Novartis AG, the Swiss pharmaceutical giant, has agreed to stop selling Zelnorm, a constipation drug, following complaints that it is linked to higher chances of heart attack and stroke.
Officials of the Food and Drug Administration (FDA) of the US had advised the firm to pull the drug out of the market.
(It is this Novartis that has challenged the rejection of its patent application for a cancer drug by Indian authorities. The suit has been filed in Madras High Court in southern India and the verdict is eagerly awaited as this is the first test case for India's patent laws under the WTO regime.)
Earlier the FDA had approved Zelnorm, also called tegaserod maleate, for short-term treatment of women with irritable bowel syndrome with constipation.
It could also be used by those suffering from constipation but below 65 years of age.
It had been available in the market since 2002 and the FDA approval was granted in September 2004. Interestingly right at the time it was granting approval, the FDA had warned of diarrhea risks associated with the drug.
It said then that it had received several complaints of ischemic colitis, a condition resulting from reduced blood flow to the intestines, which in some cases can cause serious intestinal damage, and rarely death.
It had gone on to add, 'FDA is not thinking of taking Zelnorm off the market at this time. We are adding new information about potential risks of treatment with Zelnorm to the labeling so that doctors and patients can make informed individual treatment decisions.'
But now it says that it has concluded that the overall risk versus benefit profile for the drug is unfavorable for continued marketing.
Its request to Novartis was based on 'newly available information of an increased risk of serious cardiovascular adverse events, including myocardial infarction (heart attack), unstable angina (chest pain), and stroke, associated with use of the drug.'
Doctors who prescribe Zelnorm should work with their patients and switch over to more appropriate treatment, the FDA has said.