Public Citizen Urges FDA Not to Approve Tegaserod For IBS – (04-30-01)

Public Citizen Urges FDA Not to Approve Tegaserod For IBS

There have been numerous attempts by the pharmaceuticals to tap into the irritable bowel syndrome market. The first attempt was pulled off the market for safety concerns (Glaxo Wellcome’s Lotronex for diarrhea-dominant IBS). Tegaserod is the latest attempt to help with constipation-dominant IBS. It’s a shame that all this money is spent on R&D when natural physicians have been doing well with IBS for years…

(article) Consumer advocacy group Public Citizen has petitioned the US Food and Drug Administration not to approve Novartis Pharmaceuticals’ drug candidate tegaserod (Zelmac) as a treatment for the constipation-predominant form of irritable bowel syndrome (IBS), citing the drug’s “questionable efficacy” and “serious safety concerns.” In August, the FDA issued the Swiss pharmaceuticals firm an approvable letter for tegaserod, with final approval conditioned on the submission of additional clinical data. FDA reviewers have estimated that tegaserod recipients were three times more likely to develop cysts than placebo recipients, Public Citizen asserts in the letter. It noted that in animal trials the compound “caused a statistically significant, dose-related increase in their incidence.” In addition, the drug has not even been proven effective, Public Citizen maintains. “Only a minority of patients ‘respond’ to the drug and the absolute benefits conferred (compared to placebo) are not clinically significant,” it said.

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