Cholesterol-Lowering Statin Drugs and the Dietary Supplement Coenzyme Q10

On March 4, 2005, the Food and Drug Administration (FDA) denied two citizen’s petitions to require that the professional product labeling, or package inserts, for the cholesterol-lowering “statin” drugs recommend that the dietary supplement coenzyme Q10 be added to statin therapy to reduce the risk of muscle damage, heart damage and congestive heart failure. Coenzyme Q10 is also known as CoQ10, ubiquinone, or ubidecarenone. It is manufactured naturally in the bodies of humans and most mammals. While coenzyme Q10 is generally not harmful to people, we have explained in the 2005 edition of Worst Pills, Best Pills and online at www.worstpills.org that there have been no studies indicating that coenzyme Q10 is clinically useful in the treatment or prevention of anything. As we’re about to explain, that holds true regarding claims about coenzyme Q10 in the prevention of statin toxicities.

The cholesterol-lowering statin drugs currently approved for use in the U.S. are atorvastatin (LIPITOR), fluvastatin (LESCOL), lovastatin (MEVACOR), pravastatin (PRAVACHOL), rosuvastatin (CRESTOR), and simvastatin (ZOCOR).

The full text of the FDA’s 21-page denial can be found on the Internet at http://www.fda.gov/ohrms/dockets/dockets/02p0243/02p-0243-pdn0001-vol4.pdf. 

The original petition asking for the statin labeling changes was filed in May 2002 by Julian Whitaker, M.D., who operates a Web site that proclaims “Your Definitive Guide to Complementary and Alternative Health.” The petition stated that : Dr. Whitaker recommends the use of CoQ10 [coenzyme Q10] as a dietary supplement and also licenses the use of his name and likeness in connection with the manufacturing and sale of high quality dietary supplements, including CoQ10.

Dr. Whitaker’s petition can be found on the Internet at http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf

More than 50 references were submitted in support of the two petitions, including laboratory data, position papers, animal studies, and clinical investigations that proposed that statins lead to low blood levels of coenzyme Q10, resulting in toxicity from the statin drugs. The FDA reviewed not only the references submitted, but also surveyed the published literature on coenzyme Q10 independently.

A study appearing in the American Heart Journal in August 2001 raises a doubt about a proposed link between statin treatment and coenzyme Q10 blood levels. This study found that the statins pravachol and atorvastatin did not significantly decrease blood levels of coenzyme Q10. The authors question the need for coenzyme Q10 supplementation.

The petitions asked the FDA to require that the labeling of all approved statins include a boxed warning that, in part, discusses what the petitions refer to as “risks” associated with statin-induced deficiency of coenzyme Q10. These are impairment of heart function, liver dysfunction, and muscle pain. In addition, the petitions request that the FDA declare statin-induced deficiency of coenzyme Q10 a “serious and significant concern,” and order the distribution of Medication Guides for all approved statins.  Medication Guides are FDAapproved drug information written specifically for patients that must be distributed with each new and refill prescription by the pharmacist.

The petitions also state that certain “warnings” about decreased levels of coenzyme Q10 now appear in the professional product labeling of all statin drugs sold in Canada.  This, the petitioners contend, shows that the Canadian government has recognized the existence of “reasonable” evidence of an association of a serious hazard with a drug, which should put the FDA on notice and encourage them to grant the requested warning. 

In fact, Health Canada, the Canadian equivalent of FDA, does not conclude that statin-induced decreases in coenzyme Q10 levels have any clinical significance. For example, the Canadian simvastatin labeling says that “Significant decreases in circulating [CoQ] levels in patients treated with [Zocor] and other statins have been observed.  The clinical significance of a potential long-term statin induced deficiency of [CoQ] has not been established....”  The Canadian lovastatin labeling contains substantially the same statements. The Canadian atorvastatin and rosuvastatin labels are similar to the Canadian simvastatin and lovastatin labeling in this regard, but they also includes the following sentence: “It has been reported that a decrease in myocardial [CoQ] levels could lead to impaired cardiac function in patients with borderline congestive heart failure....” This labeling does not conclude that there is reasonable evidence of an association between statin induced decreases in coenzyme levels and heart function in patients with borderline congestive heart failure. It only states that it has been reported.

The FDA concluded its denial of Dr. Whitaker’s petitions with the following statement:

After a thorough review of the information submitted and currently available, relevant scientific evidence, we conclude that there is no reasonable evidence that statin-induced decreases in CoQ levels are associated with impairment of myocardial function, liver dysfunction or myopathies. Nor can we conclude that there is reasonable evidence that CoQ supplementation with statins is associated with decreased risk, prevention, or mitigation of such adverse events.

Accordingly, the requested boxed warning is not warranted because the scientific data does not support the inclusion of such a warning under the applicable legal standard. The current statin labeling already includes the serious and rare side effects of statin therapy, namely, muscle toxicity and liver dysfunction. We have also determined (based on current, relevant scientific information) that Medication Guides such as those you describe are not warranted.  Nonetheless, we continue to give careful consideration to any relevant information that bears on the safe and effective use of statins.

Dietary supplements, such as coenzyme Q10, are marketed in the U.S. without their manufacturers having to demonstrate to the FDA that they are safe and effective for any use. In addition, dietary supplements are produced in facilities that do not follow FDA good manufacturing practice regulations similar to those that must be followed by producers of prescription and non-prescription drugs.  When a consumer purchases a dietary supplement, the consumer does not know if what is listed on the label is actually in the bottle.   This sad state of affairs is the result of the Dietary Supplement Health and Education Act (DSHEA) passed in 1994. This law opened the door for dietary supplement industry and trampled on a basic American right: the right of a marketplace free from untested products that are promoted with unsubstantiated claims.

What You Can Do

You should not use coenzyme Q10 in an attempt to prevent or treat the adverse reactions associated with the use of the cholesterol lowering statin drugs.