The headlines have taken our breath away:

“Statin Side-Effects Questioned”

“Statins do NOT have major side effects, claims study”

“Statins Have Virtually No Side-Effects, Study Finds”

“Side Effects Reported in Those Taking Statins Are Not Actually Attributable to the Drugs”

“Statins have ‘fewer side effects than placebo’, suggests UK study”

These headlines all resulted from an article published in The European Journal of Preventive Cardiology (March, 2014).

The authors concluded:

“At the doses tested in these 83,880 patients, only a small minority of symptoms reported on statins are genuinely due to the statins: almost all reported symptoms occurred just as frequently when patients were administered placebo. New-onset diabetes mellitus was the only potentially or actually symptomatic side effect whose rate was significantly higher on statins than placebo; nevertheless, only 1 in 5 of these new cases were actually caused by statins.”

So, what are we to make of this? Clearly, the media has announced to the world that statin-type drugs do not cause side effects. Reporters have gone so far as to suggest that sugar pills (placebos) cause more complications than statins. In other words, if you think your atorvastatin (Lipitor), lovastatin (Mevacor), rosuvastatin (Crestor) or simvastatin (Zocor) could be responsible for your muscle pain, weakness, mental confusion, nerve discomfort or cataracts, you are wrong. Such symptoms are all in your head. The only possible drug-induced complication of statins (according to these authors) is diabetes.

Pretty much ignored by the press has been a section in this article titled: “Comparison with real-live clinical experience.” The authors admit that:

“Many real-world patients report muscle-related symptoms with statins. This contrasts with the low placebo subtracted rate in blinded trials shown in this meta-analysis. Several explanations are possible. First, commercial sponsors of clinical trials may not be motivated to search exhaustively for potential side effects…Second, many trials do not state clearly how and how often adverse effects were assessed…”

This is a really important caveat. Other researchers have noted that “myopathy” (muscle pain, cramps and weakness) has been defined in all sorts of different ways in statin clinical trials. In some cases, it was restricted to enzyme elevation. In other words, a patient might suffer pain, but if their enzyme levels were within “reasonable” limits, this might not be counted as actual myopathy.

An article in BMJ (October 22, 2013) noted that “the prevalence of muscle pain in statin users is 50% greater than in non-users. In absolute terms, this increase in muscle pain is 100 times greater than that reported in clinical trials…”

Put another way, the gold-standard randomized controlled trials that were analyzed in the article making headlines this week may not have collected accurate data about muscle pain and weakness. The authors even admit that such studies may have underestimated the true incidence of new cases of diabetes attributable to statins (1 in 5 patients). As they point out, “This means that, of all new diabetes diagnoses on statins, 20% were directly pharmacologically attributable to statins…[though] new diagnosis of diabetes was only documented in three of the 29 trials.” Read between the lines and you will immediately realize that this serious complication of statin therapy was completely missed by the vast majority of clinical trials.

This has been pretty much ignored or glossed over by the media. One of the authors, Ben Goldacre, points out some of the caveats that should be taken into account on his blog.

People’s Pharmacy Analysis:

Randomized clinical trials, especially those designed to obtain FDA approval, are not set up for detecting adverse drug reactions and they don’t do it very well. They are really designed to demonstrate drug effectiveness rather than risk. A little-realized fact about such trials is that the way in which side effect information is collected may actually affect the study.

This was revealed in a landmark report by Jerry Avorn, MD, and his colleagues in a fascinating study titled: “Differences in Adverse Effect Reporting in Placebo Groups in SSRI and Tricyclic Antidepressant Trials: A Systematic Review and Meta-Analysis” (Drug Safety, Nov. 2009). Dr. Avorn and his co-authors concluded that:

“Conclusion: Adverse effect profiles reported in clinical trials are strongly influenced by expectations from investigators and patients. This difference cannot be attributed to ascertainment methods. Adverse effect patterns of the drug group are closely related to adverse effects of the placebo group. These results question the validity of the assumption that adverse effects in placebo groups reflect the ‘drug-unspecific effects’.”

