New simvastatin precaution
December 7, 2011
THE Therapeutic Goods
Administration is warning health
professionals about a series of new
contraindications and precautions
for the use of simvastatin.
Simvastatin is used to control
elevated cholesterol or
hypercholesterolemia after diet,
exercise and weight loss efforts
have failed, but has recently been
found in high doses, and in those
taking certain other medicines, to
increase the risk of myopathy
(muscle weakness) and, more
rarely, rhabdomyolysis (the
breakdown of muscle fibres
resulting in the release of muscle
fibre contents into the bloodstream).
As a result, the TGA is advising
health professionals to limit the
prescribing of high dose
simvastatin to 80mg/day.
In addition, concomitant
administration of simvastatin with
the following medicines is now
contraindicated: gemfibrozil,
cyclosporine and danazol, as well
as potent CYP3A4 inhibitors,
including: itraconazole,
ketoconazole, posaconazole, HIV
protease inhibitors, erythromycin,
clarithromycin, telithromycin and
nefazodone.
The TGA has also set in place
precautions (such as lower
recommended simvastatin doses)
for patients taking: moderate
inhibitors of CYP3A4; amiodarone;
the calcium channel blockers:
verapamil, diltiazem and
amlodipine; fibrates other than
gemfibrozil; niacin (greater than
1g/day) and colchicine.
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