Novartis Slumps After Pulling Zelnorm

Apr 02, 10:17 AM

Current Headlines: Swiss pharmaceutical giant Novartis (NVS) said Mar. 30 it's suspended its U.S. marketing and sales of Zelnorm, a treatment for constipation caused by irritable bowel syndrome. The Food and Drug Administration suggested the treatment carries with it a risk of heart problems or strokes.

The drug had been approved in July, 2002 for women who had the complication. In August, 2004, men and women under age 65 could also use the drug.

But as part of an ongoing review involving a number of health authorities including the FDA, Novartis analyzed data from more than 18,000 patients. Researchers found that 13 out of 11,614 patients treated with Zelnorm experienced events like heart attack, stroke, or angina. Only one case in 7,031 placebo-treated patients experienced such events. All patients affected had pre-existing cardiovascular disease.

"My review of the data suggested that a causal relationship is unlikely" between heart problems and Zelnorm use, said Jeffrey L. Anderson, MD, an independent cardiologist at the University of Utah who reviewed the data. "Furthermore, the data did not show any consistent pattern of event type, time to event or dose relationship in tegaserod-treated patients."

But the FDA is now advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. "Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke," the FDA said in a press release Mar. 30.

The FDA is still working with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options, or in other cases where the benefits may outweigh the risks. "This decision reflects the FDA's commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits," said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research, in a press release March 30.

Zelnorm is just one of many drugs made by Novartis. For example, the company has a range of hypertension drugs including Diovan, which generated more than $4 billion in 2006 sales [see BusinessWeek.com, 03/07/2007, "Novartis' New Blood Pressure Weapon", http://www.businessweek.com/globalbiz/content/mar2007/gb20070306_897613.htm?chan=search.]

Investors sold Novartis stock nearly 4% to $54.63 per share on the New York Stock Exchange Mar. 30.