J&J to pull Propulsid from US market after serious CV events
Johnson & Johnson's subsidiary Janssen Pharmaceutica says it is tocease marketing Propulsid (cisapride) in the USA, effective July 14, following serious cardiovascular events associated with the drug's use. The company has not immediately withdrawn the product, to "provide adequate time for patients and physicians to make alternative treatment decisions," noted a US Food and Drug Administration Talk Paper.
J&J will continue to provide the drug under a "limited-access" program, which will be initiated from May 1 for patients who meet specific eligibility criteria and for whom other therapies are ineffective. The company says it intends to contact other regulatory agencies to discuss the future of the drug in other global markets.
Shares in J&J closed down almost 10% ($7.75) on March 24 on a volume of more than 19 million traded.
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