Recalled drug could see unprecedented return to market

Increased vigilance would be called for in supervising patients taking Lotronex for irritable bowel syndrome.

By Susan J. Landers, AMNews staff. June 3, 2002.

Washington -- The Food and Drug Administration and the manufacturer of a medication that was touted by many as the only effective treatment for irritable bowel syndrome are discussing whether the drug should be returned to the market after being recalled.

If alosetron hydrochloride, Lotronex, does become available after a safety recall it would be a first, said an FDA spokesman.

In February 2000, the agency initially approved Lotronex for use by women with IBS. (Clinical trials had included too few men to allow approval of the drug for men, but many were prescribed it off-label.)

However, the drug was voluntarily withdrawn by its manufacturer, Glaxo Wellcome, in November 2000, after numerous reports of serious adverse effects, including ischemic colitis and complications from constipation. Lotronex was thought to be the contributing cause in seven deaths, according to the FDA.

The drug's withdrawal prompted a major outcry by those for whom Lotronex had proven very effective, prompting the agency to take another look at the medication.

10% to 20% of adults have irritable bowel; women nearly twice as often as men.

As of mid-May the FDA was still negotiating with the manufacturer, now known as GlaxoSmithKline, on conditions agreeable to both that would allow for the drug's return to the market.

Following a joint public hearing, the FDA's Drug Safety and Risk Management Subcommittee and Gastrointestinal Drugs Advisory Committee recommended the drug be returned to the market with certain restrictions.

The committees advised prescribing the drug only to patients with the most severe symptoms and requiring that they receive counseling about the drug's potential risks.

Wide-reaching impact

The syndrome affects 10% to 20% of adults in this country and women are nearly twice as likely as men to have IBS. It is also most common among those 15 to 44 years old.

IBS prompts an estimated 3.5 million physician visits, 2.2 million drug prescriptions and 35,000 hospitalizations each year, according to the American Gastroenterological Assn.

It also accounts for 28% of all referrals to gastroenterologists, the association notes.

There is no agreement on a single cause for the syndrome, which can have as its predominant symptom either constipation or diarrhea.

Some physicians agree that the drug should be returned to the market as long as patients and physicians take the proper care in prescribing and using the medication.

"I think that for patients who were well-selected -- who had met the criteria for irritable bowel syndrome and had diarrhea predominance and were women -- there was a reasonable likelihood for a good response," said Ray Clouse, MD, professor of medicine and psychiatry at Washington University School of Medicine in St. Louis.

Dr. Clouse had prescribed Lotronex for some of his women patients.

Many of the traditional medications prescribed to treat IBS are low-risk but also low-efficacy drugs. They include antispasmodics, opiates and fiber supplements as well as tricyclic antidepressants.

"They are so low in efficacy that it has taken meta-analyses of many reports to come to the conclusion that they are effective. So you're dealing with medications that are marginally superior to placebo," said Dr. Clouse.

Jeffrey Roberts, president and founder of the Irritable Bowel Syndrome Self Help Group would agree. "I've suffered from IBS for 25 years, and nothing has been as effective as Lotronex."

But others believe the risks of taking the drug outweigh any benefits.

The agency watchdog group Public Citizen, for example, said that approval for remarketing the drug would constitute a "reckless" action by the FDA.

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Copyright 2002 American Medical Association. All rights reserved.



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