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Controversial Bowel Drug Makes Limited Comeback Controversial Bowel Drug Makes Limited Comeback
Fri Jun 7,11:56 PM ET

By Adam Marcus
HealthScoutNews Reporter

FRIDAY, June 7 (HealthScoutNews) -- The Food and Drug Administration (news - web sites) today gave a guarded second chance to the controversial bowel drug Lotronex, which was pulled in 2000 after being linked to a handful of deaths.

Officials said they would allow GlaxoSmithKline, which makes Lotronex, to offer the drug under strict oversight to a select group of women with severe irritable bowel syndrome marked by diarrhea and who have failed to respond to other treatments. It is the first time a drug that was pulled for safety reasons was re-introduced.

An estimated 18.5 million American million women have irritable bowel syndrome (IBS), but only a few percent would qualify for the therapy, said Dr. Joyce Korvick, an FDA scientist.

To prescribe the drug, doctors will have to notify the company that they're familiar with its risks and the bowel condition and will receive stickers in return. Pharmacies will be discouraged from filling prescriptions without first seeing a sticker.

Lotronex will also carry a "black box" warning, the agency's most stringent caution, and GlaxoSmithKline has said it will not market the drug directly to consumers. Officials said doctors could offer the drug to men with IBS, although it is not specifically approved for them.

Lotronex was initially approved in February 2000 but GlaxoSmithKline voluntarily pulled it nine months later after reports of severe constipation and bowel damage associated with the drug. As of March 2002, the FDA said, it had reports of 84 cases of bowel damage and 113 cases of serious constipation linked to the pill, 137 of which required hospitalization. At least four, and possibly several more, proved fatal.

At the time, the decision to withdraw the drug was hailed by some consumer advocates. But patients with severe IBS protested, saying the drug was the only effective treatment for their ailment.

Dr. Florence Houn, an FDA official familiar with the reinstatement, said it was with precisely these people in mind that the agency agreed to give the drug a new life. "They are the ones who are desperate and suffering the most," she said.

Lotronex becomes the fifth drug to be approved under a restricted marketing system, which also cover such therapies as thalidomide and Mifeprex, the abortion pill. It is the first to be pulled for safety reasons and later reintroduced, according to the FDA. In the 1950s and 1960s, about 10,000 children worldwide suffered birth defects after their mothers took thalidomide to treat morning sickness. The drug -- never approved for use in the United States -- was banned in 1962.

Dr. Eric Carter, a GlaxoSmithKline official in charge of Lotronex, said the company would begin selling the drug in "several" months, once it works out the details of its risk management plan with the FDA. The firm, in Research Triangle Park, N.C., is not currently making Lotronex tablets so it must restart the production process.

Carter said the company is "satisfied" with the terms of its drug's return. Yet, he's worried that some doctors might find the registration component too complicated and bothersome. Ideally, he said, both gut specialists and generalists would apply to prescribe the pill.

Jeffrey Roberts, president and founder of the IBS Self Help Group, an online site for patients with the condition, applauded today's decision on Lotronex. However, Roberts said he considered the sticker system "onerous" and hoped the agency would ease the restrictions if the drug proves safe.

Roberts called the initial withdrawal of the drug a "catastrophic mistake" for people with severe IBS, who could get no relief from other therapies in its absence. The various safety nets now in place to educate patients about its risks, including printed materials, labeling and consultations with doctors, should be sufficient protection, he added.

But Public Citizen, the consumer watchdog group that led the effort to withdraw Lotronex, said its reintroduction will "endanger" patients. "Not only is the new marketing program too lax to prevent harm, but it is to be overseen by the company that makes the drug -- a poor idea because the company has a financial incentive to downplay problems with the drug," the group says in a statement.

What To Do

For more on Lotronex and its return, try the Food and Drug Administration.

To learn more about irritable bowel syndrome, try the National Institutes of Health or the IBS Self Help Group.

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