When lovastatin was first approved by the FDA in 1987 under the brand name Mevacor, it was perceived as a breakthrough in cholesterol reduction. Here was a drug that many believed would prevent heart disease without the unpleasant complications of previous types of cholesterol-lowering drugs. Merck, the maker of Mevacor, ramped up its marketing muscle. Together with the American Heart Association and the government’s National Cholesterol Education Program, Merck was able to convince a lot of doctors and patients that Mevacor was the answer to America’s number one killer.
Over the intervening years there have been lots more statins and drug companies have continued the campaign to convince physicians that such drugs are a safe solution to the plague of high cholesterol. The perception for decades has been that such drugs have huge benefits and few, if any, significant side effects. One, rhabdomyolysis or severe muscle breakdown, is considered extremely rare and not something most people need concern themselves about.
But over the years patients have become aware that there are a substantial number of serious side effects that can have a profound impact on their quality of life. Reluctantly, many health professionals have begun to acknowledge that maybe statins can produce some unexpected complications. The latest problem was just reported in the BMJ (formerly the British Medical Journal) on March 19, 2013.
Canadian researchers tracked over 2 million patients from seven Canadian provinces as well as subjects in the U.S. and England. These were people put on statins between 1997 and 2008. Over 600,000 were receiving what are classed as high dose or high-potency statins.
High Dose or High-Potency Statins Defined:
Atorvastatin (Lipitor): 20 mg or more
Simvastatin (Zocor): 40mg or more
Rosuvastatin (Crestor): 10 mg or more

The Canadian investigators discovered that when people were exposed to these “high-dose” or “high-potency” statins compared to either no statin, niacin, lower doses or lower-potency statins, they experienced an increased risk for kidney injury or failure. The damage was detectable within the first 4 months of treatment and remained elevated for at least two years. To be specific, those on high potency statins (as defined above) were 34% more likely to be hospitalized with acute kidney injury compared to the control patients.
Many health professionals will pooh-pooh this kind of “observational” study. Even though the researchers examined a large number of patients over a long period of time, it is not considered gold-standard research. That would require a randomized, placebo-controlled, double-blind study where some patients get a sugar pill while others get the active drug. They are then followed for a specified length of time. Such RCTs (randomized controlled trials) are perceived as the best kind of research.
One such trial was called JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin). It compared 20 mg of Crestor (rosuvastatin) with placebo and involved 18,000 patients. Look carefully at the data and you will discover that there was indeed a signal. Although not statistically significant, there was a 19% increased risk of kidney failure in the patients taking Crestor. If you looked carefully at creatinine levels (a measure of kidney function) in the Crestor patients, the risk increased to 35%.
Another large epidemiological study published in BMJ of statin users (also involving over 2 million patients) noted an increased risk of kidney failure. In this study the relative risk was greater than 50%.
What are we to make of this new study and prior research? The authors suggest that high-potency statins (as described above) could be depleting the body of Coenzyme Q10, and this might be contributing to the problem. We would encourage patients to discuss lower doses of statins or lower-potency statins (if statins are essential for preventing a second heart attack) with their physicians and talk about the role of Coenzyme Q10 in possibly reducing the risk of kidney damage. We would also encourage patients to be carefully monitored for kidney function regardless of dose.
Other side effects of statins that have come to light over the last two decades include:
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

We have been disheartened to learn that many of these side effects were not discovered during the original drug testing period. Although the FDA puts great faith in randomized controlled trials, many drug complications are not discovered through this process. It is only after years on the market that researchers uncover some of the more common or more serious adverse reactions noted above.
If you would like to learn more about the flaws in our regulatory and medical system, you will find our book, Top Screwups Doctors Make and How to Avoid Them of interest. You may also appreciate our book, Best Choices From The People’s Pharmacy with a wide range of options to deal with things like high cholesterol, hypertension and arthritis. They can all be found in The People’s Pharmacy Store.
And please comment below on your experience with atorvastatin, rosuvastatin (Crestor), simvastin or other statin-type cholesterol-lowerind drugs.

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  1. JBP
    Reply

    Took 20mg Lipitor and then generic for at least 7 years along with CoEnzyme Q10. Cholesterol numbers very good and never had any problems. In last year, however, I began having muscle cramps and pain and, most disturbing, memory loss and impaired cognitive function. At my lowest point I was sitting at my desk and realized I could not think through the steps needed to complete a simple task.
    Fortunately, I read article about new issues with statins in NYT and, with approval of my doctor, stopped taking drug. Within 2 weeks my symptoms were gone. Unfortunately, my cholesterol numbers are back up (family history) despite careful attention to diet and increased exercise. Am searching for new options. Am I better off resuming statins but at a lower dosage? What would be benefit of a non-statin like Zetia or Lipofen?

  2. Marie
    Reply

    From package insert Sweden
    I have just read the Swedish package insert for Lipitor (as well as for the copy =atorvastatin). I noticed this (my translation).
    Warnings and Precautions
    Talk to your doctor, pharmacist or nurse before using Lipitor.
    Lipitor can be unsuitable for you in the following situations:
    if you have previously had a stroke with bleeding in the brain, or have small pockets of fluid in the brain from the previous stroke
    if you have kidney problems
    if you have hypothyroidism.
    if you have had repeated or unexplained muscle pain or muscle problems personally or in the family
    if you have a history of muscle problems during treatment with other lipid-lowering drugs (eg other statin or fibrate)
    If you regularly drink large amounts of alcohol
    if you have or have ever had liver disease
    if you are over 70 years

  3. RCM
    Reply

    I am wondering if anyone has had a family/friend on a statin or Lipitor specifically, who developed a cerebral hemorrhage (fatal or non-fatal) which presented as a “stroke” and what the medical folks will sometimes call a “hemorrhagic stroke.” I am gathering data. I do not trust the statin drugs but need some hard evidence to present my case. I am a nurse of 30 years, and my gut feeling about these drugs has never been favorable. Now with a family member who took it for 8-10 years and had cerebral hemorrhages – but not a stroke – I am gathering data. I smell a rat and it isn’t in the lab.

