The cholesterol-lowering statin drugs currently approved for use in the
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
In fact, Health
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
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.