W A S H I N G T O N, Nov. 28, 2000 -- — The maker of a popular new treatment forwomen’s 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 FDA’s 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.
Welcomed Initially, Then Dangerous
In studies, Lotronex offered only modest relief to women whosemain IBS symptom was diarrhea. It did not work for men, and wasdeclared downright dangerous for anyone with constipation.
The FDA warned the day it approved Lotronex last February thatit might cause serious side effects because four women in clinicaltrials suffered ischemic colitis. But the agency approved the druganyway, saying the mild cases healed once the women stopped takingLotronex and that IBS sufferers needed a new option.
But within months, the FDA was receiving numerous reports ofincreasingly serious reactions. By August, it ordered Glaxo toattach special safety warnings to every bottle of Lotronex sold,urging doctors not to prescribe it to patients with constipation orother risk factors and telling women to stop using it at the firstsign of trouble.
But just weeks later, FDA learned of the first death.
Still, however, FDA was reluctant to ban Lotronex because somedoctors and patients insisted the drug greatly helped them. AndGlaxo argued Lotronex could be used safely by the right patient:Among the first five deaths, for instance, four were women over age65, suggesting that it should not be prescribed to older women,said Dr. Richard Kent, Glaxo’s chief medical officer.
Critics counter, however, that many women hospitalized were intheir 30s and 40s.
FDA: Options Offered Company
Tuesday morning, FDA told Glaxo the agency wanted to keepLotronex on the market but restrict sales to just a few women withsevere IBS who are treated by specialists, said FDA’s Dr. VictorRaczkowski. Such restricted sales are used with the drugsthalidomide and Accutane, notorious for causing birth defects.
Kent called the option unworkable and said FDA’s response wasthen was to order Lotronex banned. Raczkowski denies that, callingthe withdrawal of the drug Glaxo’s own decision.
Regardless, FDA should never have let Lotronex be sold, contendsDr. Sidney Wolfe of the consumer advocacy group Public Citizen,which had urged the drug’s ban for months. Lotronex is not veryeffective, and FDA ignored early warning signs of trouble, first inclinical trials and then when hospitalizations began last spring,he said.
“Hopefully the FDA will learn something from this,” Wolfesaid. “They’re saying, ‘Let’s bend over backwards and give thedrug a chance.’ They wind up causing deaths and injuries thatclearly would have been prevented” by stopping sales.