FDA Advises Against 80-mg Simvastatin DoseLast updated: Jun 09, 2011
The Food and Drug Administration (FDA) just announced that patients taking the 80-mg (highest) dose of simvastatin (Zocor®) should be switched if they are taking any of the following drugs or combinations:
- Simvastatin 80 mg
- Gemfibrozil any dose with simvastatin any dose
- Amlodipine (Norvasc) with simvastatin >20 mg
- Ranolazine (Ranexa) any dose with simvastatin >20 mg
- Amiodarone any dose with simvastatin >10 mg
- Verapamil any dose with simvastatin >10 mg
- Diltiazem any dose with simvastatin >10 mg
Because Simcor and Vytorin both contain simvastatin,
patients taking either of these medications should check with their doctor.
In an announcement on June 8, 2011, the FDA noted that data show a small risk of myopathy, a type of muscle pain and weakness, for patients who take the 80-mg simvastatin dose compared with those taking the 20-mg dose (0.9% of participants compared with 0.02%). The labeled risk is 0.53%. The FDA noted that research also showed that a small percentage (0.4%) of the 80-mg group developed rhabdomyolysis, a more severe condition involving the breakdown of muscle fibers and release of a kidney-damaging protein into the blood.
Although the FDA reassured patients that "the risk for an individual is tiny," they urged patients taking simvastatin to talk with their doctors about switching or lowering the dose of their medication.
The FDA advises patients not meeting their low-density lipoprotein (LDL) goals ask their doctors about taking a different statin instead of taking a higher dose of simvastatin.
Summit Medical Group recommends that patients continue taking their medications as prescribed
until they have talked with a doctor.