do think this drug should come off the market, and willfile a petition to get it off,” said Dr. Sidney Wolfe of the groupPublic Citizen, who said he fears a woman eventually will die ofthe side effects. “The risks clearly outweigh the benefits.”

But the FDA counters that if patients learn the early signs of aside effect, they can stop taking Lotronex before they havetrouble.

“This drug works in some people and it doesn’t work inothers,” said Dr. Victor Raczkowski, FDA’s deputy chief ofgastrointestinal drugs. The new warning should ensure that “thepatients most likely to benefit from the drug and least likely tohave serious side effects take it.”

Glaxo Mailing Warnings

Glaxo also is mailing a warning to thousands of doctors thisweek to help reduce the number of prescriptions physicians areimproperly writing for women who shouldn’t use the drug, said vicepresident James Palmer.