Natrecor Linked to Increased Death Rates and Kidney Problems

Medical Journals Raised Questions about Safety of Natrecor

Natrecor has been reported to increase kidney problems and death rates among patients in recent editions of Circulation and The Journal of the American Medical Association (JAMA).  Last week, Johnson & Johnson announced that it had agreed with the U.S. FDA to revise labeling for Natrecor to include the data underlying those medical journal reports.

Separately, in early May 2005 the cardiologists at Cleveland Clinic recommended that the use of Natrecor be banned or severely limited at its facilities.  The Cleveland Clinic's formulary committee, however, voted on May 4 to continue Natrecor use but under eight restrictive guidelines.  Essentially, the Cleveland Clinic committee recommended that Natrecor be prescribed by cardiologists, or top intensive care doctors, and only in its recommended dosage on congestive heart failure patients admitted to the hospital whose medical condition has rapidly deteriorated.

Natrecor is approved to treat severe cases of acute heart failure, which typically requires hospitalization.  Natrecor, however, has been widely used in outpatient clinics where patients arrive for regular infusions, also.

Cleveland Clinic drug-policy decisions are significant because those decisions often set precedent for the nation's other hospitals, or get the attention of the FDA.  For example, in December 2004 the Cleveland Clinic took the lead in banning the painkiller Bextra; this was several months before the FDA asked Pfizer to withdraw Bextra from the U.S. market.

Natrecor, made by Johnson & Johnson subsidiary Scios Inc. is given intravenously and has been used by more than 600,000 patients in the U.S. since it was approved by the FDA in 2001.  Johnson & Johnson maintains that Natrecor is safe when used correctly.

(Posted by: Tom Lamb)