Zelnorm Recall
June 8, 2007China 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.According to the agency, China’s National Center for Drug Reaction Monitoring has received at least 98 reports of patients who have experienced Zelnorm side effects since the drug went on sale there. In addition to abdominal and stomach problems, Zelnorm has also been linked to an increased risk of heart attack, stroke and other cardiovascular side effects.
A spokesman for the Chinese health agency said that the possible risk of Zelnorm side effects made it too dangerous to remain on the market. “The risks of Zelnorm outweigh the possible benefits for some patients based on analysis from home and abroad,” a posting on the agency’s website says.
Novartis Pharmaceutical, the manufacturer of Zelnorm, agreed to stop selling the drug in the U.S. in March after it was linked to a greater risk of heart attack, stroke and chest pain. Although the FDA says that Novartis is planning to issue a Zelnorm recall, no date for this has been announced.