Lotronex Side Effects Law Suit
Lotronex Drug Recall Litigation

The U.S. Food and Drug Administration approved Lotronex (alosetron hydrochloride) in February 2000 to treat the common malady of irritable bowel syndrome (IBS) in women. By November of the same year, its manufacturer, GlaxoSmithKline, removed the drug from the market. The reason: Lotronex resulted in painful illnesses and even death in certain instances.

One side effect of Lotronex was ischemic colitis, a reduced blood flow to the large intestine that can result in abdominal pain, blood in the feces, fever or lower back pain. Of 84 cases reported to the FDA (as of March 2002), 54 patients required hospitalization, 11 had surgery and two died.

The other side effect was severe constipation, so severe that in 113 reported cases, most patients required hospitalization, while 34 had surgery and two died. (Later reports have put the total death toll from both colitis and constipation at six.)

In June 2002, the FDA allowed Lotronex back on the market under restricted conditions. (read the article) It is to be used now only by women with severe diarrhea-predominant (not constipation-predominant) IBS who have not responded to other therapies. The risk of taking Lotronex is considered acceptable in these patients, who suffer serious abdominal pain, fecal incontinence or curtailment of daily activities because of IBS. Still, even these patients must sign a patient-physician agreement before receiving their initial Lotronex prescription.

The cause of irritable bowel syndrome is unknown. The disease is widespread, affecting an estimated 18.5 million Americans, two-thirds of them women, who suffer abdominal pain and discomfort, chronic diarrhea, constipation or both. Lotronex's manufacturer, GlaxoSmithKline, is a London-based firm with headquarters in Philadelphia and Research Triangle Park, N.C.

Kline & Specter, P.C. is a national pharmaceutical litigation law firm. We have represent victims of Lotronex side effects throughout the United States. Click here to find out about more about Kline & Specter including our Doctor/Lawyer Team and our Notable Cases.

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If you or a loved one has suffered a severe side effect after using Lotronex, you need a law firm with the resources and the experience to bring you justice. Please call or e-mail the Lotronex side effects attorneys at Kline & Specter. We'll evaluate your claim for free and we don't get paid unless you do. Our expertise will help you get the compensation you deserve.

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This page was last updated on January 31, 2007.