FDA Approves New Labeling for VYTORIN

The Food and Drug Administration (FDA) recently approved new labeling for the cholesterol lowering drug, VYTORIN to include new data from the Study of Heart and Renal Protection (SHARP). The SHARP study showed that VYTORIN effectively lowered cholesterol in patients with severe chronic kidney disease, with fewer major vascular events in patients taking VYTORIN as compared to the placebo.

As it relates to women, this news may not be as rosy. VYTORIN contains simvastatin, which occasionally causes myopathy manifested as muscle pain, tenderness, or weakness with CK levels above 10 times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. Amongst the predisposing factors for myopathy is female gender.

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