Zelnorm was first placed on the market to treat women for irritable bowel syndrome(IBS). In August, 2004, Zelnorn was given the additional indication by the FDA for short term treatment of chronic constipation in men and women under the age of 65. Irritable bowel syndrome is a disorder that interferes the functions of the large intestine. Symptoms of IBS include cramps, abdominal pain, bloating, constipation, and diarrhea.
Novartis sales of Zelnorn in 2006 were $561 million, paying off with ease the $325 million Novartis spend on marking Zelnorm to doctors and patients of the last three years.The Zelnorm Recall
In March, 2007, the FDA recommended that Zelnorm be removed from the market after reviewing the data from 29 different clinical trials involving Zelnorm that found that users of Zelnorm experience heart attacks, strokes and angina at a rate 7 to 8 times greater than those who took a placebo. Accordingly, the FDA determined that the risk of heart attack or other serious cardic injury required Zelnorm's removal from the market. Zelnorm remains on the market today for use in extreme IBS cases.
Taking Zelnorm off the market was the right idea. The drug's risks are unacceptable. But these comments underscore that the decision to take a drug off the market is complicted. Many people were being treated for IBS with Zelnorm were willing to take the risk of death - think about that - because the Zelnorm worked for them when other druges didn't..