After receiving thousands of letters from desperate patients, the FDA will convene a panel of outside experts to discuss whether Lotronex, an irritable bowel syndrome(IBS) medication, can come back on the market. To meet demand, FDA official Victor Raczkowski says, his agency has expanded time allowed for public testimony at the advisory committee meeting.
IBS, affecting up to 15% of Americans, causes symptoms including lower abdominal pain, a sudden need to have a bowel movement, diarrhoea and constipation. Lotronex was the first new IBS treatment in years and the only one approved for women who mainly have diarrhoea, roughly one-sixth of all IBS patients. Glaxo Wellcome, now GlaxoSmithKline, pulled Lotronex in December 2000, 8 1/2 months after the drug's debut. About 300,000 patients had taken it, according to Glaxo.
AdvertisementIn June 2000, the FDA began receiving reports of Lotronex users suffering severe constipation and ischemic colitis, or inflammation of the large bowel, caused by reduced blood flow. By year's end, the FDA had learned of 141 such cases, including 7 deaths, according to the Public Citizen Health Research Group, which had petitioned the agency in September 2000 to withdraw the drug. Glaxo and FDA officials have been meeting regularly since January 2001 to discuss ways of limiting adverse effects.