New FDA Panel on Drug Safety to Consider Potential Reintroduction of Lotronex
A new FDA panel created to tackle the issue of post-market oversight of prescription drugs will meet for the first time next week to discuss the potential reintroduction of Lotronex, a treatment for irritable bowel syndrome that was withdrawn from the market in November 2000 amid safety concerns, the Washington Post reports. The drug was connected to at least five deaths and 49 cases of ischemic colitis -- the blocking of blood flow to the colon -- leading its maker Glaxo Wellcome (now GlaxoSmithKline) to pull the drug from the market. But people with irritable bowel syndrome are asking the FDA and Glaxo to resume sales of the drug. They say that unlike other available treatments, Lotronex helps to control multiple symptoms of the ailment, according to Ray Clouse, a professor of medicine at Washington University in St. Louis and a former official at the American Gastroenterological Association. Lotronex proponents are advocating for the drug to return to the market with almost no restrictions. They want to allow all doctors, not just gastroenterologists, to write prescriptions for a 90-day supply and they also do not want to have to waive their legal rights in the event of serious side effects. However, the consumer-interest group Public Citizen says that Lotronex -- if it is returned to the market at all -- should be restricted to previous users and that patients should be required to sign a consent form acknowledging that ischemic colitis occurs in up to one in 300 users of the drug. In addition, Public Citizen is asking Glaxo to provide a list of all Lotronex users and their physicians to the FDA for periodic monitoring, assessment and data collection. Neither the FDA nor Glaxo have announced their recommendations for a return of Lotronex.
On April 23, FDA officials, consumers, doctors and advocates will gather at a meeting that will be "unusual" both because "very few drugs" that have been pulled off the market over safety concerns have been allowed to return to market and because the meeting will mark the launch of the FDA's new Subcommittee on Drug Safety and Risk Management. The new panel will join the long-standing Gastrointestinal Drug Advisory Committee in considering the reintroduction of Lotronex. The debate surrounding the drug is viewed as a "test case" for how the agency will regulate approved drugs that help "some or even most" patients but subsequently show signs of causing serious side effects or death, the Post reports. According to a report by the General Accounting Office, 51% of drugs approved by the FDA produce serious side effects that are not detected until after they reach the market despite clinical trials. The appearance of such side effects raises the question of whether the government is "justified" in letting patients knowingly risk their lives by taking a medication. That question becomes more difficult for conditions such as irregular bowel syndrome, which is not life-threatening but can reduce a person's quality of life. These issues "show why the new safety subcommittee is desperately needed," drug experts say. The Post reports that the subcommittee, which the FDA says will gain full committee status shortly, is scheduled to meet twice more this year. In addition to regulating drug safety, the subcommittee may recommend ways to better communicate side-effect information to patients. And although the FDA has not announced the agenda for future subcommittee meetings, Public Citizen has already called for a review of two other drugs that have serious side effects in some patients -- the weight loss drug Meridia and the arthritis treatment Arava (Kritz, Washington Post, 4/16).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.