Statin drugs are dangerous
WASHINGTON, DC. Well over a thousand cases of rhabdomyolysis (an often fatal muscle disease) caused by the ingestion of statin drugs (atorvastatin [Lipitor], simvastatin [Zocor], lovastatin [Mevacor], pravastatin [Pravachol]) have been reported. Now the FDA has issued a warning not to take more than 20 mg/day of simvastatin if also taking amiodarone since doing so will markedly increase the risk of rhabdomyolysis. The warning also applies to the combination of simvastatin and ezetimibe (Vytorin) and the combination of simvastatin and extended-release niacin (Simcor). The FDA press release states that:
Editor's comment: If a combination of amiodarone and 20 mg/day or more of simvastatin is dangerous enough to require a warning, how dangerous is amiodarone plus 10 mg/day? Who knows? The FDA does not seem to. What is perhaps more disturbing is that the FDA has no data regarding the effect of amiodarone dosage on rhabdomyolysis incidence when combined with simvastatin. Could simvastatin combined with a loading dose of amiodarone (800 – 1600 mg/day) be vastly more dangerous than the combination of simvastatin and an amiodarone maintenance dose of 200 – 400 mg/day? Nobody knows, so afibbers on or contemplating amiodarone should be very careful about also taking statin drugs, particularly simvastatin.
- The risk of rhabdomyolysis is increased when higher doses of simvastatin are administered with amiodarone. The precise mechanism is unknown, but is related to the fact that amiodarone inhibits the cytochrome P450 3A4 (CYP3A4) enzyme. This is the same enzyme that metabolizes simvastatin. Prescribers should consider use of another statin for patients taking amiodarone, or initiating amiodarone therapy, who require simvastatin doses greater than 20 mg daily to meet their lipid goals.
- Rhabdomyolysis has been reported with all statins. Predisposing risk factors for rhabdomyolysis include advanced age (greater than 65 years), uncontrolled hypothyroidism, and renal impairment.
- The FDA does not have data on how varying the dose of amiodarone in patients taking simvastatin affects the risk of developing rhabdomyolysis.
Editor's comment: If a combination of amiodarone and 20 mg/day or more of simvastatin is dangerous enough to require a warning, how dangerous is amiodarone plus 10 mg/day? Who knows? The FDA does not seem to. What is perhaps more disturbing is that the FDA has no data regarding the effect of amiodarone dosage on rhabdomyolysis incidence when combined with simvastatin. Could simvastatin combined with a loading dose of amiodarone (800 – 1600 mg/day) be vastly more dangerous than the combination of simvastatin and an amiodarone maintenance dose of 200 – 400 mg/day? Nobody knows, so afibbers on or contemplating amiodarone should be very careful about also taking statin drugs, particularly simvastatin.
The AFIB Report, Forum and Database do not provide medical advice. Do not attempt self-diagnosis or self-treatment based on our reports.
Donate Today!
Please donate to The AFIB Report, using one of the two buttons below.
A third donation method, beyond choosing either the Donate with PayPal or Donate with Credit/Debit card described elsewhere on this site, is for those who prefer to directly mail a check or money order to our business address at: The AFIB Report, A Non-Profit 501(c)(3) Corporation, C/O Shannon Dickson, P.O. Box 1016, Sedona, Arizona 86339. Any of the three donation options are fine with us based on each donor's preference, and with our sincere gratitude!
A third donation method, beyond choosing either the Donate with PayPal or Donate with Credit/Debit card described elsewhere on this site, is for those who prefer to directly mail a check or money order to our business address at: The AFIB Report, A Non-Profit 501(c)(3) Corporation, C/O Shannon Dickson, P.O. Box 1016, Sedona, Arizona 86339. Any of the three donation options are fine with us based on each donor's preference, and with our sincere gratitude!
The AFIB Report, A Non-Profit Tax-Exempt 501(c)(3) Corporation
Learn