By Duane Graveline, M.D., M.P.H.
Myalgia, defined as muscle pain, is the most common side effect of statin drugs, occurring with a frequency reportedly as high as 20% in some studies.
Any muscle area can be involved, with the time of onset after the start of statin therapy being as short as a few weeks to several years, on a fixed dose. Weakness frequently co-exists. The pain intensity ranges from dull, nagging to excruciating and incapacitating, almost always aggravated by muscle use.
A definite correlation exists between muscle pain and statin dosage. It is worth noting that statins vary in strength with the newer statins being much stronger than earlier drugs in this class.
A substantial percentage of these statin induced myopathies have been enzymatically negative with consistently normal CPK ( creatine phosphokinase ) test results but many of them fail to subside after cessation of the offending statin. There are many thousands of statin drug users carrying the burden of chronic muscle pain who had been completely free of such complaints prior to statin drug use.
This doesn't even consider rhabdomyolysis deaths in particularly sensitive people occurring at a present rate of just over 30 deaths yearly. Rhabdomyolysis is the dreaded end stage process of muscle breakdown and subsequent kidney blockage and, in the most extreme cases, kidney failure.
The key to myopathy and rhabdomyopathy in terms of mechanism is ubiquinone, arguably the most important essential nutrient. Ubiquinone is more commonly known as Coenzyme Q10, or CoQ10.
CoQ10 depends for its bio-availability upon the same mevalonate pathway of cholesterol biosynthesis targeted by the statin drugs and therefore, is now collaterally damaged in the present war on cholesterol. CoQ10 levels plummet following initiation of statin therapy.
Normal CoQ10 synthesis decreases progressively in humans above age 21 and the average CoQ10 content of the western diet is less than 5 mg/day.
Nearly 60 million people will be taking statins this year in the United States alone. Most of these people will be over 50 years of age. Few of them will be on supplemental CoQ10. Simple logic dictates that the statin drug impact on CoQ10 availability will be profound.
Ubiquinone in its slightly altered form, known as ubiquinol, is found in all cellular membranes where it has a vital function in maintaining membrane integrity. Myopathy and rhabdomyolysis represent breakdown of weakened muscle cell walls due to lack of sufficient ubiquinol for muscle cell wall integrity. This same mechanism also is responsible for nerve cell breakdown and neuropathies.
The subject of special genetic predisposition to statin damage has added considerably to the concern about statin adverse reactions. It has been reported that some 19-24 percent of the population of the United States carries the so-called statin damage SLCO1B1 gene, giving an unusual variation of the transport protein which it codes, so that tissue levels of statins become far higher than intended.
Since statin effects are based upon tissue levels, this means nearly a quarter of the entire U.S. population is predisposed to have a level of statin toxicity.
Muscle Rupture and Statins
On April 13th, 2016, the British Journal of Clinical Pharmacology reported on a number of muscle rupture cases associated with the use of statins. Fifteen cases from the Netherlands pharmacovigilance center were combined with 165 muscle rupture cases from the EudraVigilance database.
I suspect muscle rupture is grossly under-reported if one considers the possibility of small muscle fiber tears masking as myalgia which is one of most common statin associated muscle adverse reactions.
As of the end of the fourth quarter of 2014, 18,416 reports of myalgia had been received by the U.S. Food and Drug Administration’s (FDA) Medwatch with an additional 9,754 reports of muscle spasm, 2,668 reports of musculoskeletal stiffness, 1,956 reports of muscle disorder and 537 of muscle cramping all of which in theory could be associated with underlying tears of muscle fibers.
In the final analysis, the total number of muscle tear reports from the start of statin use through the year 2014, just from Medwatch data, may be in the thousands and only a small percentage of adverse events even get reported to Medwatch.
The following are a few of the reports I have received from readers of my books and website relevant to the subject of muscle pain and statin drugs:
1) I am experiencing many of the side effects listed for Lipitor. I have been taking it for quite some time but the worse symptoms are fairly recent. I have finally been told I have fibromyalgia, which has similar symptoms and problems. Since I read about the fact that Lipitor can be causing muscle problems even when you have a normal CPK, I just yesterday stopped taking it to see if it helps. I have muscle and joint pain, cognitive problems, lack of attention, restless leg syndrome, irritable bowel syndrome, problems walking because my hips begin to hurt so badly and extreme fatigue.
2) I am 45. When I was in my early 30's my blood level for cholesterol was measured at over 700. It was so high that they had to dilute my blood to get a measurement because at the time the readings they were using only went to 400. My trig levels were ~2000 (if memory serves me correctly).
I was put on Mevacor at a fairly high dose and my levels only came down to mid-300. They increased my dosage to the maximum and it came down to the high 200's (280'ish). Soon after taking this level my muscles petered out and my doc was puzzled. This was very early on in the history of Statins and I was one of the first patients that my doc had that was taking Mevacor at the higher dose.
He did some research and had me back off. I was not happy with statins and wanted another, more natural treatment so I opted to take niacin at 3 grams a day. My blood profile looked great for 10 years - 160 totals with a 67 HDL; life was good. About 12 months ago things started going south. My levels started to edge back up. I lost my energy and doing simple tasks gave me very sore muscles. I would wake up in the morning stiff and there were some days were I would not want to even move.
