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FDA Adds More Warnings for Lipitor, Crestor, and Zocor

MedpageToday

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WASHINGTON -- Statins may cause drug-drug interactions for patients taking drugs to treat HIV/AIDS or hepatitis C, according to a new statin warning from the FDA.

The agency singled out atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor) for the new warnings and restated a warning about mixing lovastatin (Mevacor) with HIV and HCV drugs.

Today's FDA safety communication follows label changes announced Tuesday that added cautions about new onset diabetes and transient memory problems for users of any of the cholesterol-lowering drugs in the statin class.

The FDA said that protease inhibitors taken with atorvastatin, rosuvastatin, simvastatin, or lovastatin increase the concentration of statins in the blood, which increases the risk for muscle injuries, including risk for rhabdomyolysis, which can cause permanent damage to the kidneys.

Specifically, the agency said atorvastatin is contraindicated with tipranavir plus ritonavir, and telaprevir and should be used with caution -- at the lowest effective dose -- among patients taking lopinavir plus ritonavir.

For patients taking darunavir plus ritonavir, fosamprenavir, forsamprenavir plus ritonavir, or saquinavir plus ritonavir, the atorvastatin dose should be limited to 20 mg daily.

In patients taking nelfinavir, daily atorvastatin should not exceed 40 mg.

Rosuvastatin should be limited to 10 mg daily in patients taking atazanavir with or without ritonavir or lopinavir plus ritonavir.

The FDA said simvastatin -- like lovastatin -- is contraindicated in patients taking "HIV protease inhibitors, boceprevir or telaprevir."