Citizen Petition: Statin Drugs Need 100 mg Co-Enzyme Q10

3/4/2005

A Citizen Petition filed with the FDA requests "Statin" drug labeling should be revised to carry a warning that the drugs deplete Co-Enzyme Q10 levels and contribute to the risk of myopathy (muscle weakness - heart weakness).

Statins are a group of common prescription drugs to reduce blood cholesterol levels and the risk of developing cardiovascular disease. They include Advicor(r), Altocor(tm), Baycol(r), Crestor(r), Lescol(r), Lescol XL(r), Lipitor(r), Mevacor(r), Pravachol(r), Zocor(r).

Co-Q10 is required by all of our body cells for energy production. Supplemental Co-Q10 can improve energy production and offer a protective antioxidant effect in the heart and other tissues.

The attorneys filing the petition for Julian Whitaker, MD, state that providing the information on CoQ10 depletion is necessary "so that the consumer can know and the physician can know to take steps before the muscle weakness, to prevent it." The proposed warning claims "All patients taking [statins] should therefore be advised to take 100 mg to 200 mg per day of supplemental Co-Q10."

Co-Q10 taken with statin drugs can help minimize the risk of statins contributing to or causing heart dysfunction, liver dysfunction, muscle-heart weakness and congestive heart failure.

The Tan Sheet, Statin Citizen Petition: Coenzyme effects Should Be Included In Label,
December 6, 2004; p3


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