WASHINGTON (Reuters) – U.S. health officials warned the public on Friday about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone.
The Food and Drug Administration said it continued to receive reports of rhabdomyolysis, a type of muscle injury that can lead to kidney failure or death, despite a 2002 warning about combining the drugs.
Simvastatin is an ingredient in Merck & Co’s Zocor and Abbott Laboratories Inc’s Simcor, and is sold generically. It also is one of two components in Merck and Schering-Plough Corp’s Vytorin.
Amiodarone is an ingredient in Wyeth’s Cordarone and is also sold generically.
All drugs in the statin class of medicines, which includes simvastatin, carry a potential risk of rhabdomyolysis.
But compared with other statins, the risk is “more pronounced” when simvastatin is given with amiodarone, the FDA said. The risk increased with simvastatin doses greater than 20 milligrams per day.
“Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone,” the FDA said in a notice on its website.
(Reporting by Lisa Richwine, editing by Gerald E. McCormick, Dave Zimmerman)