The Public Must Be Warned of Statin Drug Dangers

For years I’ve been voicing my concerns about the dangers of the popular cholesterol-lowering drugs Lipitor, Mevacor, Zocor, Pravachol, Lescol, and Baycol (which was recently taken off the market). These drugs block the enzyme HMG-CoA reductase in the liver, which shuts down the liver’s capacity to manufacture cholesterol, and as a result, cholesterol levels drop.

Statin Drugs Block CoQ10 Production

Yet the liver also manufactures coenzyme Q10 (CoQ10) via the same enzyme pathway. Therefore, these drugs also block CoQ10 production, with disastrous consequences to health.
CoQ10 is absolutely essential. Without it, your cells are unable to produce energy. Early complications of CoQ10 deficiencies are liver damage (marked by increases in liver enzymes) and myopathy (muscle weakness and soreness, which may progress to complete muscle breakdown, or rhabdomyolysis).
Guess what? Liver damage and myopathy are precisely the side effects of the statin drugs!

I’m Petitioning the FDA

In spite of my warnings and those of others who have spoken out about this serious yet undisclosed adverse effect of these drugs, nothing has happened. There has been no class action lawsuit against the pharmaceutical companies, nor have these companies made any effort to educate patients and physicians about the necessity of compensating for inevitable CoQ10 deficiencies.

Therefore, I have asked the FDA to step in. I have filed a Citizen Petition with the FDA to ask that a warning be placed on all statin drugs describing the predictable consequences of statin-induced CoQ10 deficiencies and how to avoid them.

The information I used to support my argument in this petition is old news. It has been public knowledge for more than a decade. Thus there can be no denying that the drug companies know about it too. In fact, one company even has patents on the use of CoQ10 to prevent and treat the complications of these drugs. Yet inexplicably, these patents have never been exercised.

The Drug Companies Ignore the Obvious

The pharmaceutical giant Merck & Co., which brought out the first statin drug, Mevacor, in 1987, received two U.S. patents for the concurrent use of CoQ10 and statin drugs. (One patent actually covers combination products of statins and CoQ10.) The purpose of this new “invention” was to prevent and treat the side effects of liver damage and myopathy brought on by statin drugs’ blockage of CoQ10.

The side effects of the drug described in the patent are essentially the same as those in the Physicians’ Desk Reference drug insert and patient hand-outs for Mevacor with one enormous difference. The patent describes CoQ10’s role in the prevention and treatment of the drug’s side effects. In the patient and physician information, however, there is nary a mention of CoQ10, its drug-induced deficiencies, or its ability to eliminate the serious side effects of the drugs. If deficiencies like these had been addressed by statin manufacturers, I believe we would not be enmeshed in our current health crisis.

An Epidemic of Heart Failure

We are in the midst of an epidemic of congestive heart failure, with 400,000 new cases being diagnosed every year. This condition results in an inability of the heart to effectively pump blood. Fluid builds up in the extremities and lungs, breathing becomes difficult, and patients are plagued with weakness and fatigue. Half of the 4.8 million Americans who currently have congestive heart failure will die within five years.
The incidence of congestive heart failure has doubled over the last 12 years, and it has health experts scratching their heads. Why these “experts” aren’t making the connection with statin drugs is beyond me. A primary cause of congestive heart failure is cardiomyopathy, or damage to the heart muscle. And a primary cause of cardiomyopathy is CoQ10 deficiency, which statin drugs are known to cause. The “unexplained” increase in heart failure coincides precisely with the accelerated use of statin drugs over the past decade.

Deaths Could Have Been Prevented

Congestive heart failure isn’t the only problem caused by these drugs. As you may recall, one of the statin drugs, Baycol, was voluntarily taken off the market last year after 31 deaths were attributed to it. (Another 81 deaths were later confirmed.)

Most of these deaths were caused by rhabdomyolysis, significant deterioration of muscle tissue, resulting in the buildup of toxins that can lead to kidney failure and death. Rhabdomyolysis is an end stage of myopathy, and myopathy, as you know, is a complication of CoQ10 deficiency. In fact, rhabdomyolysis is listed alongside myopathy as a side effect of all statin drugs.

If the drug companies had educated patients and physicians about the importance of taking CoQ10 supplements along with statin drugs, the people who died from the adverse effects of Baycol might well be alive today. If the millions of Americans suffering from statin drug-induced muscle pain and weakness or liver damage had been instructed to also take CoQ10, they would probably be free of these debilitating side effects. And if the drug companies had acted responsibly in educating the public, it is quite possible that our current epidemic of congestive heart failure would not exist.

The Antidote for Statin Toxicity

There is an obvious antidote for the CoQ10 deficiencies and associated problems caused by these drugs: supplementation with CoQ10. Statin-induced CoQ10 deficiency can be completely reversed by supplemental CoQ10!

This is the warning label I’m petitioning the FDA to require on all statin drugs:

Warning: HMG-CoA reductase inhibitors block the endogenous biosynthesis of an essential co-factor, 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.

What You Can Do

If you are taking a statin drug, by all means protect yourself by taking 100 to 200 mg of CoQ10 daily (consider getting a blood test to determine your CoQ10 level and increasing that dose, if indicated). And if any of your friends or family members are taking a statin, please tell them about the need to take supplemental CoQ10.

I further advise you to check out safer, equally effective ways to lower your cholesterol level and reduce your risk of heart disease.

Modified from Health & Healing, July 2002, with permission from Phillips Health, LLC. © copyright 2002, Phillips Publishing, Inc. Photocopying, reproduction, or quotation strictly prohibited without written permission from the publisher. To subscribe to Health & Healing, call (800) 539-8219.