Sunday, August 12, 2007

Zelnorm is back

On a limited basis. If you found this drug to be a moving experience for your chronic constipation, the FDA has created a loophole through which you can get back on it.

This is the IND option, or investigational new drug protocol program, which states:

In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.

So while Zelnorm was yanked from the market in March when its use was linked to increased risk of ischemic cardiovascular outcomes, youngoid women under 55 with constipation from IBS or CIC (chronic idiopathic constipation) can apply for a waiver.

Big-time constipation is a real show-stopper. If you miss your Zelnorm, ask your MD to call the manufacturer at 888-669-6682 to open up options for your bowel woes.

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