• Defective Drug Side Effects

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Novartis AG will no longer sell their constipation drug after a study found that it was linked to an increased chance of stroke, heart attack and an increase in chest pain that could become a heart attack, said federal officials.

The Swiss drug maker agreed to withdraw its drug Zelnorm under pressure from the Food and Drug Administration.

Zelnorm, also known as tegaserod maleate, is a prescription drug used in the short-term treatment of irritable bowel syndrome with constipation in women, and also for the treatment of chronic constipation in patients under 65.

The Risk

Novartis disclosed to the FDA the results of its 29 clinical studies testing its safety and efficacy in the treatment of several gastrointestinal tract conditions. In the testing, 13 of 11,614 patients who were given Zelnorm experienced life-threatening cardiovascular side effects, while only one patient out of the 7,031 who were given a placebo did.

The FDA said that the cardiovascular side effects were rare, but still, it “concluded the benefits of this drug no longer outweighed the risks for patients,” said director of the FDA's Office of New Drugs, Dr. John K. Jenkins.

The Recommendation

The FDA has recommended that doctors who prescribe Zelnorm transition their patients to other drugs or therapies.

The FDA said, “If a population of patients can be identified in whom the benefits of the drug outweigh the risks,” it would consider allowing a small amount of Zelnorm to be reintroduced.

Criticism of the Drug's Initial Approval

Public Citizen, the consumer advocacy group, said it had warned the FDA not to approve the drug back in 2001. But it was approved and in 2005 alone, it was prescribed 2.13 million times.

Dr. Sidney Wolfe, director of the health research group for Public Citizen said, “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.”

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