# Glaxo Unsure of Which Patients Suitable for Lotronex



## Brandi Guidry (Jul 9, 2000)

Glaxo Unsure of Which Patients Suitable forLotronex LONDON (Reuters Health) Nov 3 - Many patients with irritable bowelsyndrome (IBS) alternate between the two main forms of the disease, GlaxoWellcome said on Thursday as the US Food and Drug Administration (FDA)continued to investigate 70 reports of adverse events and five deaths in womentaking the company's IBS drug Lotronex. As of October 20, the FDA had received 49 reports of ischemic colitis, acondition in which blood flow to the colon is reduced, and 21 reports of severeconstipation in women taking Lotronex (alosetron) for IBS. Five of these 70women died, FDA spokesman Jason Brodsky said. A Glaxo spokesman denied a causal link had been established between theadverse events and the drug, which has been taken by some 300,000 women inthe US since its launch in March, but which has not yet been approved in Europe. The spokesman told Reuters Health that some women had been misdiagnosedand prescribed Lotronex when they had the constipation-predominant form ofIBS rather than diarrhea-predominant form for which the drug is indicated. According to the spokesman, a correct diagnosis is not straightforward becausemany patients ï¿½ possibly as many as a third of all IBS patients ï¿½ alternatebetween the two types. Although IBS affects men and women, the syndrome is more prevalent in women.Researchers are unsure why this is the case. Glaxo has recently produced a medication guide explaining in lay terms whichpatients should take the drug, and that women should stop using it if symptoms donot improve within four weeks. In August, toughened warnings on the drug's label advised consumers to watch forsigns of side effects, including ischemic colitis. It has also urged women to talkwith their doctors, and to consult the medication guide. The US public advocacy group Public Citizen has petitioned the FDA to removeLotronex from the market because of the risk to women's health. The groupadded that the product has been shown in trials to be only marginally moreeffective than placebo at treating the disorder.


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## JeanG (Oct 20, 1999)

Thanks for posting this, Brandi. I wonder what the latest is on this? It's helped so many people.JeanG


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## Mike NoLomotil (Jun 6, 2000)

Nothing substantive new since Nov. 3.


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