No black box warning on record for Simvastatin

As of the latest FDA labeling reviewed, Simvastatin (simvastatin) does not carry a black box warning. Standard warnings and precautions still apply — see the full Simvastatin medicine page for the complete safety profile.

Other warnings & precautions

80mg Dose Restriction: The FDA in 2011 severely restricted the 80mg dose of simvastatin due to a 10-fold higher risk of myopathy compared to lower doses. The 80mg dose should ONLY be used in patients who have been on it for ≥12 months without evidence of myopathy. New patients should not be started on 80mg; if patients require the LDL-lowering equivalent, use atorvastatin or rosuvastatin instead.
Myopathy and Rhabdomyolysis: All statins can cause myopathy. Risk is substantially dose-dependent for simvastatin and dramatically increased by CYP3A4 inhibitors (which many cardiac patients take — amiodarone, diltiazem, verapamil). Patients should report unexplained muscle pain, tenderness, or weakness. If CK is markedly elevated or rhabdomyolysis is suspected, discontinue immediately.
Pregnancy Category X: Statins are absolutely contraindicated in pregnancy and breastfeeding — cholesterol synthesis is required for fetal development. Women of childbearing age should use reliable contraception during statin therapy.
Liver Monitoring: Liver function tests should be performed before starting therapy. Persistent significant transaminase elevation (>3x ULN) warrants discontinuation.

No black box warning on record for Simvastatin

Other warnings & precautions

80mg Dose Restriction: The FDA in 2011 severely restricted the 80mg dose of simvastatin due to a 10-fold higher risk of myopathy compared to lower doses. The 80mg dose should ONLY be used in patients who have been on it for ≥12 months without evidence of myopathy. New patients should not be started on 80mg; if patients require the LDL-lowering equivalent, use atorvastatin or rosuvastatin instead.
Myopathy and Rhabdomyolysis: All statins can cause myopathy. Risk is substantially dose-dependent for simvastatin and dramatically increased by CYP3A4 inhibitors (which many cardiac patients take — amiodarone, diltiazem, verapamil). Patients should report unexplained muscle pain, tenderness, or weakness. If CK is markedly elevated or rhabdomyolysis is suspected, discontinue immediately.
Pregnancy Category X: Statins are absolutely contraindicated in pregnancy and breastfeeding — cholesterol synthesis is required for fetal development. Women of childbearing age should use reliable contraception during statin therapy.
Liver Monitoring: Liver function tests should be performed before starting therapy. Persistent significant transaminase elevation (>3x ULN) warrants discontinuation.

Simvastatin Black Box Warning

No black box warning on record for Simvastatin

Other warnings & precautions

Simvastatin Black Box Warning

No black box warning on record for Simvastatin

Other warnings & precautions