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Combining Simvastatin with Amiodarone Carries Risk, FDA Reminds Clinicians
The FDA has issued a reminder that combining more than 20 mg daily of simvastatin (Zocor, Vytorin, Simcor) with amiodarone (Cordarone, Pacerone) increases the risk for rhabdomyolysis.
Although the possible hazard was added to simvastatin's label in 2002, the agency says it continues to receive reports of rhabdomyolysis associated with the combination.
The FDA notes that while all statins (with or without amiodarone) carry increased risk for rhabdomyolysis, the hazard is more pronounced when simvastatin is combined with amiodarone. The risk is related to the fact that amiodarone inhibits an enzyme (CYP3A4) that metabolizes simvastatin more extensively than other statins.
LINK(S):
FDA alert (Free)
Associated Press story (Free)
Published in Physician's First Watch August 11, 2008
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