— The maker of a popular new treatment for women’s irritable bowel syndrome pulled the drug Lotronex off the market today after it was linked to a growing number of deaths and hospitalizations.
The withdrawal by Glaxo Wellcome Inc. comes just nine months after Lotronex began selling with great fanfare — and it becomes the seventh banned drug the increasingly embattled Food and Drug Administration has had to deal with in 2½ years.
Deadly Side Effects
The problem: Lotronex can cause severe side effects, including a life-threatening intestinal inflammation called ischemic colitis, and constipation so severe that some patients needed parts of their intestines surgically removed.
A review of FDA’s records by The Associated Press indicates the agency knows of at least eight women who died with intestinal side effects while taking Lotronex, a prescription drug. The agency also has 124 reports of Lotronex patients experiencing hospitalizations, disabilities or urgent medical treatments, and so far has classified 70 of those 124 cases as probably caused by the drug. Two-thirds of those women were sick enough to be hospitalized, the FDA 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 announced Tuesday that it would cease distribution of Lotronex immediately and recall the drug from pharmacies. About 150,000 people use Lotronex, and those who have supplies remaining can contact Glaxo about a refund at 1-888-825-5249.
The FDA says it offered Glaxo an alternative to yanking the drug from the market, but the company rejected that proposal.
Glaxo shares fell $2.31, or nearly 4 percent, close at $56.56 Tuesday on the New York Stock Exchange.
Lotronex initially was welcomed as the first new therapy in decades for irritable bowel syndrome, a mysterious disorder that affects up to 15 percent of Americans, mostly women. IBS is not life threatening but can cause misery. It involves chronic or recurrent abdominal pain, the sudden and urgent need to go to the bathroom and either frequent diarrhea, constipation or both.
Welcomed Initially, Then Dangerous
In studies, Lotronex offered only modest relief to women whose main IBS symptom was diarrhea. It did not work for men, and was declared downright dangerous for anyone with constipation.
The FDA warned the day it approved Lotronex last February that it might cause serious side effects because four women in clinical trials suffered ischemic colitis. But the agency approved the drug anyway, saying the mild cases healed once the women stopped taking Lotronex and that IBS sufferers needed a new option.
But within months, the FDA was receiving numerous reports of increasingly serious reactions. By August, it ordered Glaxo to attach special safety warnings to every bottle of Lotronex sold, urging doctors not to prescribe it to patients with constipation or other risk factors and telling women to stop using it at the first sign of trouble.
But just weeks later, FDA learned of the first death.
Still, however, FDA was reluctant to ban Lotronex because some doctors and patients insisted the drug greatly helped them. And Glaxo argued Lotronex could be used safely by the right patient: Among the first five deaths, for instance, four were women over age 65, 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 in their 30s and 40s.
FDA: Options Offered Company
Tuesday morning, FDA told Glaxo the agency wanted to keep Lotronex on the market but restrict sales to just a few women with severe IBS who are treated by specialists, said FDA’s Dr. Victor Raczkowski. Such restricted sales are used with the drugs thalidomide and Accutane, notorious for causing birth defects.
Kent called the option unworkable and said FDA’s response was then was to order Lotronex banned. Raczkowski denies that, calling the withdrawal of the drug Glaxo’s own decision.
Regardless, FDA should never have let Lotronex be sold, contends Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, which had urged the drug’s ban for months. Lotronex is not very effective, and FDA ignored early warning signs of trouble, first in clinical trials and then when hospitalizations began last spring, he said.
“Hopefully the FDA will learn something from this,” Wolfe said. “They’re saying, ‘Let’s bend over backwards and give the drug a chance.’ They wind up causing deaths and injuries that clearly would have been prevented” by stopping sales.