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This article was featured in USA Today:Irritable bowel medication to carry special warning Some women who took drug had side effects By Rita RubinUSA TODAY Bottles of Lotronex, prescribed for women with irritable bowel syndrome, will now bear special leaflets warning of ''rare but serious risks'' associated with the drug, the Food and Drug Administration says. Labeling for health professionals also will be revised to reflect the risks, says FDA spokesman Jason Brodsky. Lotronex won FDA approval in February and became widely available in early March. It is the first drug marketed to treat women with irritable bowel syndrome whose main symptom is diarrhea. As of last week, Lotronex had racked up 320,000 prescriptions, according to maker Glaxo Wellcome of Research Triangle Park, N.C. Through June 1, the agency had received seven reports of serious complications of constipation in women who had taken Lotronex. Six of those patients were hospitalized, and three of them required surgery, according to FDA officials. During the same period, the agency also received eight reports of ischemic colitis, or inflammation of the large bowel caused by reduced blood flow, in patients taking Lotronex. Four of the women needed to be hospitalized, but none required surgery. At a meeting June 27, the advisory committee that recommended approving Lotronex urged that patients be given information explaining the risks. Brodsky says the agency has received additional reports of similar complications since June 1 and is investigating them. Still, he says, ''the agency believes this is a safe and effective product when used as labeled.'' While 25% to 30% of those who took Lotronex in clinical trials leading up to its approval experienced constipation, none of the patients were reported to have serious complications, according to the FDA. Four cases of ischemic colitis were reported in patients who were involved in the trials. Lotronex becomes the first drug to carry a ''medication guide,'' a FDA-approved patient labeling developed under regulations that went into effect in 1999. Glaxo Wellcome also is mailing out ''Dear Health Care Professional'' letters to alert those who prescribe the drug to the revised professional labeling. ''Dear Pharmacist'' letters from the company will inform pharmacists that they must provide a medication guide with each Lotronex prescription that they fill. ------------------~Kel
 
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