Novartis said Friday it has pulled its irritable bowel treatment Zelnorm (tegaserod maleate) off the US market after new clinical data showed an increased risk of cardiovascular events in patients taking the drug.
Globally, Zelnorm ranked as Novartis’ 12th best-selling drug in 2006, grossing $561 million. But the drug was far more important to the firm in the US, where it ranked seventh in Novartis’ portfolio with $488 million in sales – up 37% over 2005 figures. According to TNS Media Intelligence, Novartis spent $290 million in measured media promoting the drug to US consumers from its 2003 launch through 2006, including its award-winning “Tummies” ad campaign.
Novartis will continue to hold off on marketing, sales and distribution of Zelnorm until further public discussion and an FDA Advisory Committee meeting can take place to determine the drug’s risks and benefits.
In late February and early March 2007, Novartis gave the FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions.
The data from all the studies were combined to assess the chance of side effects on the heart and blood vessels. In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm. These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill. The average age of patients in these studies was 43 and most patients — 88% were women.
The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small. However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill. Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects. Among these, four patients had a heart attack, one died, six had a type of severe heart chest pain which can quickly turn into a heart attack and three had a stroke. Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.
Zelnorm received FDA approval for the short-term treatment of women with irritable bowel syndrome in the US in July 2002. Zelnorm also received FDA approval for the treatment of men and women less than 65 years of age with chronic idiopathic constipation in the US in August 2004.
Last year, Zelnorm was rejected for a second time by a European Union health advisory panel, which said the medicine’s risks outweighed its benefits.