Zelnorm Recall
On March 30, 2007, Novartis Pharmaceuticals agreed to a request by the FDA to withdraw its irritable bowel syndrome (IBS) and constipation drug Zelnorm from sale in the U.S.
The FDA made its request after an analysis of mulitple Zelnorm studies by Novartis revealed that patients taking the drug had about eight times the risk of heart attack, stroke or other heart problems, compared with patients given a placebo.
Novartis’ own studies revealed that patients taking Zelnorm were eight times more likely to suffer a heart attack or stroke.
Rising concerns over Zelnorm
Concerns about Zelnorm arose when drug officials asked Novartis to conduct a routine safety review of the drug. The company found 13 cases of heart problems in patients who were given Zelnorm during its studies, compared with only one patient who was given a placebo.
The data showed about eight times as many cases of Zelnorm heart attacks or other cardiovascular problems compared with placebo patients.
Withdrawn from the market
Novartis reported these findings to the FDA in February 2007, and over the next month, safety officials with the agency assessed the risk of Zelnorm side effects faced by patients taking the drug.
Novartis then agreed to stop sales and marketing of Zelnorm in the U.S. The company has also agreed to refund patients for any unused portion of their Zelnorm prescriptions.
According to information released by the FDA, Novartis plans to issue a Zelnorm recall in order to remove the drug from pharmacies in the U.S. No date has been set for the planned Zelnorm recall.
