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FDA reconsiders dose limitation of simvastatin
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The FDA has revised its previous decision and restored the dose limitation of simvastatin to 20 mg in patients who are also taking amiodarone.
In June, the agency ruled that the dose limitation of simvastatin (Zocor, Merck) can be lowered from 20 mg to 10 mg when coadministered with amiodarone. The FDA also restricted the use of the highest approved dose — 80 mg — to decrease risk for myopathy, leaving 40 mg as the maximum safe dose, according to a press release. Further, the agency proportionally lowered all maximum safe doses of simvastatin when taken with certain interacting drugs, such as those that can raise simvastatin blood levels.
However, the FDA erred in its decision to lower simvastatin’s dose limitation from 20 mg to 10 mg for patients who are also taking amiodarone, as no pharmacokinetic or clinical trial data support the dose reduction. Therefore, the agency determined that the simvastatin dose limitation be restored to 20 mg.
All labels for simvastatin have been revised to reflect the change.
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