FDA reverses simvastatin ‘error’

The advice to limit the dose was “made in error” according to communication posted on the US Food and Drug Administration’s website.

“In June 2011, FDA previously recommended that the dose limitation for simvastatin [when taken with amiodarone] be decreased from 20 mg to 10 mg,” it said.

“However, the simvastatin dose limitation when taken with amiodarone …was made in error.

“Therefore FDA has determined that the simvastatin dose limitation, when taken with amiodarone, should be restored to 20 mg.