Statin pills and a warning sign

One of the most tragic diseases of mankind is amyotrophic lateral sclerosis (ALS). It is also known as Lou Gehrig’s disease. It is a mystery disease in that we do not know what causes it and we do not know how to cure it. Many people have asked whether there is an association between the use of statins and ALS.

What Is ALS?

Our muscles are controlled by nerves or neurons. To lift a pencil, kick a ball or step on the accelerator, our brain needs to send chemical messages to the motor neurons that control these voluntary muscles. If those nerve cells are damaged and die, we are diagnosed with motor neuron disease (MND).

Symptoms of ALS:

Symptoms of ALS often start with little things, like muscle weakness. There is incredible variability from one person to the next, so it can be challenging to describe a typical situation. Some people may find they start dropping things, like pens or coffee cups. Others may complain of poor hand-eye coordination. Many people develop difficulty walking, partly because legs and feet become weak and hard to control. Muscle cramps and uncontrollable muscle twitching in arms or legs (fasciculations) become noticeable.

Eventually, people with ALS find that their balance is affected and they may trip or fall easily. The voice is often affected. People develop slurred speech and/or swallowing problems. Family members frequently notice that the voice changes as the disease progresses.

As motor neurons continue to die, muscles become progressively weaker. Paralysis sets in and speech becomes increasingly challenging. Eating and drinking are especially difficult. The downward spiral takes a terrible toll on both patients and care givers.

Is There A Connection Between Statins and ALS?

Why would anyone ever consider that statin-type cholesterol-lowering drugs could be linked to ALS? As far as we can tell, the first published article on a possible linkage between statins and ALS was published in Drug Safety in 2007. The World Health Organization International Drug Monitoring group in Uppsala, Sweden detected a preliminary signal. It called this “ALS-like syndrome” and emphasized “the rarity of this possible association” with statins.

The following year the FDA published an intriguing article in the journal Pharmacoepidemiology and Drug Safety (online, Sept. 2008). It was titled “An Evaluation of a Data Mining Signal for Amyotrophic Lateral Sclerosis and Statins Detected in the FDA’s Spontaneous Adverse Event Reporting System.”

In the article the FDA staffers stated:

“Using techniques to data mine spontaneous-reported adverse event (AE) databases, we and others observed a disproportionate number of reports for ALS in association with statin use. Here we analyze data from post-marketing reports and clinical trials to gain a better understanding of the data mining signal for ALS and statins.”

The authors noted that of the 155,126 adverse events linked to statin use in 2006, 109 mentioned ALS, Lou Gehrig’s disease or motor neuron disease. The agency excluded 18 cases for various reasons. In its conclusions the staffers noted that they “found disproportionate reporting for ALS with statins when data mining the FDA’s AERS [adverse event reporting system].” These authors then went on to say that they doubted “the possibility that treatment with statins initiates this neurodegenerative disorder.”

Interestingly, the agency concluded this article with a caution:

“Nevertheless, given the expansive use of this class of drugs and the dire consequences of ALS, any degree of uncertainty justifies further investigation. To this end, there is an ongoing case-control study examining whether exposure to cholesterol-lowering drugs, including statins, increase the risk of developing ALS, or alter the disease progression of individuals with ALS (personal communication, Lorene M. Nelson, PhD).”

Beyond the FDA:

The same year that the FDA noted a statin-ALS signal, some neurologists published an article titled “Are Statin Medications Safe in Patients with ALS?” (It was published in the journal Amyotrophic Lateral Sclerosis, Aug. 2008). The authors concluded:

“This study has demonstrated a strong association between statin medications and an increased rate of functional decline and muscle cramping in patients with ALS. Although this association does not prove a causal relationship, it is prudent to exercise caution and discuss discontinuation or replacement of statin medications in patients with ALS.”

The FDA, Statins and ALS?

We have searched high and low for the case-control study the FDA referred to back in 2008. Perhaps we are just dense, but we have not been able to find any publication documenting a connection between statins and ALS or disproving this possibility.

Chinese researchers published a meta-analysis in 2013 in the journal Amyotrophic Lateral Sclerosis & Frontotemperal Dengeration (May, 2013). Out of 375 potentially relevant studies they could only locate three that could be analyzed. Their conclusion:

“No definite association was found between statin use and ALS incidence and progression. Current evidence is insufficient to draw definitive conclusions.”

On the one hand that seems very reassuring. On the other, it is a bit worrisome that after all these years we cannot draw definitive conclusions. The authors encourage further research on the question of an association between statins and ALS.

