The Medical Letter on Drugs and Therapeutics
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1386
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Statin Label Changes

Citing some recent reports, the FDA has announced changes in the safety labeling of all HMG-CoA reductase inhibitors (statins).1

HEPATOTOXICITY — Routine monitoring of hepatic enzymes is no longer recommended. Serious hepatic injury has been rare, and monitoring was not helpful in detecting or preventing it. Liver function tests should be performed before starting a statin and, if there is a clinical indication, during therapy.

LOVASTATIN DRUG INTERACTIONS — New contraindications, drug interactions and dosing recommendations were added to the lovastatin (Mevacor, and others) prescribing information. These are similar to the recent changes in the labeling for simvastatin (Zocor, and others).2

COGNITIVE PROBLEMS — The labeling of all statins will now mention rare post-marketing ... more      

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