FDA Urges Caution in Use of High Dose Of Cholesterol Medication Simvastatin

June 8, 2011, 10:48 PM UTC

The Food and Drug Administration June 8 recommended that health care providers “sharply” curtail the use of the 80 mg strength of the cholesterol-lowering drug simvastatin because of the risk of muscle injury.

FDA said the 80 mg pill, the highest approved dose, only should be taken by patients who have been using it for 12 months or longer without any ill effect. The agency also said there are new contraindications and dose limitations for when simvastatin is taken with certain other medications.

The statin is sold by Merck & Co. under the brand name Zocor and as a single-ingredient ...

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