Zelnorm is dead.
Novartis pulled bowel drug Zelnorm from U.S. shelves on Friday at the request of the FDA, because clinical trial data indicated a link to heart attacks and strokes.
In fact, in a large clinical trial with 18,000 patients, researchers found 13 times as many patients treated with Zelnorm experienced heart attack, stroke, or angina compared to placebo-treated patients.
The actual number of patients affected, however, were small; only 13 patients, so who knows how bad this is.
The drug had been approved in July, 2002 for women who had constipation caused by irritable bowel syndrome. In August, 2004, men and women under age 65 could also use the drug.
This was a drug in search of patients, and Novartis had a hard time proving it was effective for anything. But they did funny television commercials of women with stuff written on their tummies.
In Europe, Novartis was never able to convince the regulators to approve the drug. Mean-spirited individuals might claim that was because European regulatory authorities are not paid off like the FDA. Of course, that is a simplification, which I don't believe is true.
FDA officials said Zelnorm might be able to return on a limited basis but only if a group of patients could be identified for whom the benefits outweighed the risks.
Yeah, that'll be the day.
Zelnorm was Novartis' 12th-biggest selling drug in 2006, with global turnover growing 30 percent to $561 million, of which $488 million was generated in the United States.
About 500,000 U.S. patients are taking Zelnorm, Novartis spokeswoman Anna Frable said.
Lawsuits next, anyone?