  4. MD
    Reply

    I took statins for a few years with no problems until the muscle cramps started. They were extremely painful and as soon as one cramp eased up another would immediately begin in another area. These bouts of cramps could last from 15-40 minutes. Usually this occurred in my legs but not always. I have had my thumb contort in an impossible position during a cramp. My arm muscles sometimes cramped… but usually it was my feet and legs. There were nights I was in so much pain I considered going to the ER. I spoke to my doctor several times. She ran blood tests and no deficiencies showed up. I tried another statin but the cramps continued. Finally, I told my knee specialist suggested I quit the statins as he was certain they were the root of my problem. After a few weeks the cramps lessened although it took almost a year for the cramps to stop. I still occasionally get some, but I can handle these. Whenever I hear someone speak of muscle cramping that won’t go away I always ask if they are on statins.

  5. CMS
    Reply

    I took Crestor for several years. Two summers ago I developed muscle pain. The Dr. stopped the medication and the pain went away in three weeks. He told me he wanted to try a lower dose and have me take CoQ 10 with it. I was able to tolerate this until the following March when I developed neck pain, inability to turn my head, and inability to lean over and pick up something from the floor.
    I stopped the Crestor and the neck pain improved. Over the summer I had muscle pains in my arms and upper thighs that made movement very painful. I felt like I had a bad flu. I had all kinds of studies done, saw two rheumatologists and nothing was diagnosed. Finally they told me they thought it was statin drug related. The muscle pain was so severe I could not even take a bowl out of a cupboard, comb my hair, move my arms without severe pain.
    Over the fall I began having joint pain in my knees and fluid build up. The joint pain and muscle pain will get a little better and then worsen again. I cannot sleep well at night. It has been difficult keeping up with my job. I am exhausted much of the time. Still no one seems to be able to help me relieve the symptoms – I have even tried a homeopath. The symptoms have improved since last summer but still are present. It is like living with a chronic condition and the pain causes me to feel depressed. Climbing up and down stairs is very painful. I could go on and on… Any suggestions?

  6. Mark H
    Reply

    I have been on Simvastatin, Lipitor and now on Crestor for 8 yrs. I have had memory problems for some time but my biggest problem has been tingling, numb, cold and very painful feet. My cardiologist does not believe it is the statins but when I go off the drugs, I get much better. My primary, who is a former pharmacist, believes it is the statins and has reduce the Crestor from 10mg daily to 5mg 3 days per week. This has kept my LDL down to about 110 but not down to the desired 70. I am good with that because my feet feel much better.

  7. sld
    Reply

    I’m already a diabetic (type-2) and was put on Pravastatin which lasted one week. During that time I had leg cramps night and day, my urine turned brown and my blood suger was over 200.
    After a cardiac cath. ( in which I was told I had a healthy heart and clear coronary arteries) the cardiologist said a little knowledge was a bad thing when I told him of my side effects.
    I no longer take Coreg or Pravastatin and don’t plan to see that doctor again. My primary doctor is aware of these events. I welcome any comments you may have. Also, I have to be extra careful with the diabetes now.

  8. Dale
    Reply

    I was on Simvastatin for a couple of years and developed severe pain in my knee and shoulder. My knee was drained 3 times and I was told my knee needed to be replaced. I discontinued the Simvastatin and my ailments went away in only a few days. Today my knee and shoulder are fine and pain free. The odd thing is that my cholesterol level has never gone back up and that has been six years ago.

  9. cathy
    Reply

    that is so sad to hear your mum must have been so afraid…there are so many stories about side effects of statins…even when you stop taking them I don’t think you ever get rid of all the side effects…I took them for years ..5 different statins…I suffered pain and weakness in my arms and legs…I couldn’t walk upstairs…then I was told I had type 2 diabetes…I was in my early 60’s but felt like I was in my 80’s.
    I finally just told my gp I wasn’t taking anymore statins and stopped them 2 years ago…I felt better soon after ..but still have sore knees and hips…also my blood sugar has gone back to normal…I’ll never again take them…if I had known at the start that they could cause raised blood sugar …I never would have taken them…if it came to a choice between diabetes and high cholesterol…I know what I would have chosen..

  10. Tracy
    Reply

    Well after my post on march 31st I am pleased to say my husband is now completely back to the active happy man he used to be !! He feels so much better after being riddled with pain and tierdness. He has been off statins for 4 weeks now and will NEVER take another statin :-))))
    PEOPLE’S PHARMACY RESPONSE:
    We are delighted that your husband is doing so much better now, but we would caution that he does need to be proactive to prevent problems from his heart disease. With 4 stents, he is a candidate for careful follow-up.
    There are many ways to control cholesterol and other lipids (triglycerides, etc) besides taking statins. You may find this story of interest:
    http://www.peoplespharmacy.com/2013/04/22/natural-approaches-to-cholesterol-control/

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