Eight months after Novartis trumpted plans to return Zelnorm as part of a restricted access program, the drugmaker is yanking the med altogether, according to info on theFDA web site. The med, which was designed to treat irritable bowel syndrome, was withdrawn in March 2007 due to a high risk of developing heart attacks, strokes and chest pain.
The Swiss drugmaker was stung by the need to pull Zelnorm, which rang up $560 million in sales in 2006, particularly in the face of pipeline problems and the failure to win approvals for new meds. So Novartis made a deal with the FDA to provide Zelnorm for a limited number of patients, since the drug was the only approved treatment for IBS.
Now, though, Novartis will only make Zelnorm available to patients whose condition is life-threatening or who are so sick they require hospitalization. The decision to curb the use was a voluntary, according to the FDA. Could Novartis have new data about Zelnorm? We're waiting for a comment. But docs who want the drug will have to ask the FDA for permission to authorize any shipment from Novartis.
"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 agency writes in its notice, adding that the drug may be denied to anyone with a history of heart problems, diabetes, obesity, depression or are older than 55.