In other words, the side effects reported in the placebo groups were seemingly affected by the kind of antidepressant being studied. If the drug itself caused dizziness, constipation and dry mouth in a high proportion of patients, the people getting the placebo in that trial magically had a high incidence of dizziness, constipation and dry mouth.

The conclusion doctors might make would be that since the symptoms were similar for both the placebo group and the drug group, there is no difference between them. But this is a trap. By comparing the side effects experienced only by people taking placebos in antidepressant trials the truth was revealed. You would imagine that people getting inactive placebos for the same condition (depression) would have similar side effects. But Dr. Avorn’s study shows that the placebo side effects vary enormously depending upon the type of antidepressant being studied.

We suspect that this may also be relevant for the current statin side effect analysis. If researchers influence side effect reports by the way they ask the questions or collect the data, it may be more difficult to determine the true incidence of adverse reactions to statins. We find it difficult to imagine that statins actually have no side effects. What do you think?

Here are some complications listed in the official prescribing information:

STATIN SIDE EFFECTS:

Headache
Muscle aches, muscle cramps, muscle pain, spasms:
(anywhere in the body, including legs, shoulders, back, arms or neck)
Fatigue, weakness
Arthritis, joint pain, joint stiffness
Abdominal pain, digestive upset, nausea, diarrhea, flatulence
Blood sugar elevation, diabetes
Sore throat, flu symptoms, sinusitis
Dizziness
Itching, rash, hives
Liver damage, liver failure, kidney damage
Insomnia, sleeping difficulties, nightmares
Forgetfulness, memory problems, amnesia, confusion, cognitive dysfunction
Peripheral neuropathy, nerve tingling, nerve burning
Pancreatitis
Cataracts
Sexual problems, erectile dysfunction, low libido

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  1. TTM
    Ma.
    Reply

    Sept 2014
    I started taking a statin several years ago (at least 4) for cholesterol. I am overweight and often have muscle and joint pain. But i work full time and im on my feet all day. Cholesterol consistently stayed high.

    Last year after a type 2 diabetes Dx. I changed my way of eating and my (second blood work 6 months after new way of eating started) blood work showed my cholesterol , triglycerides and A1c in normal range along with some weight loss. My. Dr. did not want me off the statin though. For my health.

    My muscle and joint pain, increasingly got worse. I started having muscle spasms and cramps like a Charlie horse in my upper back/shoulder blade area and arm along with neck, elbow, knee and smaller joints pain, fatigue and anxiety. I had EMGs and EKGs, done and it was determined I have pinched nerves, and herniated discs. Thankfully no heart problems. I started PT. And it helped a bit but not completely. PT ended and life went on. Then my face went numb and a brain MRI was ordered. They found white spots on the brain MRI that could be the start of MS but could also be a result of previously having Diabetes, high cholesterol and headaches. I have a follow up with the neurologist in 3 months. I need to chart my symptoms.

    After reading posts online I stopped taking the statin Aug. 14 I made an appointment and asked my primary Dr if I could stay off the statin? the answer was yes. It has been a week off and I have not had one severe muscle spasm. I have a lot of muscle pain, weakness in my legs, back, arm, severe hip pain and a continued feeling of buzzing in my abdomen and thighs… I have muscle twitching and shaking still in my back and arm sometimes also. I am feeling a lot of anxiety and fatigue. I was placed on a anxiety med and also given something to help me sleep.
    I have to wonder out loud if the statin has played a roll in my muscle cramping and pain. Is this a symptom others have had after taking a statin?

    If after taking the anxiety med for 4 weeks I am still feeling “MS” symptoms my primary will send me for a second opinion with a different neurologist for further testing sooner in Boston.

    I started taking CoQ10 also. What type of Dr. Would diagnose and or treat issues related to statin muscle damage?

