Novartis has agreed to voluntarily suspend marketing of the drug in the United States, on the FDA's request. After being approved for treatment of chronic constipation for men and women under age 65, Zelnorm is currently still being marketed in 55 countries.
According to the FDA, patients using Zelnorm, also called tegaserod maleate, are advised to contact their health care providers to switch over to alternatives and also added that if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke, they should treat it as emergency.
Earlier this year, Novartis gave the FDA the results of 29 clinical studies of Zelnorm for treatment of a variety of stomach disorders. The results indicated that 13 of 11,614 patients given Zelnorm suffered fatal cardiovascular side effects.
Dr. John K. Jenkins, director of the FDA's Office of New Drugs says that the cardiovascular side effects as "a very rare event" and the "benefits of this drug no longer outweighed the risks for patients."
According to Dr. Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs for Novartis, Zelnorm has health benefits adding, "Although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients."
