FDA Officials Consider Reintroducing Lotronex

According to government documents obtained by the Los Angeles Times, the FDA intends to bring the irritable bowel syndrome drug Lotronex back to the market, despite evidence that the risk of developing ischemic cholitis, a potentially lethal complication, is higher than previously thought. While on the U.S. market last year for eight months, 514,000 Lotronex prescriptions were filled or refilled, and the drug generated $50 million in sales. However, Lotronex was taken off the market last November, after being was cited as the "primary suspect" in 11 deaths and 72 cases of ischemic colitis. Within weeks of the drug's withdrawal, several Lotronex users "implored" Janet Woodcock, director of the FDA's drug evaluation center, to bring the drug back. In clinical trials, between 10% and 20% of Lotronex users' symptoms improved, but the FDA now estimates that people taking the drug for at least three months would have a one in 218 chance of developing ischemic colitis. When Lotronex first hit the market, the drug's label indicated that ischemic colitis was an "infrequent" complication; the labeling later was changed to say that one in 700 people who took Lotronex were at risk for developing the condition.

Despite the FDA's new estimates of the risk associated with Lotronex, Woodcock privately has "voiced support" for the drug's re-entry into the market. Although Woodcock declined to comment on the situation, FDA spokesperson Jason Brodsky said, "FDA is committed to resolving the issues surrounding Lotronex. From the agency's perspective, progress is being made." The controversy over Lotronex "once again puts a spotlight on the FDA's handling of a drug with demonstrated lethal risk and modest proven benefits," the Times reports. At an FDA advisory committee meeting tentatively scheduled for July 13, the panel will likely be instructed by Woodcock's staff to recommend the best conditions under which to reintroduce the drug. Ramona DuBose, a spokesperson for Lotronex maker GlaxoSmithKline, said, "We are hoping that through our discussions with FDA, that we can come up with a risk-management plan that will allow the medicine to be available to patients who can derive some benefit from it while minimizing any potential risk." The possibility of the drug's market re-entry has sparked concern among consumer advocates. Public Citizen's Dr. Sidney Wolfe, who called for Lotronex' withdrawal last summer, said he opposes the drug's reintroduction, adding that Lotronex "never should have come on the market" (Willman, Los Angeles Times, 5/30).