Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

Zocor (simvastatin): Label Change - New Restrictions,
Contraindications, and Dose Limitations Simvastatin sold under the
brand-name Zocor, as a single-ingredient generic product, and sold in
combination with ezetimibe as Vytorin and in combination with niacin
as Simcor

AUDIENCE: Family Practice, Cardiology, Pharmacy

ISSUE: FDA notified healthcare professionals that it is recommending
limiting the use of the highest approved dose of the
cholesterol-lowering medication simvastatin (80 mg) because of
increased risk of muscle damage. Patients taking simvastatin 80 mg
daily have an increased risk of myopathy compared to patients taking
lower doses of this drug or other drugs in the same class. This risk
appears to be higher during the first year of treatment, is often the
result of interactions with certain medicines, and is frequently
associated with a genetic predisposition toward simvastatin-related
myopathy. The most serious form of myopathy, called rhabdomyolysis,
can damage the kidneys and lead to kidney failure which can be fatal.
FDA is requiring changes to the simvastatin label to add new
contraindications (should not be used with certain medications) and
dose limitations for using simvastatin with certain medicines.