Studies using several animal models have confirmed no carcinogenic effects and no signs of toxicity at doses as high as 500 mg/kg. This dose is hundreds of times greater than the maximal recommended therapeutic dose (20 mg/day), thereby indicating an excellent safety profile.
A pharmacovigilance study of 2252 subjects aged 60 or more years with coronary, cerebrovascular, and peripheral artery disease and treated with policosanol (5, 10 or 20 mg/day) at seven major medical centres found that long-term tolerability of policosanol in elderly patients at high vascular risk was very good.
Additive effects are likely — caution is advised.
Considering the mode of action of policosanol, it is likely to increase the cholesterol-lowering effects of statin drugs. However, a theoretical concern exists as to whether concurrent use will also increase the likelihood of adverse effects.
Current evidence suggests that there is no interaction between policosanol and warfarin. One clinical study confirmed that the addition of policosanol to warfarin therapy does not enhance the prolongation of the bleeding time induced by warfarin alone. Caution with doses > 10 mg/day.
Contraindications and Precautions
Suspend use of high doses 1 week before major surgery.
Safety has been investigated in animal tests with no evidence of teratogenicity or any other embryonal toxicity.