The Chinese Food and Drug administration has put a halt to the production and marketing of Novratis AG’s Zelnorm Drug, for irritable bowel syndrome, as the risk associated with it outweighs the benefits. The patients are asked to stop taking the medication.
The Chinese Drug watchdog posted a statement on its website warning “risks of Zelnorm outweigh the possible benefits for some patients based on analyses from home and abroad." It is believed that the drug is linked to an increased risk of heart attacks and strokes.The National Center for Adverse Drug Reaction Monitoring has received 98 reports of adverse reactions concerning Zelnorm since 2003 when the medicine was introduced to the Chinese market. The adverse reaction involved instances of Diarrhea and Nausea. One reported case was of abnormally fast heartbeat and another case of low blood pressure.
The Novrotis Drug was manufactured by three companies in China and is available in more than 20 provinces with thousands of users.
A review of data from 18,000 patients taking the medicine conducted by Novartis AG, Switzerland's largest drug maker, showed that a significant number had experienced cardiovascular problems. The company had complied with request from The American food and drug administration to with the Zelnorm drug from the market as it was linked with increased risk of heart attack, stroke and chest pain that can become a heart attack, the AP reported.
"We have announced this morning that we are complying with a request from the local authority to suspend the marketing and sales activity of (Zelnorm) in China," Novartis spokeswoman Corinne Hoff said. "More than 85 percent of our sales were in the U.S," she said. "I cannot give you the sales figures for China, but it's not significant," Hoff said.
Source-Medindia
BIN/C
