Glaxo Removes Lotronex From Market

ByABC News
November 28, 2000, 5:10 PM

W A S H I N G T O N, Nov. 28 -- The maker of a popular new treatment forwomens irritable bowel syndrome pulled the drug Lotronex off themarket today after it was linked to a growing number of deathsand hospitalizations.

The withdrawal by Glaxo Wellcome Inc. comes just nine monthsafter Lotronex began selling with great fanfare and it becomesthe seventh banned drug the increasingly embattled Food and DrugAdministration has had to deal with in 2½ years.

Deadly Side Effects

The problem: Lotronex can cause severe side effects, including alife-threatening intestinal inflammation called ischemic colitis,and constipation so severe that some patients needed parts of theirintestines surgically removed.

A review of FDAs records by The Associated Press indicates theagency knows of at least eight women who died with intestinal sideeffects while taking Lotronex, a prescription drug. The agency alsohas 124 reports of Lotronex patients experiencing hospitalizations,disabilities or urgent medical treatments, and so far hasclassified 70 of those 124 cases as probably caused by the drug.Two-thirds of those women were sick enough to be hospitalized, theFDA says.

Company: FDA Ordered the Action

Glaxo contends Lotronex is safe when used by the right patient,and calls it no more risky than some other big-selling medicines.But, saying it was under orders from FDA, the company announcedTuesday that it would cease distribution of Lotronex immediatelyand recall the drug from pharmacies. About 150,000 people useLotronex, and those who have supplies remaining can contact Glaxoabout a refund at 1-888-825-5249.

The FDA says it offered Glaxo an alternative to yanking the drugfrom the market, but the company rejected that proposal.

Glaxo shares fell $2.31, or nearly 4 percent, close at $56.56Tuesday on the New York Stock Exchange.

Lotronex initially was welcomed as the first new therapy indecades for irritable bowel syndrome, a mysterious disorder thataffects up to 15 percent of Americans, mostly women. IBS is notlife threatening but can cause misery. It involves chronic orrecurrent abdominal pain, the sudden and urgent need to go to thebathroom and either frequent diarrhea, constipation or both.