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August 6, 2007 FDA will allow Zelnorm only when benefits outweigh the risks

The Food and Drug Administration has announced that it will allow doctors to prescribe the irritable bowel syndrome drug Zelnorm to a limited number of patients for whom its benefits outweigh the risk of cardiovascular problems. The agency had asked the drug’s manufacturer, Novartis Pharmaceutical, to withdraw it from the market in March due to the potential risk of Zelnorm side effects. Read more...

June 8, 2007 China orders companies to stop selling Zelnorm

China’s State Food and Drug Administration has ordered domestic companies to stop manufacturing and selling the irritable bowel syndrome drug Zelnorm. The agency also warned patients to stop taking the drug because of the risk of Zelnorm side effects. Read more...

April 2, 2007 Zelnorm profits depended on ad blitz, CEO says

According to a recent article in Forbes magazine, sales of the irritable bowel syndrome (IBS) drug Zelnorm increased by more than one-third thanks to a series of television advertisements promoting the drug. Zelnorm was recently withdrawn by its manufacturer, Novartis, after it was linked with an increased risk of heart attack, stroke and other cardiovascular side effects of Zelnorm. Officials from the Food and Drug Administration say that Novartis is planning to issue a Zelnorm recall, although no date has been announced. Read more...

March 30, 2007 Consumer group warned of Zelnorm side effects risk in 2001

A consumer advocacy group says that the Food and Drug Administration should have never approved the irritable bowel syndrome (IBS) drug Zelnorm. Public Citizen says that it warned of the risk of Zelnorm side effects in 2001, including ovarian cysts, fainting and heart problems. Zelnorm was withdrawn by Novartis Pharmaceuticals at the FDA’s request this week because of its increased risk of causing heart attack and stroke. Read more...

March 30, 2007 Zelnorm withdrawn by Novartis

Novartis Pharmaceuticals has withdrawn its popular irritable bowel syndrome drug Zelnorm at the request of the Food and Drug Administration. The agency requested that Novartis stop sales and marketing of Zelnorm after studies revealed that it could lead to an increased risk of cardiovascular problems. Read more...

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