GlaxoSmithKline’s Lotronex risk potential could be characterized by a survey of irritable bowel syndrome patients who are willing to take the drug, the Lotronex Action Group said in comments prepared for FDA’s Risk Management Subcommittee's April 23 meeting.
According to a survey of 485 Lotronex patients conducted by the consumer group, "63% are willing to agree to participate in a survey about use and side-effects, while taking Lotronex, sponsored by the pharmaceutical [company] and/or FDA."
The Lotronex Action Group plans to present its electronic survey results to the Risk Management Subcommittee of the Pharmaceutical Sciences Advisory Committee during the subcommittee’s review of risk management for GSK’s withdrawn IBS therapy Lotronex (alosetron).
Lotronex was withdrawn in 2000 after FDA and the company could not agree on an appropriate risk management strategy to avoid severe GI complications.
The LAG survey showed that 96% of respondents would be willing to sign an informed consent form in order to gain access to Lotronex.
"Our surveys show that IBS sufferers are prepared to accept the risks related to the use of Lotronex and other effective treatments of IBS," the organization said.
The Lotronex Action Group previously suggested an open-label safety study of patients with diarrhea predominant IBS as a short-term risk management plan to GSK.
An outline for the study could include: limiting prescribing to diarrhea predominant IBS patients; requiring a discussion of dosage and risks between patients and physicians; and a monthly or bimonthly doctor visit at the time of prescription refill.
"A waiver could be included preventing legal action against GSK, by the patient, in the event of an adverse side effect," the consumer group proposed in a June 11, 2001 letter.
Potential parameters of a limited-access program are likely to be discussed by the subcommittee. FDA is considering making the drug available to former Lotronex users with severe disease who did not experience adverse events.
GSK has opposed a limited-access program for Lotronex following reports of ischemic colitis and severe constipation. The company chose to withdraw the drug in November 2000, maintaining that a severe limited-access program as proposed by FDA was so restrictive as to be equivalent to withdrawal.