Zelnorm was first placed on the market to treat women for irritable bowel syndrome (IBS). Ultimately, this drug was taken off the market and lawsuit quickly followed. (October 2018 Update: Believe it or not, Zelnorm might be coming back.)
Zelnorm was approved for “the short-term treatment of women with irritable bowel syndrome (IBS) whose primary bowel symptom is constipation” on July 24, 2002. With regard to the cardiovascular system, the original label listed the following adverse events in the ADVERSE REACTIONS section: “hypotension, angina pectoris, syncope, arrhythmia, bundle branch block, supraventricular tachycardia."
In August 2004, Zelnorm 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 Zelnorm 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 removal of Zelnorm 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 cardiac 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 complicated. Mancomplicatedere 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 drugs didn't.
Lawsuits against Novartis claimed that the drug company should have communicated to doctors, healthcare providers and consumers the true cardiovascular (“CV”) risks associated with Zelnorm when Novartis knew or should have known of the risks. The lawsuits contended that Novartis knew, or should have known as early as the end of 2002, that taking Zelnorm came with an excess risk of cardiac injury but it failed it its duty to timely and adequately warn physicians and healthcare providers of this risk.
There are various arguments about what the warning should have been. But, clearly, Novartis' marketing program neglected to include any reference to ischemic cardiovascular risk with Zelnorm and also may have overemphasized the claims of the efficacy of Zelnorm. This is an important factor in considering the risk.
When a company does not give fair warning, the patient does not have an honest choice. The plaintiffs in this litigation claimed that Novartis' actions unreasonably influenced the prescribing habits of physicians and healthcare providers and deprived them of the right to make educated, informed decisions about the risks and benefits of prescribing Zelnorm to their patients.
In 2017, we see a problem with another IBS drug: Viberzi. The issue here is not a cardiac injury but pancreatitis.