FDA Warns Women About New Drug

W A S H I N G T O N, Aug. 25, 2000 -- 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.

Lotronex is the first new therapy in decades for irritable bowelsyndrome, a mysterious disorder that affects up to 15 percent ofAmericans, mostly women. IBS involves chronic or recurrentabdominal pain, the sudden and urgent need to go to the bathroomand either frequent diarrhea or constipation or both.

Lotronex offers modest relief to women whose main IBS problem isdiarrhea. It doesn’t work for men.

About one of every 700 Lotronex users will develop ischemiccolitis, says the new MedGuide. Also, the drug can causeconstipation so severe that patients need hospitalization, evensurgery, to unblock their intestines. In the worst case, onepatient needed her colon removed.

The FDA’s top warnings:

— Do not ever take Lotronex if you are constipated most of thetime or ever have had severe constipation. If you have severe orworsening constipation while taking Lotronex, stop using itimmediately and call your doctor.

— Stop using Lotronex and call your doctor immediately if youhave new or worsening pain in the lower abdomen, bloody diarrhea orblood in the stool. These are early symptoms of ischemic colitis.

— Because Lotronex does not cure IBS or work for everyone, quitusing it if your symptoms do not improve within four weeks.

— Do not take Lotronex if you have ever had ischemic colitis orsuch other intestinal disorders as Crohn’s disease, ulcerativecolitis or active diverticulitis.