Constipation Drug Pulled Upon FDA's Request

Associated Press
Saturday, March 31, 2007

The Swiss pharmaceutical maker Novartis AG will stop selling a drug designed to relieve constipation after it was linked to a higher risk of heart attack, stroke and worsening chest pain that can become a heart attack, federal health officials said yesterday.

Novartis agreed to withdraw Zelnorm at the FDA's request, the agency said.

Zelnorm, also called tegaserod maleate, is a prescription medication approved for the short-term treatment of women with irritable bowel syndrome, as well as of men and women younger than 65 with chronic constipation, the FDA said.

Doctors should work with patients who take Zelnorm to help them switch to other therapies, the FDA added.

Earlier this year, Novartis gave the FDA the results of 29 clinical studies of Zelnorm as used in the treatment of a variety of gastrointestinal conditions. The analyses showed that 13 of 11,614 patients given Zelnorm experienced serious and life-threatening cardiovascular side effects, while only one of the 7,031 patients given placebos did.

FDA officials described the cardiovascular side effects as "a very rare event." Still, "we concluded the benefits of this drug no longer outweighed the risks for patients," said John K. Jenkins, director of the FDA's Office of New Drugs.

Novartis said it believes the drug provides unique benefits.

"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," said Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs at Novartis.

The FDA first approved Zelnorm in 2002.

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