Glaxo Pulls Lotronex from Market
Following reports of deaths and hospitalizations resulting from the use of Lotronex -- an irritable bowel syndrome drug which had received "fast-track" FDA approval -- Glaxo Wellcome Inc. pulled the drug from the market yesterday after losing a protracted battle with the agency over safety problems, the Los Angeles Times reports. In a Tuesday statement, the FDA said that the agency had received reports of five deaths in patients using Lotronex, as well as 49 cases of ischemic colitis -- a potentially fatal condition resulting from inadequate blood flow to the colon -- and 21 cases of severe constipation. FDA officials and Glaxo executives met Tuesday in Rockville, Md., to discuss safety concerns related to the drug. While Glaxo Chair Robert Ingram argued that the company could manage the potential side effects with revised labeling, agency officials recommended stricter "controls" (Willman, Los Angeles Times 11/29).
According to Victor Raczkowski, deputy director of the FDA's office of drug evaluation, the agency suggested a "physician certification program" that would have limited the drug to patients with the "most severe" symptoms, a plan rejected by Glaxo. Company spokesperson Ramona DuBose called the program "impractical," arguing that the "restrictions on physicians and patients ... were so severe that it was tantamount to withdrawal" (Lueck/Moore, Wall Street Journal, 11/29). Calling the FDA's proposed restrictions "non-doable," Glaxo CMO and vice president Dr. Richard Kent said that the British drug giant had "no choice" but to pull Lotronex from the market (Rubin, USA Today, 11/29). He added, "We said to the FDA, 'Look, these (proposed controls) are no-gos. We believe you're asking us to remove the drug. So, we are going to remove the drug.'" Kent also argued that the dangers posed by Lotronex compare with those in other medications, including pain relievers. In a Tuesday statement, Glaxo acknowledged the "rare reports of fatalities" associated with Lotronex but denied a "causal relationship," despite FDA reports that pinpoint the drug as the "primary suspect" in five deaths.
Glaxo's decision to remove Lotronex from the market represents the 10th time in three years that a prescription drug "has been banished" for safety concerns and raises doubts about the FDA's "fast-track" approval process for non-lifesaving medications, the Times reports. On Feb. 9, the FDA approved Lotronex for treating irritable bowel syndrome in women, following a seven-month review -- five months less than the one-year standard. FDA officials approved Lotronex despite "emphatic warnings" that the drug could cause ischemic colitis and constipation. "Lotronex is only the latest 'fast-track' drug to be withdrawn by the FDA," Rep. Henry Waxman (D-Calif.) said, adding, "There's now a real question of whether the right balance of approval speed and safety is being struck" (Los Angeles Times, 11/29). Raczkowski defended the FDA's decision to sanction Lotronex and the agency's record on drug approvals, noting that the rate of pharmaceutical withdrawal has not increased from 20 years ago. However, according to Sidney Wolfe of the consumer group Public Citizen, "The red flag was up very high and early on [Lotronex], and unfortunately the FDA and the company did not pay attention. ... The FDA was bending over backwards to keep it available, when they should have been pushing hard to get it removed" (Kaufman, Washington Post, 11/29). He added, "Hopefully, the FDA has learned something" (Wall Street Journal, 11/29).
Wolfe also called Lotronex "barely more effective than a sugar pill," noting that the drug has no "unique advantage that really overcomes the deaths and injuries it is causing" (USA Today, 11/29). The
AP/Richmond Times-Dispatch reports that in clinical studies, Lotronex only provided "modest relief" to women, "did not work for" men and "was declared downright dangerous" for those suffering from constipation (AP/Richmond Times-Dispatch, 11/29).
The decision to pull Lotronex from the market also killed Glaxo's "once-bright hopes" that the drug would become a "blockbuster" and buoy the company's pharmaceutical empire, the Philadelphia Inquirer reports. In February, Raymond James analyst Michael Krensavage called Lotronex "a big drug for Glaxo and one that needs to work." Experts called the drug a potential "$1 billion seller" and a "driver of growth" for the company, which lost the patent on its blockbuster ulcer medication Zantac in 1996 (Knox, Philadelphia Inquirer, 11/29). Through September, Lotronex sales totaled $50.4 million, according to IMS Health. Glaxo's stock price fell 4.4% to $56.56 after Tuesday's announcement (Los Angeles Times, 11/29).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.