FDA: Statin Zocor causes muscle injury
Editor's note: Readers should be aware that if lowering cholesterol is a way to cut risk of heart disease, statins like Zocor is not the only medication they can take to lower the cholesterol. Some foods and nutrients may help lower cholesterol in some cases more effectively than statins. To ultimately reduce risk of heart disease regardless of the cholesterol status, one needs to follow a healthy diet. Ask Dr. Dean Ornish for his dietary advice that may save your life.
(Some development: Research suggests vitamin E and C may help lower cholesterol. Stay tuned for details)
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On March 19, the Food and Drug Administration notified health care professionals as well as patients that data from a large clinical trial and other sources indicated that use of Zocor, a statin made by Merck and commonly used to lower cholesterol by consumers to lower cholesterol, raises risk of muscle injury when used in large doses and in some patients on other medications.
The muscle injury risk was found particularly high in patients who took the highest approved dose of 80 milligrams per day of the cholesterol-lowering medication, Zocor which is based on simvastatin, an active ingredient that is also used in other products.
In the Drug Safety Communication titled Ongoing Safety Review of High-dose Zocor (simvastatin and Increased Risk of Muscle Injury, the FDA says the risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor was higher than that in patients taking lower doses of Zocor and possibly other statins.
The muscle injury of concern is also called myopathy. It is actually a side effect with all statin medications, according to the FDA. The common symptoms include muscle pain, tenderness or weakness, elevated level of a muscle enzyme in the blood called creatine kinase. High doses of Zocor lead to high risk of muscle injury. The risk is elevated particularly when Zocor is used together with certain other drugs.
For the safety reason, the FDA suggests patients should not use Zocor if they use itraconazole, ketoconazole, erythromycin, clarithromycin,telithromycin, HIV protease inhibitors, and nefazodone. Patients on diltiazem may use no more than 40 milligrams of Zocor per day. Those on Amiodarone and verapamil may use no more than 20 milligrams of Zocor per day. Those on Gemfibrozil, cyclosporine and danazol may use no more than 10 milligrams of Zocor per day.
The most serious form of muscle injury is rhabdomyolysis which occurs when a protein called myoglobin is released as muscle fibers break down. This protein can damage the kidneys as they filter blood out of the body. Symptoms of this condition include dark or red urine and fatigue in addition to other common muscle injury symptoms. In rare cases, rhabdomyolysis can lead to fatal kidney failure.
The FDA says healthcare professionals should know that rhabdomyolysis is rare, but reported with all statins and they should be aware of the potential risk of muscle injury from the 80 milligrams of Zocor per day.
The drug regulator advises that patients should not stop taking Zocor unless told so by their healthcare professionals. In cases patients experience symptoms of muscle injury including muscle pain, tenderness or weakness, dark red urine or unexplained tiredness, they should contact their healthcare professionals.
The SEARCH trial of 6031 patients who had experienced a heart attack prompted the FDA to issue the warning. The trial results showed that among those who took 80 milligrams a day of Zocor, 0.9 percent experienced muscle injury compared to 0.02 percent among those who took only 20 milligrams of Zocor per day. Eleven patients who used 80 milligrams of Zocor per day developed rhabdomyolysis compared to none among those who used only 20 milligrams.
The risk is not news. In 2008, the FDA alerted the public to an increased risk of rhabdomyolysis in patients using higher than 20 milligrams of simvastatin along with amiodarone.
One ongoing trial called the Heart Protection Study 2 resulted in some interim outcomes suggesting that patients of Chinese descent should not use 80 milligrams of simvastatin with cholesterol modifying doses of niacin-containing products.
Accordingly, in March 2010, the health agency approved a labeling revision for simvastatin. The revised label also recommends that patients receiving cholesterol-modifying products should take no more than 40 milligrams of Zocor per day.
The ongoing trial found 0.43 percent of patients of Chinese descent suffered myopathy compared to 0.03 percent of their counterparts not taking 40 milligrams plus cholesterol modifying products.
Statins are a class of cholesterol-lowering medications, which are controversial because studies have found these drugs are not worth the money or at least not effective as desired in preventing heart disease. In some cases they do more harm than good.
Statins may disappoint some patients. Luckily some modified lifestyle including healthy diet can lower cholesterol, most importantly risk of heart disease. Those who are interested should contact Dr. Dean Ornish, a Harvard educated medical doctor who is a professor at the University of California - San Francisco.
Some doctors say medical research has provided evidence suggesting that cholesterol is not the cause for the risk of heart disease. In addition to muscle injury, taking Zocor and other statins may also raise risk of diabetes, heart failure and eye disorder, as reported early on foodconsumer.org.
In any event, following a healthy diet is the fundamental way to reduce the risk of heart disease. Dr. Ornish uses his diet and lifestyle program based on a modified diet to help patients prevent progression of artery clogging and reverse atherosclerosis. The efficacy is said to be 99 percent, according to Dr. Colin T Campbell, a distinguished Cornell University nutrition professor.
