GSK Lotronex: 20% Of Scripts Come From Physicians Outside Of Risk Management Plan
This article was originally published in The Pink Sheet Daily
Executive Summary
A survey completed by 36% of all Lotronex patients found they were very aware of the risks of the IBS therapy. FDA says it is too early to evaluate the overall effectiveness of the risk management program.
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One in five scripts for GlaxoSmithKline's Lotronex is written by doctors not enrolled in a physician prescribing program, FDA said. "From month to month approximately 20% of all prescribers of Lotronex are not enrolled in the PPL [Prescribing Program for Lotronex] (most are primary care physicians and family practitioners)," FDA said. FDA's Drug Safety & Risk Management Advisory Committee will receive a progress report on the risk management program for Lotronex (alosetron) on May 5. [Editor's Note: To 1 watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.] "Since marketing began on Nov. 20, 2002, through December 2003, a total of 5,053 physicians have enrolled in the Prescribing Program for Lotronex," FDA's 2 briefing materials note. "About 20% of the enrolled physicians actually prescribed the drug in a given month," FDA said. Lotronex-prescribing physicians who are not enrolled in the program receive enrollment kits and informational letters to encourage their participation. "Over time these interventions have resulted in approximately 75% of the non-enrolled prescribers either enrolling or ceasing to prescribe," the materials state. "Thus, the '20% group' constantly changes in membership as previous non-enrolled prescribers either enroll or cease to prescribe and 'new' non-enrolled prescribers become a part of the group." "Whether patients managed by non-enrolled physicians are at a different risk for clinically serious outcomes is unknown," FDA said. The diarrhea-predominant irritable bowel syndrome therapy Lotronex was withdrawn in 2000 after nine months on the market following 49 reports of ischemic colitis and 21 reports of severe constipation, including three fatalities. GSK re-launched Lotronex in November 2002 under a restricted marketing and distribution program. At the end of 2003, 36% of patients had completed a questionnaire about the risks of Lotronex; most scored 90% or higher. "The generalizability of the results in this survey population to the larger group of all patients treated with Lotronex is unknown," FDA said. FDA received eight reported cases of ischemic colitis and five reported cases of severe complications of constipation as of Feb. 21. Since Lotronex' reintroduction, there have been no deaths associated with the product, the agency said. FDA noted that the low number of adverse events "could be due to low drug use (possibly due to better patient screening initially), better patient awareness of symptoms and/or patient monitoring (possibly due to better education), and a lower starting dose." "However, the [risk management program] is in the early stages of implementation, and compliance and impact of each of the RMP components on overall effectiveness have not been evaluated," FDA said. Novartis has revised the labeling for its IBS therapy Zelnorm (tegaserod) to include the risk of developing severe diarrhea and ischemic colitis (3 (Also see "Novartis Zelnorm Revised Labeling Includes Diarrhea Warning, Ischemic Colitis Precaution" - Pink Sheet, 28 Apr, 2004.)). - Tericke Blanchard |