Latebreakers: Constipation drug Zelnorm removed from market

April 16, 2007

Patients suffering from irritable bowel syndrome with constipation or chronic constipation will no longer have the option of treatment with tegaserod (Zelnorm).

Patients suffering from irritable bowel syndrome with constipation or chronic constipation will no longer have the option of treatment with tegaserod (Zelnorm). Novartis has moved to suspend marketing, sales, and distribution of the drug at the request of the FDA after a retrospective analysis of more than 18,000 patients in the clinical trial database revealed an increased risk for cardiovascular events, including myocardial infarction, stroke, and unstable angina pectoris. The risk is relatively small (0.11%), according to the manufacturer, but significant. The data showed 13 events in a total of 11,614 patients treated with tegaserod, compared with one case in 7,031 patients treated with placebo (0.01%). All 13 patients affected also had preexisting cardiovascular disease and/or risk factors. The FDA is willing to consider a limited reintroduction of the drug in the future if Novartis can identify a select subpopulation of patients in whom the benefits outweigh the risks.