  2. MM
    Reply

    My husband was on fenofibrate and Niaspan. Over time he began falling down frequently, became borderline confused, had slurred speech, and had loss of hearing in both ears. I talked to his cardiologist, took him to neurologists, his primary MD and a eye, ear guy. No one found anything wrong with him. He was reaching the point where even with a walker he was falling. He was going downhill so quickly, I was convinced he was dying and no one could tell me why. I did not feel like anyone was listening to us. We had the impression that the physicians thought we were idiots. He takes a lot of different meds for his cardiac issues and the only drugs I felt comfortable taking him off of myself were the cholesterol lowering drugs. The cardiologist was not happy. But, after a couple of weeks to a month, I noticed he wasn’t falling anymore, his mind was much clearer and his speech was no longer slurred. His cholesterol has remained within normal ranges. I do recommend that prior to taking the step to stop meds you should speak to your physician.

  3. paulbyr
    Reply

    I have been trying to make sense of all this “data” without any conclusion. I started taking Zocor, 20 MG, in 1994, then was switched to 40 MG about a year later. I had a mild TIA (stroke) in 2002 and started walking my dog 45 minutes (instead of 20) every day and also lost a lot of weight – down from 205 to 175, but my cholesterol stayed about the same – total was about 115.
    No more strokes, never any heart incidents, I have had cardiologist administered stress testing about every 5 years. Always passed fine.
    Since I’m now 77 and my cholesterol is good (total about 100) with daily 20 MG Zocor + 1000 mg niacin (switched in 2012), my main complaint is neuropathy (numbness, needle prick feeling) in both feet, more in the left foot. I also have memory problems, but, as I said, I am 77. I now am down to 160 lbs. I wondered why I don’t have leg cramps, can it be because I walk every day instead of maybe, jog.

  4. kb
    Reply

    my dr went to a site in front of me and said my side effects were not on there, now they are, he did a drug screen because he didn’t believe the crazy side effects I had, years later they came out, 2 drug companies own lawyers later told me, every thing I told them was true, one said “no one over 50 should be on cholesterol meds” and some other suff. I wrote a book of horrors so my family would have a record of my mental nightmares, of the troubles and money, I lost jobs and money over 100,000. Could not work I was so sick…every one I know who took statins, had the same troubles depending on mg. I now suffer 8yrs off, with muscle weakness so bad it’s unreal, the book don’t even start with all the troubles I suffered. kb

  5. RW
    Reply

    I have been taking Simvastatin since, 2008. Since then, I have been experiencing unbelievable muscle pain/cramps in my leg and, feet. After reading other user comments regarding this drug on webmd as well as on here, I am convinced it is the Simvastatin that’s causing the muscle pain. So, I’ve decided to stop taking it because, the muscle pain I’ve experienced is just too much to bare.

  6. PAH
    Reply

    After six weeks on Crestor, I would walk up a flight of stair in so much pain in my heart that I thought I was having a heart attack. I was so out of breath that I couldn’t talk to my customers. I credit Crestor with damaging my pulmonary artery in my heart and causing Pulmonary Hypertension (PAH).

  7. John W.
    Reply

    I have taken two different statins in the last six years. I suffered cramps in areas of muscles that I never would have expected. In my arms, my neck. Even my facial muscles. I stopped taking the first statin on my own. After about ten days the cramps stopped. My Dr. prescribed a different statin. Same result. Cramps again. Stopped on my own two weeks ago. I am again cramp free. Another Dr. prescribed Crestor. I do not intend to take this statin. Can’t understand this love affair doctors have with statins. I now love MY life without statins.

  8. Mel
    Reply

    My husband took Lipitor 10 mg/day for 4 yrs for a mildly elevated cholesterol level. He was a daily runner, a marathoner and worked out at the gym 5 x/week. He has profound Parkinson’s disease we both attribute to Lipitor.
    He possesses mutations in 2 genes responsible for the movement of statins into the liver for phase II detoxification. These genes are not rare, one occurring in 24% of the Caucasian population. Plasma statin levels in these individuals with the risk alleles who take statins were discovered to be toxic levels. The lucky ones developed severe myopathy and stopped the statin. My husband developed a progressive neuro degenerative disease.

