Novartis Further Restricts Use of Zelnorm

Due to unstated reasons, Swiss drug maker Novartis has further limited distribution of Zelnorm, the only FDA-approved drug that treats IBS-related constipation. The drug will be available only to those patients who are gravely ill. In 2007, Novartis and the FDA agreed to restrict the use of Zelnorm because of increased risk of heart attack and stroke. With the new restrictions in place, doctors will have to request approval from the FDA to prescribe the drug. The FDA reserves the right to deny access to the drug, based on factors that include age and medical history. Studies are being done on a drug called Amitiza to determine if it can effectively and safely treat IBS-related constipation. Reuters, April 2, 2008
2008-04-12 11:17:37