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Deaths Prompt Probe of Bowel Drug

Updated:
By LAURAN NEERGAARD
AP Medical Writer

WASHINGTON (AP) — Five women reportedly died after using a popular new treatment for irritable bowel syndrome that can cause severe intestinal side effects, Food and Drug Administration records show.

FDA officials cautioned that it's too early to know if the drug Lotronex was to blame, or if other illnesses contributed to or caused those deaths. But the agency is investigating Lotronex's safety, even as a consumer advocate renewed calls Monday for the drug to be banned.

Lotronex is the first new therapy in decades for irritable bowel syndrome, a mysterious disorder that affects up to 15 percent of Americans, mostly women. IBS involves chronic or recurrent abdominal pain, the sudden and urgent need to go to the bathroom and either frequent diarrhea, constipation or both.

Lotronex offers modest relief to women whose main IBS problem is diarrhea. It doesn't work for men.

The FDA has repeatedly warned women and their doctors that Lotronex can cause some serious side effects: a potentially life-threatening intestinal inflammation called ischemic colitis, and constipation so severe that some patients have needed surgery to unblock their intestines. Consequently, Lotronex is never supposed to be taken by women who are constipated or have had severe constipation or certain other intestinal disorders in the past.

Just last August, the FDA gave the unprecedented order that manufacturer Glaxo Wellcome Inc. attach to every Lotronex bottle a plain-English pamphlet explaining those risks to patients. Then, the FDA cited 33 reports of severe side effects.

Now, the FDA has received a total of 49 reports of ischemic colitis among Lotronex users, including three women who died, said Dr. Victor Raczkowski, FDA's deputy chief of gastrointestinal drugs. It also has received 21 reports of severe constipation, including 2 deaths.

The FDA hasn't finished investigating the reports to see if Lotronex is to blame, Raczkowski cautioned.

``We're still re-evaluating the risks and benefit of this drug. We are very concerned about these serious adverse events,'' he added.

But Glaxo medical officer Dr. Eric Carter said at least two women weren't still taking Lotronex at the time they died, and a third had suffered ischemic intestinal disease in the past. That means ``she should not have received Lotronex,'' Carter said, stressing how important it is for doctors not to give Lotronex to the wrong patient.

Carter said overall Lotronex is a safe and effective drug, noting that side effects have been reported in only a small fraction of the 300,000 people who have taken the drug.

But Dr. Sidney Wolfe of the consumer advocacy group Public Citizen again petitioned the FDA Monday to ban Lotronex.

``Why continue to endanger the health and lives of tens of thousands of people ... until a 'sufficient' number of hospitalizations and further deaths occur for you to finally take action?'' he wrote FDA Commissioner Jane Henney.

Glaxo currently is negotiating with the FDA over whether it can launch a major consumer advertising campaign, including TV ads, for Lotronex. A key issue is how the company would explain the side effects.

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On the Net:

To see the Lotronex consumer warning brochure: http://www.lotronex.com.





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