5:31 p.m.
A popular drug used to treat constipation was pulled from the U.S. market today after federal investigators found the drug is linked to an increased risk of heart attacks and strokes.
The Food and Drug Administration released a public health advisory today notifying the public that Novartis Pharmaceuticals Corp., a Swiss drug maker, had agreed to stop selling Zelnorm. Zelnorm was approved by the FDA in 2002 and accounted for $561 million in U.S. sales last year.
Zelnorm is being taken off the market because a new safety analysis found a higher chance of heart attack, stroke and worsening heart chest pain than previously thought, the FDA said.
Zelnorm is a prescription medication approved for short-term treatment of women with constipation and was approved in 2004 for patients younger than 65 with chronic constipation. About 500,000 people are taking Zelnorm, and an estimated 12 million Americans suffer from symptoms related to the problem.
Novartis’ decision to abide by the FDA’s request to remove Zelnorm from the market resulted from test results Novartis submitted to the FDA earlier this year. The results showed that 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects. All patients treated in the study had pre-existing cardiovascular disease.
FDA officials described the cardiovascular side effects as “a very rare event” but decided to request the removal because the agency concluded the benefits of Zelnorm “no longer outweighed the risks for patients with constipation,” said Dr. John K. Jenkins, director of the FDA’s Office of New Drugs.
Novartis is standing behind Zelnorm’s 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 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. For patients with no treatment options other than Zelnorm, the FDA said it will work with Novartis to allow access to the drug for those patients through a special program.
Zelnorm will no longer be sold in Canada but will remain on the market in Switzerland.
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