FDA Allows Irritable Bowel Syndrome Drug Lotronex to Return to Market with Restrictions
The FDA last Friday agreed to allow Lotronex, an irritable bowel syndrome drug manufactured by GlaxoSmithKline PLC, to return to the market "after it was pulled because of links to hospitalizations and several deaths," the Wall Street Journal reports (Naik/Carroll, Wall Street Journal, 6/10). The decision marks the first time that the FDA has allowed a treatment withdrawn over safety concerns to return to the market (Kaufman, Washington Post, 6/8). In 2000, the FDA concluded that Lotronex, which can cause severe constipation and ischemic colitis, an intestinal inflammation, likely led to 163 hospitalizations and seven deaths in patients who took the drug. After nine months on the market, GSK withdrew the treatment in November 2000 (California Healthline, 4/24). However, thousands of patients protested the withdrawal of Lotronex, which they said "was the only treatment to have aided them," and their "pleas helped persuade" the FDA and GSK to "find a way to reinstate it" (Grady, New York Times, 6/9). According to GlaxoSmithKline, Lotronex will return to the market by the end of the year (Washington Post, 6/8).
The FDA has established new rules for the use of Lotronex. Under the rules, doctors must "self attest" that they can diagnose and treat irritable bowel syndrome and "recognize and treat" side effects of Lotronex before they prescribe the drug. In addition, the rules require doctors to explain the risks and benefits of Lotronex to patients and report adverse events to GSK or the FDA. The rules also mandate that patients who take Lotronex must sign an agreement "acknowledging its risks" and promise to inform their doctors "if they develop any symptoms considered to be dangerous" (New York Times, 6/9). Under the rules, patients must meet with their doctors for refills, and pharmacists may only fill Lotronex prescriptions that have a "special GSK sticker showing an approved doctor wrote the prescription and the patient signed the Lotronex agreement" (Neergaard, AP/Nando Times, 6/8). The rules also restrict use of Lotronex to women with severe cases of irritable bowel syndrome that have not responded to other treatments, the New York Times reports. In addition, the rules reduce the recommended dose of Lotronex to one milligram per day, half of the dose that the FDA recommended in the past (New York Times, 6/9). About 275,000 patients took Lotronex before GSK withdrew the treatment from the market, but the new FDA rules will limit use of the drug to an estimated 100,000 patients (Washington Post, 6/8). GSK also said that the price of a month's supply of Lotronex -- $175 before the withdrawal -- would increase as a result of costs related to the rules.
Dr. Victor Raczkowski, deputy director of the FDA office that evaluates gastrointestinal drugs, said that the agency agreed to allow Lotronex to return to the market to help "desperate patients who had no other effective treatment." He described the move as a "unique case" and "not part of any overall FDA strategy to bring back withdrawn drugs." Public Citizen, a consumer advocacy group that petitioned the FDA to withdraw Lotronex from the market, questioned the agency's decision to allow the treatment to return and "disparaged" the new rules for use of the treatment (New York Times, 6/9). Dr. Larry Sasich of the Public Citizen Health Research Group said that the FDA should only allow gastroenterologists to prescribe Lotronex and that the agency should establish "registries" of pharmacists, patients and doctors to monitor Lotronex patients (Rubin, USA Today, 6/10). Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, added that the FDA should consider Lotronex an experimental treatment and collect data on patients who take the drug (New York Times, 6/9).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.