Class Action Lawsuit Involving Zelnorm

Novartis had been marketing its drug Zelnorm (also called tegaserod maleate and incorrectly called Zelnorm) with stunning success since it was first placed on the market for women in 2002 for irritable bowel syndrome. In August 2004, it was able to expand its market share when Zelnorm was given the additional indication for short-term treatment of chronic constipation in men and women under the age of 65. Last year, Zelnorm was honored as having one of the best prescription drug ads by IAG Research, a company that rates TV ad effectiveness. The “tummies” campaign, which turned women’s bellies into billboards, was credited with boosting sales growth to $561 million in 2006 to relieve IBS. Of course, these kinds of accolades do not come cheap: Novartis spent $325 million in three years marketing Zelnorm, which costs consumers about $200 a month to use as recommended.

  • Last month, the FDA recommended that Zelnorm be removed from the market after reviewing data that found users of Zelnorm experienced heart attacks, strokes, and angina at a rate 7 to 8 times greater than those who took a placebo. To show a correlation between an adverse event and a drug, researchers like to see a 2 to 1 ratio between the incidence of the adverse event in the active group versus the control group. A ratio of 7-1 is off the charts. Novartis is claiming that the incidence rate is the same for the active group taking Novartis as it is for the general population. But unless the placebo the control group was given was a miracle drug, it is hard to figure how that is possible. Did the placebo reduce the risk of stroke, heart attacks, and angina?

Because the FDA asked Novartis to take Zelnorm off the market, as opposed to Novartis making an affirmative choice to remove this potentially life-threatening drug, our lawyers suspect that the data which indicated that Zelnorm could cause serious and even fatal injuries was available to Novartis before Zelnorm was removed from the market. I say “suspect” because no discovery has been conducted. But from my experience with these companies, it is hard not to prejudge. Novartis estimated on its 2007 1st Quarter Conference Call that it would lose $600 million in sales in 2007 as a result of Zelnorm being taken off the market. Analysts predicted this would rise to $1 billion by 2012. If you are looking for a motive, here it is.

What about the fear of lawsuits? Tim Anderson, a Prudential analyst, said that lawsuits and legal costs will be “largely immaterial to a company of (Novartis’) size.” Another analyst added that “only” 1,000 to 2,000 patients suffered these problems while taking the drug. Depressing.

Clearly all of the facts are not yet in as to the details of the risk and whether this drug should have been on the market. Many are patting the back of the FDA saying they are more aggressive about public safety in the post-Vioxx era. But Zelnorm was rejected as too risky last year for a second time by a European Union health advisory panel. This begs the question: what did the FDA not see in Zelnorm that the European Union saw and rejected? (Unfortunately, the fact that Zelnorm has not been approved by the European Union for this Swiss company is unlikely to be admissible should these cases go to trial.)

  • C R

    It is unfortunate that Zelnorm was taken off the market. I read the studies, and am a patient myself. The 7:1 or 8:1 ratio of heart problems on placebo vs. Zelnorm is simply incorrect when one puts it into perspective. If you read the studies on this in relationship to the heart problems (IN the context of the type of patients in the study), then you’ll see that if anything Zelnorm might have beneficial effects on the heart in cases of those with chronic constipation, or IBS. Chronic constipation can cause a host of health problems, and the war between drug companies didn’t help either.

    Is there someone looking at the alternative of NOT having Zelnorm on the market, or looking at the studies – ALL of the studies?

    I would go back on Zelnorm in a heart-beat, as alternatives have not helped whatsoever!

    IN addition, ther are many drugs out there that *DO* cause heart problems, driving unconciously and a laundry list of other problems that can be deadly, yet with a warning in a commerical, they are allowed to stay on the market.

    This medication helps a LOT of people, and people in other countries are using it with no ill effects, in fact quite the opposite… I want to be able to take Zelnorm once again! I was FAR better off with it. The alternatives have not worked, and have affected my quality of life.. Who’s going after those who submitted the inaccurate studies to the FDA to get this medication removed in the first place??? THEY are the ones who should be held responsible for the damages they have done!

  • latoria gaines

    I really need halp with my case of taking tyhe Zelnorm medication on March 15, 2007 which lead to serious life long problems.

  • latoria gaines

    I really need halp with my case of taking the Zelnorm medication on March 15, 2007 which lead to serious life long problems.

  • Ger

    I’m a 30-something-year-old who survived a massive Heart Attack on Zelnorm without other risk factors… not particularly motivated to take Zelnorm again! There’s got to be a better way to deal with IBS than risk death!

Contact Information