Following FDA's Action, Novartis' Zelnorm Gets Recall Order From Chinese Drug Regulator

China's State Food & Drug Administration Says Zelnorm Side Effect Risks Outweigh This Drug's Benefits

(Posted by Tom Lamb at DrugInjuryWatch.com)

A June 8, 2007 Associated Press (AP) article published in The Washington Post reports China's drug regulator has ordered a stop to the production and sales of Novartis AG's Zelnorm in that country.

China's State Food and Drug Administration warned patients to stop taking Zelnorm for irritable bowel syndrome, and said in a statement posted to agency's Web site: "The risks of Zelnorm outweigh the possible benefits for some patients based on analyses from home and abroad."

According to this June 8 AP article about Zelnorm:

The agency said China's National Center for Adverse Drug Reaction Monitoring has received 98 reports of adverse reactions concerning Zelnorm since it was introduced to the Chinese market in 2003. Most involved diarrhea and nausea, with one reported case of abnormally fast heartbeat and another of low blood pressure....

The official Xinhua News Agency said that hundreds of thousands of Chinese patients use the drug.

In March 2007 Novartis agreed to recall Zelnorm in the U.S. at the FDA's request after this constipation drug was linked to a higher chance of heart attack, stroke, and angina (worsening chest pain that can become a heart attack). Later, in June 2007, Novartis was ordered by Swiss regulators to stop selling Zelnorm, which is known as Zelmac in Switzerland.