IBS Patients - Zelnorm® is Back

Robert W. Griffith, MD

Irritable bowel syndrome (IBS) patients with constipation-type IBS suffered a setback in March of this year when the FDA asked Novartis to withdraw the drug tegaserod (Zelnorm®) because of an increased risk for cardiovascular events. The FDA has now pointed out that the drug may still be used in patients who have no other treatment options. Specifically, IBS patients with constipation and chronic idiopathic constipation patients under 55 and without heart problems can be given Zelnorm under what is technically called a 'treatment IND'.

The FDA press release contains the following notice for doctors: " Physicians with IBS-C [IBS-with-constipation] or CIC [chronic idiopathic constipation] patients who meet the IND criteria should contact Novartis at 888- 669-6682 or 866-248-1348. Those who do not qualify for the Zelnorm treatment protocol may contact FDA's Division for Drug Information about other options at 888-463-6332."

Good news for those with intractable constipation.

Source
HealthandAge Blog

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