Voluntary Recall Of Zelnorm Issued After Prompt By FDA

M. Brandon Smith
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Posted by M. Brandon SmithMarch 31, 2007 11:02 PM

The sale of Zelnorm, (tegaserod maleate) approved in 2002 for treatment of irritable bowel syndrome with constipation, has recently been suspended by its manufacturer, Novartis, after the drug has been linked to a significant number of cardiovascular risks. This decision was made after the United State Food and Drug Administration found the drug can lead to increased occurrences of heart attack, stroke and serious chest pains. Doctor's with patients taking Zelnorm are being asked by the FDA to work with their patients to find other suitable replacement medications and therapies.

Earlier this year, 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 analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.

The FDA has told Novartis it would consider allowing a limited reintroduction of Zelnorm "if a population of patients can be identified in whom the benefits of the drug outweigh the risks," the agency said.

4 Comments

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Barbara Hill
Posted by Barbara Hill
April 02, 2007 6:12 PM

I am so disappointed about taking Zelnorm off the market. It works great for me and now don't know what to do. I have been pain free since starting and am dreading the return of the awful pain, bloating and all else that happens.

Rochelle
Posted by Rochelle
April 02, 2007 11:01 PM

Like wise disappointed in the recall of Zelnorm it was a great help to me over the past few years. But with heart disease already in my family I am not willing to take the risk of increasing my chances of having a heart attack.

Shirley Mamer
Posted by Shirley Mamer
April 29, 2007 1:37 AM

I too am very disapointed that Zelnorm is off the market, I have taken it for the past 6 years with no trouble & it made my life so much easier to live with IBS on a daily basis. I am now searching for an alternative, finding nothing . I am not sure what I will do . PLease if anyone has any ideas please email me , I am starting to try a natural herb ( Intestinew, & Fibresmart & probiotic) I hope they will work but nothing will work like Zelnorm did.

Please bring it back

Thank you

Shirley

Charlotte
Posted by Charlotte
April 01, 2009 5:35 PM

I used Zelnorm for a couple of years and loved it. It was the only medicine that gave me relief. I have been very unhappy and miserable since this was taken off the market. My doctors have done test after test and medicines, and nothing seems to help. I really wish the FDA would reconsider putting this back on the market for those in real need for this product. There were no side affects for me and I'm sure for a lot of people.

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