On Friday, Novartis stopped sales and promotions of its anti-constipation drug Zelnorm in both the US and Canada. Zelnorm has been linked to stroke, a higher risk of heart attack and chest pain. The FDA concluded that for patients, the benefits no longer outweighed the risks. It also suggests that if patients taking Zelnorm experience any of the following they should seek emergency care:
— severe chest pain
— shortness of breath
— dizziness
— sudden onset of weakness
— difficulty walking or talking
— any other symptoms of stroke or a heart attack.
Zelnorm was originally approved in 2002 for short-term treatment against irritable bowel syndrome (IBS). In 2004 it was also approved for treatment against chronic constipation for people under 65. Canada approved use of the drug last year for the same conditions.
Recent studies reported by Novartis to the FDA indicated that the risk of serious heart problems is considerably higher with patients taking Zelnorm, than those taking a placebo. Of the 11,600 patients taking Zelnorm 13 confirmed heart problems, while only one of over 7,000 placebo patients reported similar problems.
If you or any one you know is taking Zelnorm you should stop immediately. To receive a refund on any unused, non-expired pills in the US you can return them to Novartis. Contact the Novartis Customer Interaction Center at 888-669-6682 for details on where to return pills.
In Canada you can return unused, non-expired pills to your pharmacy for a refund. Be sure to pass this important health alert on to friends and family — your health is your most valuable asset, don’t risk it.