The US Food and Drug Administration (FDA) announced today that it is permitting the restricted use of Zelnorm under what is known as an investigational New Drug (IND) Protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
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. These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of the drug. Zelnorm will remain off the market for general use – Learn Why Here and Here.
Medical professionals with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888-669-6682 or 800-QUI-NTILE.
Those who do not qualify for the Zelnorm treatment protocol (see above for criteria) can contact the FDA’s Division for Drug Information about other options at 888-463-6332.
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