  9. Don
    Reply

    After reading all of the above comments, and especially the last one from Chris, it makes me wonder how many millions of dollars we spend annually just chasing down the cause of these horrible side effects. Yet, the answer is right in front of us the entire time.
    Chris, you do not state why you take Crestor, but I encourage you to find a different doctor to review this. After many years of taking various statins (all with a number of side effects) simply due to her “high” total cholesterol number, a doctor finally ran the risk calculation number for my wife. She wasn’t even close to the threshold for statins. Off them now, and I doubt she would ever go back on them.

  10. Chris H.
    Reply

    It is March 20th, 2014. I have been battling Vertigo, dizziness, withdrawn, confusion, lack of cognitive ability, depression, muscle aches and outright want to die attitude for nearly 3 months. I have been to a family DR., therapists, neurologist, ENT specialists. Have had CT’s MRI’s, and you name it have probably had it. Had an episodic event that looked like the onset of a stroke which the MRI indicated no brain damage but possibly a TIA.
    Neurologist at the Cleveland Clinic disputed this on my follow up and told me possibly High Blood pressure maybe causing all of this. Self monitoring for over a month indicated minor elevations after having been on Crestor for many months. But ever since I have been on Crestor the side effects have been as mentioned above. Especially overall lack of well being. I quite simply FEEL TERRIBLE, no desire to do anything, dizzy all the time, withdrawn, confused, cognitive function lowered, no motivation, achy muscles and high level of mood swings.
    I AM CONVINCED CRESTOR IS DOING THIS. MY DR IS NOT. I may need to find a new Doctor. All my reading indicates Lose Weight, eat natural, cut out all the synthetic drugs and get off the Grid. Imagine that!! Guess it is time to at least try some of this.

  11. emh
    Reply

    Never, Never, will I take a statin. Even the most smallest, tiniest milligram of a pill makes me sick!
    The muscles will never be the same after I took that first batch. Don’t believe these “scientists”, it’s bull___!
    I am 66 years and I want to be older and healthier and I know I can do it without statins!!
    By the way, love all the healthful info you give us. Thank you thank you!!

  12. Amy
    Reply

    OMG I can’t believe I just found this. I was just discussing this with a friend earlier today without even knowing this article existed.
    I have a suspicion that after taking Lovastatin for 5 yrs that this drug is backfiring on me and hurting me instead of helping. I have been experiencing pins and needles feeling in my feet and legs for at least a year or so that I can remember. I mentioned it to my previous neurologist believing it was a nerve issue not a drug issue. Nothing was done and it was kind of dismissed. 6mo ago I suddenly experienced SEVERE pain and tingling in both my hands AND feet. I was in so much pain it would wake me. Another doctor tested me and said I have neuropathy or the beginnings of it. He wants me to have a blood test and see him in a month. In the meantime I was doing reading on Neuropathy and an interesting this is that it said Statin drugs can cause that.
    I need to bring up this issue with the doctor and hope he will agree with me or at least be willing to try to take me off the drug for awhile. What can it hurt? I’d be willing to try a non statin drug.
    Are there any non statin drugs?

  13. DMS
    Reply

    Joe and Terry,
    Thank you so much for all the information you provide to help people without causing potential harm to our health.
    In 2009 I started Lipitor and had no immediate side effects. In 2010, I moved to another state. I had started having difficulty performing my job as a TSA Officer. When I had to hand wand or pat down a passenger, I had trouble standing back up due to lack of strength in my legs I had no idea what was causing this.
    Around the same time, I had a neck injury and was being treated by a Chiropractor. Since they correct the whole spinal area, he was having less success than he expected, he asked what medications I was on. As soon as I said Lipitor, he told me I needed to add CoQ10. I researched this and the side effects of statins.
    I started the CoQ10 and stopped Lipitor. My muscle strength came back completely with in 2-3 months. I believe I would have been in a wheel chair eventually if I hadn’t stopped the statin.
    And now I know more about the importance of Cholesterol thanks to you and some others who study effects on the brain.

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