Lotronex, originally approved for the treatment of irritable bowel syndrome (IBS) was removed after only eight months and has now resurfaced.

            It is now available to a restricted number of people- only for patients who have the severe, diarrhea-predominant form of IBS-and there is still no guarantee that Lotronex is safe.

            “It is still the case that we don’t know what the risk factors are to predict which patients will get severe complications and which won’t,” according to Victor Raczkowski, M.D. and Deputy Chief of Gastrointestinal Drugs at the FDA.

            Lotronex was linked to four deaths and nearly 200 serious cases of blocked blood flow or severe constipation; many cases resulted in surgery and some of those people are now permanently disabled.

            Current data suggests that one in every 350 women who take Lotronex, for a six-month period, will suffer blocked blood flow to the intestine- a sometimes fatal condition.  The risk for women who take the drug for more than six months is unknown.

            The FDA has granted re-approval, but with unprecedented restrictions.  Lotronex will only be available to women with IBS and diarrhea, so severe it disrupts daily life; patients must sign an agreement that their doctor explained the risks, they understand the risks, and must promise to follow a four-page guide to taking Lotronex; doctors must sign a contract stating that they are qualified to treat IBS, that they told their patients of the risks and they will report any and all adverse reactions to the FDA and GlaxoSmithKline, the manufacturer of the drug.

SOURCE: WebMD Health, www.my.webmd.com, June 7, 2002.