The Latest Research:

A study published in the journal Muscle & Nerve (Aug. 2016) is quite interesting. The researchers are from the departments of neurosurgery and neurology at the Penn State College of Medicine in Hershey, PA. They introduce their investigation with these insights:

“The etiology [cause] of amyotrophic lateral sclerosis (ALS) remains unknown. Environmental and genetic factors are believed to modify ALS risk or disease progression. These include statins, which may accelerate ALS disease progression…

“There is increasing interest in the effects of statins on ALS risk, disease progression, and survival. In patients with ALS, statins may accelerate disease progression and increase the frequency and severity of muscle cramping. Analysis of results from 2 clinical trials suggests greater functional decline in women with ALS who take statins. However, other studies have shown no association between statins and ALS risk or survival…”

These investigators studied special mice that are susceptible to ALS. They found that “statins accelerate disease progression and decrease survival” in this mouse model.

What About Patients?

We started writing about Statins and Lou Gehrig’s disease in 2007. That was after the first article appeared in Drug Safety. In 2009 we wrote about “Statins and ALS-Like Syndrome.” Here is a link to that article:

Are Cholesterol Drugs Linked to Lou Gehrig’s Disease?


Statins and ALS-Like Syndrome

At last count there were more than 600 comments associated with this article. Some are heartbreaking. Here are just a few of the many comments we have received over the years:

Jane in Ohio describes some worrisome symptoms:

“My husband is a vibrant, health-conscious man of 56. He eats fruit, vegetables, some meat and little junk food, if any. (Ice cream is his weakness.) He works out, lifts weights and hikes.

“He was put on Lipitor about 25 years ago. The doctors check blood work and he has a yearly physical. In the past six months he has started having muscle twitching in his neck and arm. He has leg cramps and back pain. His throat closes at times when he tries to swallow liquid. He chokes. His voice and speech and slurred. He feels healthy in every other way. They say it looks like ALS.”

Kevin shared this story about his mother:

“My mother took statin drugs for as long as I can remember. Although she was very much into fitness & followed her doctor’s regimen for diet, exercise & medicines, her cholesterol was never under 300.

“About four years ago she noticed that she would stumble on occasion & later developed ‘drop foot.’ Months later she was diagnosed with ALS. She died earlier this year at age 59, within 3 years of diagnosis.

“Through my own research about the disease, I had heard of a possible connection between statin drugs & ALS, but every doctor that I asked said there’s no evidence to support the connection. We’re in a sad state if we’re resting our hopes on the FDA to do something… And that’s a pretty powerful lobby drug companies have in Washington.”

Ann in St. Louis shared a chilling story:

“My mother took cholesterol-lowering drugs for years and
also died from ALS in August 2000. I had wondered about these drugs
being a cause of ALS and then about a year after her death, I read an
article that there may be a link between ALS and statins.

“Her symptoms started with severe leg pain which was so painful she had
to quit working. She fell and broke her hip in June 1995, recovered,
but had trouble walking and then fell and broke her ankle in April,
1997, and never was able to walk again and needed a wheelchair. The
disease was finally diagnosed in Nov. 1997 after much testing and a
muscle biopsy.

“This disease is hideous and I often wonder if mom would still be here
today if she would have stopped taking the statin drugs.”

The Bottom Line from the People’s Pharmacy:

What we hear from health professionals is that so many people are taking statins that it is hardly surprising that some of them would develop ALS. Not because of the statins but coincidental to the statins. That was seemingly the FDA’s position a decade ago. The agency pointed out that with so many people now on statins we should have seen a dramatic increase in ALS cases if there was a true connection. The FDA folks insist that has not happened. We hope they are right about that.

We found one article titled “The Epidemiology of ALS and the Role of Population-Based Registries.” published in Biochimica et Biophysica Acta (BBA) – Molecular Basis of Disease (Nov-Dec, 2006). In it the authors ask:

“Is the incidence of ALS increasing?
“There are several observations in the literature supporting the concept of an increasing incidence of ALS…”

Italian researchers report “an annual increase of approximately 2% throughout the 10-year [study] period.” Amyotrophic Lateral Sclerosis, online, July 6, 2011. There are other studies suggesting that there is a slight uptick in ALS cases (Neuroepidemiology, Aug. 2013).

Any Connection Between Statins and ALS Is Still Unclear:

ALS remains a relatively rare neurological disease. That said, we know that statins do affect both nerves and muscles in susceptible individuals. That is not in dispute. The latest animal research suggests that statins can have a negative impact on ALS mice. Whether some people are so vulnerable to this effect that they go on to develop an ALS-like syndrome remains unanswered.

We are the first to admit that it could all be a tempest in a teapot. But we surely would like to see some definitive research on this crucial topic. As the Penn State researchers point out, “New cholesterol management guidelines would increase the number of people eligible for statin therapy from 43 to 56 million.”

We encourage anyone with a story to share about statins and ALS to report it to the FDA’s MedWatch program. Because we are not always convinced that the FDA pays much attention to these reports, we also encourage you to share your story below in the comment section. We continue to pass these reports on to the FDA to encourage them to follow up on the case-control study they discussed in their 2007 article.

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  1. Diane

    My husband just died of ALS — he too was on statin drugs for a few years. Finally the evidence of a connection is starting to show up. What a tragedy that so many lives are being taken by this horrific disease. My family is heartbroken. How many people will have to die before the FDA puts out a warning?

