Zelnorm: Irritable Heart Syndrome
3 CommentsBy Ed Silverman // March 30th, 2007 // 12:26 pm
This isn’t a gas for Dan Vasella. At the urging of the FDA, Novartis is withdrawing Zelnorm, which is used to treat irritable bowel syndrome, due to a high risk of developing heart attacks, strokes and chest pain.
This move comes after Novartis told the FDA on Feb. 22 about the results of a review 29 short-term clinical trials, which was undertaken at the request of Swiss regulatory authorities who became interested in Zelnorm side effects in 2004. The drugmaker and the FDA met on Wednesday, and the FDA yesterday requested Novartis make a ‘voluntary withdrawal.’
The review showed that only 0.1 percent of 11,600 Zelnorm patients, or 13 people, experienced serious heart problems; one died. Of 7,000 placebo patients, 0.01 percent of the patients, or just one person, reported cardiovascular problems. In medical terms, the absolute risk of a serious problem was small, but the relative risk was high.
In a statement, Novartis says the 13 people had cardiovascular risk factors and that there was no causal relationship demonstrated between Zelnorm and the cardiovascular side effects. The FDA says of those 13, eight had previous cardiovascular events and five had risk factors.
“We haven’t proven causality but found the signal worrisome enough,” says John Jenkins, the director of the FDA’s office of new drugs, adding that the agency is “looking into the timeline” to better understand when Novartis learned of the side effects. The FDA may reconsider allowing Zelnorm on the market because its the only drug for treating irritable bowel syndrome constipation in women. Zelnorm rang up $560 million in sales last year.
Zelnorm has generated serious side-effect reports for years. The FDA issued warnings in 2004 due to serious diarrhea and ischemic colitis. Moreover, some doctors criticized Zelnorm TV ads for portraying slim, glamourous women, but ads didn’t state the very unglamorous side effect that the drug “increases the movement of stools (fecal matter) through the bowels.”
FDA public health advisory yesterday;
FDA warning in 2004;
Novartis statement. [tags]Irritable Bowel Syndrome, Novartis, Zelnorm[/tags]
Karen
It’s a good thing Sen. Kennedy is busy going after compounding pharmacies. Nevermind the fact that federally regulated Big-Pharma is currently killing people everyday. Now the FDA also wants jurisdiction of compounding pharmacy. The FDA should concentrate harder on its current job of approving SAFE “Big-Pharma-ceuticals!”
swissinsider
It is possible Zelnorm was promoted for IBS in anyone, not only women and not only for severe cases as second or third line therapy, which it should be. The drug was approved by FDA and other countries’ reg. agencies only for use in women but as it usually hapens with big pharma, Novartis pushed it beyond the official indication. Thus we had so may people take it and the severe side effects showed up.
When introduced, Zelnorm was predicted to become a mega drug for Novartis that would sell in billions so they emplyed their marketing machnery to rech those goals. So instead of being used only in those cases of IBS that justified it (very expensive and by now shown as dangerous drug) it was used as “candy” by overexposed doctors.
In reality, Zelnorm is just an expensive lexative that sometimes works better in some patients. In genearl doctors have not been impressed with results that were promised by Novartis.
Are they going to stop selling it worldwide or just in those countries that order them? Lets watch.
Mayer
As a physican and attorney I recommend that everyone who wants to avoid the serious side effects of Zelnorm look at natural alternatives. FOS is an inexpensive simple natural nondigestable suger that has been shown to be a great treatment for all types of constipation. Of course no one can patent it, so no big money for big Pharma.
There are so many simple natural alternatives for elevated cholesterol,elevated blood pressure, muscle and joint pain, digestive issues etc. Just use the internet and study.