FDA Determines Popular IBS Drug should be pulled off the Market

Avatar Editorial Posted by lisag0315 493 days ago

After suffering with chronic stomach problems for 3 years, I was 104 pounds, depressed and desperate for help I was diagnosed with IBS by a Gastroenterologist following the diagnosis 18 months ago, I began taking Zelnorm. My life changed immediately, I was able to return to normal activities and begin to really enjoy life again.

Without even giving consideration to the millions of IBS sufferers like me... on March 31, 2007 the FDA recommended a voluntary withdrawal of Zelnorm in the US due to potential heart problems however, the heart problems which occurred in .1 percent of the patients followed where only in patients with previous heart conditions. The results of the clinical trial where are follows:

Analysis of clinical trial data identified a small imbalance that was statistically significant in the number of cardiovascular ischemic events in patients taking Zelnorm. These events included heart attack, stroke and unstable angina. They occurred primarily in patients who had pre-existing cardiovascular disease and/or cardiovascular risk factors. There is no demonstrated causal relationship between Zelnorm and these events.

The drug is available in other countries under the name Zelmac. It is approved in Switzerland and Australia as well as 52 other countries.

I will be forced to travel to Mexico to buy the medication which provided me relief when nothing else worked.
Location: USA

1 Comment | Tags: zelnorm ibs fda | Category: Federal | Add this link to... | Tell a friend

Comments


  • Avatar | written by admin 492 days ago Rating: 0 | Rate comment: + -

    So, according to the data I see:

    "Safety data from 29 clinical trials involving over 18,000 patients showed that cardiovascular ischemic events occurred in 13 out of 11,614 patients treated with Zelnorm (0.11%), compared with one case in 7,031(0.01%) patients treated with a sugar pill they thought was Zelnorm. All patients affected had pre-existing cardiovascular disease and/or cardiovascular risk factors."

    Yet, I see drugs advertised on television that seem to have much worse side affects.

    Is this data statistically significant? What real sufferers of IBS do now?

    Also, if you look to the right, you see AdSense ads for lawyers ready to sue. Typical.


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