ROCKVILLE, Md. -- Tegaserod (Zelnorm), the irritable bowel syndrome and constipation drug pulled from the market last spring, will make a limited return under an FDA plan that permits its use in certain symptomatic women younger than 55.
ROCKVILLE, Md., July 27 -- Tegaserod (Zelnorm), the irritable bowel syndrome and constipation drug pulled from the market last spring, will make a limited return under an FDA plan that permits its use in certain symptomatic women younger than 55.
The FDA said today it will permit use of the drug under an investigational new drug (IND) protocol to treat IBS with predominant constipation and chronic idiopathic constipation in women in "critical need" whose physicians "decide the drug is medically necessary."
Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of tegaserod.
The announcement does not, however, signal a return to the aggressive direct-to-consumer "talking tummy" campaign that fueled million in tegaserod sales in 2006.
Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, said the drug "will remain off the market for general use."
Tegaserod can only be prescribed for patients who meet "strict criteria and have no known or pre-existing heart problems," Dr. Galson said.
Last March 30, the FDA said that tegaserod's maker, Novartis, agreed to withdraw tegaserod after a meta-analysis revealed an apparent increase in ischemic events in those taking the drug.
The pooled analysis of data from 29 placebo-controlled trials identified 13 ischemic events among 11,614 patients treated with tegaserod compared with a single case among 7,013 placebo-treated patients. The rate of ischemic events was 0.11% in the tegaserod patients versus 0.01% in the placebo group, a difference that Novartis said was not statistically significant.
One of the 13 events was fatal versus no ischemic deaths in the placebo patients.
Tegaserod was the only FDA-approved treatment for IBS with predominant constipation, and when the FDA announced the withdrawal it said it recognized that the action would cause clinical management problems for patients who used the drug for that indication.
John K. Jenkins, M.D., director of the FDA's Office of New Drugs at the Center for Drug Evaluation and Research, said the agency would work with the drug maker to set up an IND program to permit restricted access to tegaserod. Today's announcement was the culmination of that four-month planning process.