The drug Zelnorm, manufactured by Novatis, was taken of the market in March because of a high risk of heart attacks, stroke, and chest pain.
But now the FDA is allowing the irritable bowel syndrome drug to become available again, but only for a restricted access program. Zelnorm will remain off the market for the general public.
The program is for women in the US under 55 years of age who suffer from IBS with constipation or chronic idiopathic constipation, and for whom no other treatment has provided satisfactory relief, or patients who had satisfactory improvement of their symptoms with prior Zelnorm treatment.
The drug is back on the market because of complaints from doctors and patients of the Zelnorm's "marketing suspension". But now there are special requirements that have to be met to become a part of the drug's program. Users cannot have any known or pre-existing heart problems and must be in dire need of the drug.
The drug was removed because a review showed that Zelnorm users had a higher incidence of cardiovascular problems than did participants taking the placebo. Novartis claims that there is not causal relationship between Zelnorm and heart attack.