Novartis, the manufacturer of Zelnorm, has notified the FDA that they will no longer provide Zelnorm (tegaserod maleate) under a treatment investigational new drug application (T-IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55.
Novartis has agreed to continue to supply Zelnorm for use in emergency situations. Requests for Zelnorm for this purpose may be made to the FDA which in turn authorizes shipment of the drug by the manufacturer.
An emergency situation is defined as one that is immediately life-threatening or serious enough to qualify for hospitalization. FDA may deny authorization, even in life-threatening situations, if available evidence fails to provide a reasonable basis for concluding that Zelnorm may be effective for the intended use, or if exposure to Zelnorm would pose an unreasonable or a significant additional risk to patients. The following conditions are cause for denial of authorization:
- prior history of heart attack or stroke
- unstable angina
- age greater than 55 years
- suicidal ideation
Physicians with patients who may qualify for treatment with Zelnorm for emergency use may contact FDA’s Division for Drug Information about the emergency IND process and can download the Zelnorm Single Patient IND Packet here. To contact DDI during regular business hours (8:00 am – 4:30 pm Eastern Time, Monday – Friday) call 301-796-3400 or 855-543-3784 (email: email@example.com). Outside of regular business hours contact the CDER Emergency Coordinator at 301-796-9900 or 301-796-2210 (email: firstname.lastname@example.org).
On March 30, 2007, the FDA asked Novartis to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo).
On July 27, 2007, the FDA announced that it was permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND).