CoQ10 is one ingredient that has the support of two Citizens Petitions submitted to the Food and Drug Administration. On May 23, 2002, Julian M. Whitaker, MD, filed the two petitions, which called for a labeling change to all HMG CoA reductase inhibitor drugs (the so-called statin drugs), and to issue a Medication Guide, warning consumers of the need to take CoQ10 whenever they take a statin drug, as follows:
Warning: HMG CoA reductase inhibitors block the endogenous biosynthesis of an essential cofactor, coenzyme Q10, required for energy production. A deficiency of coenzyme Q10 is associated with impairment of myocardial function, with liver dysfunction and with myopathies (including cardiomyopathy and congestive heart failure). All patients taking HMG CoA reductase inhibitors should therefore be advised to take 100 to 200 mg per day of supplemental coenzyme Q10.
This information was further supported by a study, funded by Pfizer, concluding that even brief exposure to atorvastatin causes a marked decrease in blood CoQ10 concentration.
Widespread inhibition of CoQ10 synthesis could explain the most commonly reported adverse effects of statins, especially exercise intolerance, myalgia, and myoglobinuria. The study indicated CoQ10 depletion occurs within 14 days of commencement of statin therapy. For this reason, many physicians recommend CoQ10 after report of statin side effects by their patients.
And no, FDA never commented on the citizens petitions. Interestingly, this warning has become part of the statin monograph in Canada.