FDA permits restricted use of Novartis' Zelnorm

The US Food and Drug Administration has permitted restricted use of Swiss drug major Novartis' withdrawn drug Zelnorm (tegaserod maleate) under a treatment Investigational New Drug protocol for irritable bowel syndrome with constipation (IBS-C) and chronic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 IND guidelines, when no comparable or satisfactory alternative drug or therapy is available. In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide it is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm, the agency noted.

On March 30, the FDA asked Novartis to suspend its US marketing and sales of Zelnorm because a safety analysis found a higher chance of heart attack, stroke and unstable angina in Zelnorm patients versus those on placebo (Marketletter April 9). At that time, the agency indicated that there might be patients for whom the benefits of the drug outweigh the risks."These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," said Steven Galson, Director of the FDA's Center for Drug Evaluation and Research. "Zelnorm will remain off the market for general use," he added.