The fatigue became so great that I would have a hard time staying awake while driving the 11 miles to work. On the worst days my entire body would be so sore it reminded me of the day after my first day of skiing for the season - but for no reason! My CPK levels have been measure at 313 - high but not alarmingly so. However my (new) doc has told me to taper off the niacin to 2 grams / day until the CPK levels come back down; he does not care about my cholesterol levels at this point.
I have been doing research on the web and have found a lot of info indicating that CoQ10 levels could be the real problem. I have taken 200mg for two days and I already am starting to feel better. I am still looking for answers but I feel that I am at last on the correct path.
3) Hello Doctor, I just found your web site and am eager to get the new book. I have been taking Lipitor for about a year.
Just this week, in preparation for a colonoscopy, the Dr. noticed my liver seemed to be very hard and swollen and scheduled CT Scans of abdomen and pelvic area. I don't have the results yet, but am very concerned that my liver has been damaged.
Other side effects including memory loss and muscle pain have been very high, but I had no idea these were side effects of the Lipitor. My doctor prescribed it and never scheduled any follow up blood tests, liver tests, etc. and I did not do the due diligence that I apparently should have.
4) I am a woman, now 64 years old. I was put on Mevacor after a heart attack in November, 2001. At the time my cholesterol level was about 185.
After about two years, I read of the possibility of memory loss associated with this medicine. I had been increasingly worried as I was finding that I was forgetting customers' orders, which was very surprising, as I had always had an excellent memory.
I discontinued the Mevacor in February of 2004, and in about two weeks noticed that not only was my mind more clear but severe pain and mobility loss that I had been having in my arms was much improved; a hand tremor that had recently become apparent disappeared completely, and a cataract that had become much worse over those two years was improved about to its previous level.
I asked my ophthalmologist about it, and he said that he had had other cases of cataracts worsening with statin drugs.
Now a year later, I have regained most of the range of motion in my arms and rarely have the muscle pain. At last check my cholesterol level was 235, higher than when the whole thing started.
5) I had been on Vytorin less than a week when I began having muscle pains. Sometimes it felt like someone was sticking a needle or a knife in my legs.
The pain started with my calves and then I noticed I started getting the pain in my thighs. Sometimes the pain was so great I would clutch my leg.
My doctor had me reduce my pill taking from one per day to one every other day, but that did not stop the side effects. I told my doctor I was switching to Policosanol with CQ enzyme. (I took some Policosanol for several days after stopping the Vytorin but it wasn't until I took the Policosanol including the CQ enzyme that the pain in my legs started going away.)
I think the CQ enzyme had some positive effect. I go in for a blood test in a week, and I am hoping that the policosanol supplement I am taking from a vitamin store plus better diet and more exercise will prevent me from having to ever consider taking Statins again.
6) I am a physician, M.D. who has personal experience of several untoward effects of the statin drugs.
First is that of my wife who experienced a severe case of polymyalgia rheumatica as a consequence of taking Pravachol. Second is my own case of an episode of cardiac arrhythmia lasting a month, and unquestionably related to Lipitor.
I also have a feeling that many other episodes of an untoward nature are occurring and not being reported.
I particularly suspect in light of my own experience with Lipitor that there are many other arrythmias occurring such as sudden episodes of atrial fibrillation occurring while taking or sometimes just starting on statin drugs.
I proposed a study that would check all arrythmias against the co-taking of some statin drug, and I believe the investigators would be surprised at the correlation. It's never been done--isn't it time to do so?
I also have been aware of more than a few of personally knowledgeable instances of definite muscle cramps and / or muscle weakness as a consequence of statin drugs.
7) My experience with Statins was almost a fatal one. Three years ago, during a routine colonoscopy, I developed "rhabdomyolysis ". I was not expected to live but made it thru this awful experience. Of course, the doctors never really attributed it to the Lipitor I had been on, but I am convinced it was the culprit.
8) I took Vytorin for two months and stopped one week ago because of joint and muscle pain out of the ordinary. I am a 58-year old female who had an LDL of 211 and after taking Vytorin feel now about 87.
This is good on the side of cholesterol, but too bad for the pain and stiffness left. In fact, according to my doctor, I now have rheumatism. I never had that before.
My diet is very healthy (lots of fruits and vegetable, nuts, yogurt). I also bought Sytropin (HGH) which gave me much strength and zest; however, I wonder which one (Vytorin or Sytropin) has caused me so much discomfort.
9) I suffered a heart attack at age 40 and was prescribed a battery of drugs including Lipitor. It has been 2 years now and I am having weakness, mystery angina pain brought on by nothing, sore muscles and memory / confusion issues.
I have taken myself off the Lipitor and am wondering if these side effects will go away or are they permanent. We'll see what happens. Good luck with your book and thank you for writing it.
10) I was placed on Zocor for high cholesterol (300), and after 2 years I was having great difficulty walking upstairs, painful when sitting, getting up, moving about. I was tired all the time, felt lousy, no energy.
Since I am healthy other than this high cholesterol problem I could not understand what was wrong. Finally I found a medical doctor who also practices "eastern medicine" who spotted the problem right away.
He took me off of this medication from (hell), giving me natural supplements, and I no longer had any problems and my cholesterol dropped down to below 200. Why doctors prescribe the medications that are known to harm people is a mystery to me. Thank you for at least researching this and writing this book.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor
Updated April 2016