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Constipation drug pulled at FDA's request

March 30th, 2007 11:36 pm by Associated Press




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


Novartis agreed to withdraw Zelnorm at the FDA's request, the agency said in a public health advisory.


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


Doctors who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate, the FDA added.


Earlier this year, Novartis gave the FDA the results of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.


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 Dr. John K. Jenkins, director of the FDA's Office of New Drugs.


The FDA has told Novartis it would consider allowing a limited reintroduction of Zelnorm "if a population of patients can be identified in whom the benefits of the drug outweigh the risks," the agency said.


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 Dr. Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs for Novartis.


The FDA first approved Zelnorm in 2002. The agency did not have data concerning how often it's prescribed in the U.S.


However, Public Citizen, a consumer advocacy group, said that there were 2.13 million prescriptions issued for Zelnorm in 2005 alone, making it one of the top 200 drugs in the country. The organization also said that it had warned the FDA in 2001 not to approve the drug for safety reasons.


"Once again, the FDA has approved a drug with marginal effectiveness in the face of serious questions about its safety - putting at risk the millions of people who have already used it," said Dr. Sidney Wolfe, director of Public Citizen's health research group. Jenkins said that Novartis first informed the FDA on Feb. 22 about the data it had accumulated. The agency asked for more information for a review. On Wednesday, FDA asked the company to discontinue marketing the drug. The company agreed to do so on Thursday. AP-CS-03-30-07 1751EDT

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