FDA to Allow Limited Use of Zelnorm

The FDA has decided certain patients will be able to take Novartis’ Zelnorm, despite the fact that Novartis withdrew the drug from the market at the agency’s request in March due to an increased risk of cardiovascular events.

Novartis had conducted an analysis of clinical trial data, which found that Zelnorm (tegaserod maleate) raised the risk of heart attack and stroke compared with placebo, prompting the withdrawal. However, no causal relationship between Zelnorm and cardiovascular ischemic events has been demonstrated, according to Novartis.

At the time of the withdrawal, the FDA said there might be patients for whom the benefits of Zelnorm outweigh the risks and for whom no other treatment options are available. After working with Novartis, the FDA has established an investigational new drug (IND) protocol that would allow certain patients to be treated with Zelnorm.

The IND protocol for Zelnorm stipulates that women under 55 whose physicians decide the drug is medically necessary may be prescribed Zelnorm to treat irritable bowel syndrome combined with constipation or chronic idiopathic constipation, the agency said. Patients will have to sign consent materials to ensure they are informed of the drug’s risks.