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Simvastatin 80 mg and New FDA Restrictions

I’ve been pretty aggressive over the last few years at getting patients onto generic statins when their cholesterol can be controlled appropriately and have a number of patients on simvastatin 80 mg.  The branded statins, like Lipitor and Crestor are at least as effective as simvastatin 80 mg, but cost far more, and simvastatin has seemed to be the most potent of the available inexpensive generic statins.  Pravastatin and lovastatin are generic alternatives, but are considerably less effective at lowering the LDL cholesterol in patients who need a major LDL lowering drug.

As with any individual physician my “n” or number of patients treated is small enough that it is not possible from personal experience to detect issues like the increased incidence of myopathy and rhabdomyolysis noted with simvastatin 80 mg, or with lower doses used in patients on meds like amlodapine, diltiaziem, and others.

As I noted in an earlier post generic Lipitor is expected to lose its patent this year, and generic atorvastatin should be available.  This is likely to obviate the need for higher doses of simvastatin for lipid control in patients with very high cholesterol.  Since the earlier warnings I’ve been using lower dose simvastatin and avoiding simvastatin 80 mg in most patients, but this recent evidence presses the need to avoid simvastatin 80 mg even more.  For the press release by the FDA see:

 

FDA Drug Safety Communication:  New restrictions, contraindications, and dose limitations for Zocor (simvastatin)  to reduce the risk of muscle injury

Safety Announcement

Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
Simvastatin Dose Limitations
Relative LDL-lowering Efficacy of Statin and Statin-based Therapies
References


 

 

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