FDA WARNING - SIMVASTATIN 80mg (Zocor; or in combination products: Vytorin, Simcor)

The FDA has notified healthcare professionals that it is recommending limiting the use of the highest approved dose of Zocor 80 mg because of increased risk of myopathy and rhabdomyolysis.

Patients taking Zocor 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.

Zocor 80 mg should NOT be started in new patients, including patients already taking lower doses of the drug.

Zocor 80mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).

Pharmacists will be contacting physicians for any increase in Zocor dose to 80mg, and for any patients placed on the 80mg dose on admit who weren't on this dose prior to admit.

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