Private MD News

FDA warns against high doses of cholesterol medication

Category: Heart Health and Cholesterol

For many patients who have received unhealthy cholesterol test results, simvastatin - known by its brand name of Zocor - has helped them limit their risk of cardiovascular complications. However, the Food and Drug Administration is now warning patients that the drug may cause serious side effects when taken in high doses.

Agency officials said that evidence is emerging that the medication can cause a condition known as rhabdomyolysis, which is a severe form of muscle injury that has also been tied to an increased risk of kidney damage, kidney failure and in some instances death. This side effect has been observed in patients who are taking doses of over 80 milligrams.

While the FDA warning stopped short of recommending that patients stop taking higher doses of the medication, officials did say that the new information should give medical professionals pause before prescribing it.

"It's important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy," said Eric Coleman, deputy director of FDA's Division of Metabolism and Endocrinology Products.