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Background
Lotronex® is the brand name for the drug Alosetron, manufactured by Glaxo Wellcome, Inc. Lotronex was prescribed for irritable bowel syndrome (IBS). IBS, also knows as “spastic colon,” is a disorder that affects up to 15 percent of Americans, mostly women. In IBS, the bowel is hypersensitive. 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® received approval from the Food and Drug Administration for the treatment of women with
diarrhea-predominant IBS in the U.S. on February 9, 2000. According to press reports, by November 2000, the FDA received 93 reports of patients being hospitalized after taking Lotronex®,
and 49 reports of patients developing ischemic colitis, a potentially lethal complication stemming from inadequate blood flow to the colon. At least three deaths have also been reported.
On October 30, 2000, Dr. Sidney M. Wolfe of the Public Citizen health Research Group wrote to the Food & Drug Administration
requesting that Lotronex® be removed from the market. Dr. Wolfe noted that Lotronex® was associated with ischemic colitis even in young persons where this disease is extremely rare.
The Withdrawal of Lotronex
On November 28, 2000, the FDA announced that it had asked Glaxo Wellcome to withdraw Lotronex® from the market. The FDA is advising patients taking Lotronex® to contact their health care providers to discuss treatment alternatives for Irritable Bowel Syndrome.
The Lotronex® Controversy
The FDA approved Lotronex® after just a seven-month review process as part of a “fast track” approval process. With the recent withdrawal of Lotronex®,
this marks the 10th time from 1998 to 2000 that the FDA has requested the withdrawal of a prescription drug from the market for safety reasons.
As investigation by the Los Angeles Times, published on November 2, 2000, found that multiple persons had developed ischemic
colitis, a potentially life-threatening complication, after using Lotronex®. The Los Angeles Times concluded that the FDA: disregarded the significance of concerns raised by an agency
medical officer who examined Lotronex® before its approval;chose a paid consultant of Glaxo Wellcome to serve with an advisory committee that recommended approval of the drug; rather than wait for Glaxo Wellcome to conduct a major new study of the drug’s alleged link to ischemic colitis, the FDA approved Lotronex® on the condition that the study would take place after the drug entered the market. The study did not commence prior to the withdrawal of Lotronex®.
On December 11, 2000, U.S. News and World Report released the results of its investigation of the approval of Lotronex®.
Relying on hundreds of pages of FDA and Glaxo Wellcome documents, he magazine concluded that Glaxo Wellcome “sought to market the drug broadly and downplayed the likelihood that Lotronex® could cause dangerous constipation.” The magazine also alleged that an FDA medical reviewer had written that Glaxo Wellcome had, in a proposed warning label for the drug, “buried in the fine print” the disclosure of the more serious side effect of ischemic colitis.
If you or a family member have suffered ischemic colitis or other serious complications after taking Lotronex®,
please fill out a case information form.
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