By Jimmy Downs
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Healthy lifestyle including a healthful diet is a viable substitute to zocor. In a healthful diet, overly processed foods need to be eliminated because they contain rich amounts of harmful oxycholesterol (oxysterols) or oxidized cholesterol -- specifically, 7 beta-hydroxycholesterol, 7-ketocholesterol, and 5 beta, 6 beta-epoxycholesterols -- the chemicals found in cholesterol-rich diets and associated with atherosclerosis.
A growing number of scentific papers have clearly shown that dietary oxycholesterol promotes the development of atherogenic oxidized LDLs or LDLs that accelerate atherosclerosis.
Preclinical studies have showed that a diet high in these oxidized cholesterols resulted in a 100% increase in fatty streak lesions (the early stage of atherosclerosis) in the aorta with increased levels of oxycholesterol in the atherosclerotic plaques. Clearly, western diets containing high concentrations of oxidized cholesterol increase the serum levels of oxidized cholesterol-rich LDLs which, in turn, boost the build-up of atherosclerotic plaques.
Nearly half a century ago, researchers showed that cholesterol antibodies may be boosted to immunologically clear LDL, a potentially useful strategy to reduce serum cholesterol levels and dietary-induced aortic atherosclerosis. A number of independent reports over the past decade have correlated high levels of anticholesterol antibodies with a significant reduction of both diet-induced hypercholesterolemia and atherosclerotic lesions.
Humans with peripheral atherosclerosis and cerebrovascular disease reportedly have low levels of circulating cholesterol antibodies.
Recent studies by Origo Biosciences found that naturally-occurring anticholesterol antibodies recongize oxidized cholesterol LDL in the blood. The source of oxidized cholesterol in LDLs originates as cholesterol-rich micelles in the gut through the introduction of processed foods. Hence, gut micelles rich in oxidized cholesterols become an attractive target for anticholesterol antibodies.
Naturally-occurring anti-cholesterol antibodies may play an ‘immuno-housekeeping’ or protective role by facilitating the clearance of oxidized cholesterol-rich particles in both the blood stream and in the gut.
Interestingly, Origo Biosciences found these antibodies in certain dairy products. Certified anticholesterol-active whey and milk as a highly functional ingredient may find some application in a variety of foods, beverages, and supplements to help prevent dietary oxidized cholesterol from being absorbed in the gut.
Origo believes that these dairy-derived antibodies may prevent oxidized cholesterol uptake in the body and serve as a safer alternative to zocor.
Millions of people have genetically high cholesterol #1, #2 NOBODY but a freak that exercises 16 hours a day and eats straw and water can get their cholesterol to the level that has been proven to REVERSE buildup.
So, NO, idiot, exercise and lifestyle changes ARE NOT substitutes for statins.
And the whole big SCARY TITLE of this article is a RARE side affect, not a foregone conclusion. IDIOT.
To me as a drug consumer, this is a great article. I don't care about the grammar. I came here to learn something other than English. I know many people who are technically savvy in the IT industry and medical research do not speak and write English well. But who would care about that so long as these guys can send satellites to their orbits? I say this is a good article because it gives me some information my doctors would not.
Physicians know a lot about drugs and they are trained to write prescriptions. But they, okay most of them, are not trained to give their patients any dietary advice. Medical students are not required to take any nutrition courses in the majority of medical schools. Most physicians suffer deficiency of knowledge in nutrition.
Doctors can say statins are good for their patients. I personally believe that these statins do help some patients. But they are not in a position to say a healthy diet could not beat statins because they don't know much about nutrition and diet.
I dont eat dairy,meat,eggs or fish.My cholesterol was 10 I brought it down to 7.6 with my diet.I know this is still to high.I really do not want to take pills
The truth is that NO woman should ever be given Zocor, Crestor, Lipitor or any other statin drug for elevated cholesterol. There are no statin trials with even the slightest hint of a mortality benefit in women and women should be told so. In other words, statin drugs don’t work for women.
To read more:
http://www.drdach.com/Cholesterol_Women_Dr_Dach.html
Jeffrey Dach MD
Um ... since when did amiodarone contain simvastatin? Or, did you mean to write, "...together with the drug called amiodarone"?
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Editor's response: Thanks. The error has been corrected.
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051756.htm
Are we looking at another tragedy unfolding and yet another embarrassing about face by a compromised regulatory agency. Meanwhile the "lipid hypothesis" itself is being more and more widely questioned after decades of intensive lipid lowering have had no effect on heart disease rates. Perhaps even more astonishingly, when Dr. Uffe Ravnskov, MD PhD reviewed the medical literature he found something quite surprising had been documented there. On average, at least according to Dr. Ravnskov's review of the literature, people with higher cholesterol live longer. You can read on this here http://healthjournalclub.blogspot.com/2009/10/do-people-with-high-cholesterol-live.html if interested.
There is also a write-up about Dr. Duane Graveline, MD and former NASA astronaut's findings concerning statins and the rare but serious side effect of global transient amnesia. http://healthjournalclub.blogspot.com/2009/11/statins-and-global-transient-amnesia.html
Wonder if this new FDA advisory will change prescribing patterns? Or will the Zocor indication just be expanded to healthy people with normal cholesterol?
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