FDA Panel Recommends Irritable Bowel Treatment Lotronex Be Sold Again Under ‘Strict Guidelines’
Two FDA advisory committees yesterday recommended that GlaxoSmithKline's irritable bowel treatment Lotronex -- which was removed from the market in November 2000 amid safety concerns -- be allowed to be sold again under strict guidelines, the Washington Post reports. The FDA concluded in 2000 that Lotronex's side effects, which include severe constipation and ischemic colitis, an intestinal inflammation, likely led to 163 hospitalizations and seven deaths for people who took the drug. Glaxo stopped selling the treatment after nine months on the market (Kaufman, Washington Post, 4/24). Yesterday, the FDA's Subcommittee on Drug Safety and Risk Management and its Gastrointestinal Drugs Advisory Committee jointly voted 16-2 to reintroduce Lotronex but with "significant restrictions." The panel recommended Lotronex only for women with "severe chronic diarrhea" that results from a "definitively diagnosed case" of irritable bowel syndrome and said that patients should take only one milligram of the drug per day -- half the originally suggested dose. The FDA usually follows the committees' recommendations, the New York Times reports. The panel said it will have to work further with the company to determine more safeguards, such as how to properly train and certify doctors who prescribe Lotronex (Grady, New York Times, 4/24). The panel also recommended creating a nationwide registry of Lotronex patients, prescribers and pharmacists (Rubin, USA Today, 4/24). If approved, Lotronex would not reach the market for at least six months.
If the FDA follows the panel's recommendation, Lotronex would become the first drug to return to the market after being banned, the New York Times reports. The panel's decision was made after lobbying from a "large group" of Lotronex users who said the medication was the only drug that had allowed them to "resume normal lives" (New York Times, 4/24). Dr. Sidney Wolfe of the consumer advocacy group Public Citizen said at the hearing that Lotronex should not re-enter the general market until "specific scientific studies" have been conducted (Washington Post, 4/24).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.