Zelnorm Recalled Internationally

Seattle, WAZelnorm, a drug manufactured to treat irritable bowel syndrome, is now being recalled internationally. China is the latest country to issue a recall, announcing last month that it had ordered domestic companies to stop making and selling Zelnorm and warning patients not to take the drug. In the U.S., patients who have taken Zelnorm and suffered adverse reactions are now investigating the possibility of filing lawsuits against Novartis.

According to an article at FDA News, China's State Food and Drug Administration said, "The risks of Zelnorm outweigh the possible benefits for some patients based on analyses from home and abroad." China's National Center for Adverse Drug Reaction Monitoring received 98 reports of adverse reactions to Zelnorm. Those reactions included diarrhea, nausea, fast heartbeat, and low blood pressure.

In May, Swissmedic, a Swiss medical agency, ordered a recall for Zelnorm (also known in some countries as Zelmac). Swissmedic said that the risks associated with Zelnorm were greater than the benefits after a study revealed an increased risk of cardiovascular problems.

Meanwhile the European Medicines Agency (EMEA) has never approved Zelnorm for use in Europe. Despite applying for approval twice, Novartis has yet to receive approval from the EMEA. The EMEA said that Zelnorm "would not translate into real benefit to the patient treated," and that the benefits were not greater than its risks.

Earlier this year the U.S. Food and Drug Administration (FDA) asked Novartis, the maker of Zelnorm, to suspend sales of the drug. The request came after an analysis showed a possible link between Zelnorm and an increased risk of cardiovascular adverse events (heart problems). In making the announcement, Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research said, "Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary."

An analysis of 29 short-term Zelnorm trials found that 0.1% of patients who took Zelnorm had cardiovascular ischemic events whereas only 0.01% of patients taking a placebo had a cardiovascular ischemic event. One of the patients taking Zelnorm died while four had heart attacks and three had strokes. Of the patients taking a placebo only one patient had symptoms that suggested the beginning of a stroke; however, those symptoms went away without any complications.

The FDA approved Zelnorm in 2002 for the treatment of irritable bowel syndrome. Zelnorm worked by stimulating the release of chemicals in the intestines that increased the movement of stools through the bowel. Side effects of Zelnorm, other than cardiac events, include severe allergic reactions, abdominal pain, blood in stools, diarrhea, back pain, nausea, and headache. In 2006, sales of Zelnorm, known generically as tegaserod, in the U.S. reached $488 million. A spokesperson for Novartis said the company believes Zelnorm is still useful for the treatment of irritable bowel syndrome.

If you are still taking Zelnorm and experience severe chest pain, shortness of breath, sudden weakness, dizziness, or symptoms of a heart attack or stroke, seek emergency medical attention immediately. The FDA is advising all patients currently taking Zelnorm to contact their doctor to discuss other treatment options.