FDA And Health Canada Had Zelnorm Removed From Respective Markets In March 2007 Due To Concerns About Cardiovascular Safety
(Posted by Tom Lamb at DrugInjuryWatch.com)
In November 2008 a national class action was filed against Novartis Pharmaceuticals Canada Inc., seeking damages on behalf of all Canadians who ingested the medication Zelnorm (tegaserod) which was used by patients who had severe constipation or irritable bowel syndrome (IBS).
From a November 3, 2008 press release issued by one of the law firms that filed this Zelnorm class action lawsuit in Canada:
Zelnorm was used for the symptomatic treatment of irritable bowel syndrome (IBS) and was marketed in Canada between March, 2002 and March, 2007 when sales were suspended at the request of Health Canada. The basis for this request was stated by the defendant to be the results of a retrospective analysis of pooled clinical data that reflected a significant increased incidence of cardiovascular events in persons taking Zelnorm.
A November 5, 2008 newspaper article, "Zelnorm: Woman blames drug company for contributing to heart attack", tells us about the proposed representative plaintiff in the Canadian Zelnorm class action, Trudy Metzger of Elmira, Ontario. In November of 2006, Mrs. Metzger was a healthy and active mother of five when, two days before her 37th birthday, she suffered a severe heart attack. According to this news report, Mrs. Metzger had been taking Zelnorm for about five months prior to her heart attack.
Almost nine months later, however, a new medical journal article suggests that Zelnorm might not cause an increased risk of heart attacks like the one Mrs. Metzger suffered.
The July 15, 2009 edition of the Journal of Cardiovascular Pharmacology and Therapeutics there is a report, "Lack of Association of Tegaserod With Adverse Cardiovascular Outcomes in a Matched Case-Control Study.", that reassesses the cardiovascular safety of Zelnorm (tegaserod).
From the Abstract for this July 2009 medical journal article:
In March 2007, the US Food and Drug Administration (FDA) suspended its use citing increased cardiovascular (CV) events in clinical trials. However, there is no known mechanistic basis for an adverse CV effect. To reassess the CV safety of tegaserod, teagaserod-treated patients (pts) in the Intermountain Healthcare database were identified (n = 2603), matched 1:6 with untreated (n = 15,618) patients by age, sex, and date of tegaserod initiation, and followed for an average of 2.5 years.... This large epidemiologic study failed to confirm a reported large event differential for tegaserod that was noted incidentally in a clinical trials database, suggesting that the prior observation may have been due to chance.
For more about this March 2007 Zelnorm recall in the U.S., see my earlier article: "Constipation Medication Zelnorm Linked To Apparent Increased Risk Of Heart Attacks And Strokes".
We will continue to watch for medical journal articles about safety studies concerning Zelnorm and monitor the progress of Zelnorm lawsuits filed on behalf of patients who suffered a heart attack or stroke while using Zelnorm.