The Simvastatin Saga: Review of the FDA Drug Safety Warnings
On June 8, 2011, with the release of the FDA warnings, the simvastatin sales bonanza was doomed. Here are the highlights.
High-Dose Simvastatin: Prescribe 80 mg No More
The FDA said no "new" prescriptions for high-dose simvastatin (80 mg). The FDA says that the 80 mg is satisfactory if patients have been on it for a year with no evidence of myopathy. However, to me, with what we know now, continuing to prescribe the 80-mg dose even in patients who had been stable is like hiring a known child molester as a babysitter.[4,6]
Restrictions on Intermediate- and Low-Dose Simvastatin: Is 40 mg the New 80 mg?
Not necessarily. There are more restrictions:
New: No more than 20 mg for patients taking amlodipine (Norvasc®) and ranolazine (Ranexa®); and
Restrictions for Simvastatin at Any Dose
The FDA has mandated drug labeling changes warning that simvastatin is contraindicated in patients on gemfibrozil; antifungal medications including itraconazole (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafil®); antibiotics such as erythromycin, clarithromycin, telithromycin (Ketek®); and HIV protease inhibitors, nefazodone, cyclosporine, and danazol.[4,6]
This information is not totally new. In 2004, when the A to Z trial was published in JAMA, the Cleveland Clinic's Dr. Steven Nissen's editorial expressed his concerns about increased rates of myopathy in patients on simvastatin. The most recent study to cast dispersions on simvastatin was SEARCH published in TheLancet in 2010, which linked simvastatin 80-mg doses of simvastatin to increased risk for myopathy.[4,8] Why the FDA didn't act sooner is not clear, but the word is out now. Simvastatin concerns are in the public domain. Patients know about them, and they depend on us to clean up their medication regimens.
Medscape Internal Medicine © 2011 WebMD, LLC
Cite this: Sandra A. Fryhofer. Switching From Simvastatin 80 mg: How to Shop for Statins - Medscape - Aug 12, 2011.