  2. Chris

    My sister took statins for 10 years and died of motor neuron disease (als).
    They are totally bad and unnecessary and driven by the pharmaceutical companies who set the guidelines for our health. Everyone should get off them! Cholesterol is absolutely necessary for our bodies to function.

  3. gardensnake

    I am sure there is a connection (with some people its pure poison). In a certain stage the muscles will keep breaking down (ALS). when you feel weakness during taking statins, please stop directly and take ubiquinol, fish/cbd/thc/coconut oil, etc. (see other forums on internet, search for example; statins recovery, also advise red bush/rooibos herp) before it’s to late.

    Don’t listen to the standard doctors (the will advise you take other brands, or take less mg). Doctors can’t tell exactly the cause of ALS, but the can tell it’s not from the statins??

  4. Aryeh
    York, Pa

    I can only tell you about my own personal experience with statins. I believe it triggered my ALS. I know this because the day I stopped taking it, I reached homeostasis. Your own experience may differ. There was a class action for those taking 80mg. and above. I was only taking 20mg.

    • Rebekah

      Can you tell me more about the class action suit?

  5. Joanne

    It isn’t surprising that there is no definitive answer. When Science still can’t say whether coffee if good or bad, coming out and citing that statins could cause ALS would be a fight the size of which we have never seen. I believe the Drug lobby would prevail. A friend is in the last stages of ALS and I feel that any possibility that my the atorvastaton I take can cause such a horrible disease isn’t worth whatever benefit it supplies. I will discuss it with my GP but at age 75, I feel less than comfortable knowing there might be any connection with ALS.

  6. ryan

    Chloe Ryan
    My dad was diagnosed with ALS. He does not have ALS anymore.ALS herbal remedies i purchased online from Dr Lauren (Good Health Herbs Home) cured my day ALS .pleases anyone out there with ALS,natural herbal remedy is the real things to use, No more toxic medication that clearly state ‘lead to death’. Let real and natural herbal remedy be your medicine. Stay away from vaccines and Dr Lauren for your ALS cure

    • Rebekah

      How far along was your Dad when he went to see Dr. Laura? I’m intrigued by the “cure” he experienced.

  7. Sheilagh

    Statins poison the mevalonic acid pathway at its very beginning. The mevalonic acid pathway is necessary for life, making numerous hormones and more, CoQ10 for example. Apparently most statins have a somewhat short half life so your body can clear them and try to repair the damage but Crestor has a 19 hour half life so your body can never completely clear it. My husband took Crestor for 6 years before the foot drop started. His doc took him off the statins but the destruction had begun. Within 4 months he was diagnosed with ALS. The paralysis continues to creep upward. I would like to know if long lasting Crestor causes more motor neuron disease than other statins.

    • Bindler
      E U

      My friend Henri was on Crestor 20mg for 2 years he has ALS since 18 months… did you found some kind of treatment ?

  8. Sandra
    Raleigh NC

    Hi, my brother in law died of respiratory onset ALS in November 2016 with a confirmed diagnosis made in August 2016. He was 69 years old, and obviously the progression of ALS was extremely rapid. He took Crestor 5 mg daily religiously for 8 years prior. The Crestor caused fatigue from the beginning but he continued it. We will always wonder if taking Crestor combined with as yet unknown risk factors caused his ALS. He was tested and did not have any know genetics for familial ALS.

  9. Jill

    My mother-in-law died from ALS only 4 months after her diagnosis. It was the most accelerated case I have ever seen. Her doctors’ persistent prescribing of statin drugs for her high cholesterol levels either caused her ALS symptoms or caused an acceleration of her disease. I believe wholeheartedly that it was the former. Funny how the doctors couldn’t see ANY relationship to taking the statins and her rapidly declining health, yet one of the first things they did was take her off the Crestor immediately! Unfortunately, it was waaaaay past too late for that. What a shameful loss of a wonderful woman at only age 68. Her family misses her more than words can say… Please encourage more research into the statin drug/ALS connection!

  10. Hoss

    Ran for many years to keep my cholestroel down until 3 yrs ago had to stopp running due to hypotrophic cardiomyopathy. Cardiologist put me on statin drug to control plaque buildup in my heat and arteries.

    Less than 6 months, I began feeling weakness in my upper arms. Muscle atrophy has since made it hard to dress and feed myself. I was diagnosed with ALS 2 years after my hypertrophic myopathy. I believe there is some connection but my doctors do not agree.

  11. Lynn
    Campbell, CA

    I wonder about a lot of drugs but the doctors seem to ignore any symptoms from them. I wonder about the FDA which makes a lot of money from drugs. It seems they will not admit or take many drugs off the market unless its not a money maker. I read the side effects of statins and will be off most of them as soon as I can. I am completely off Prilosec now and almost had a nervous breakdown. I gave up my cholesterol drug. I have cramps in my feet & legs so bad from side effects of these drugs.

    • Joanne

      I too have IHSS and now am double sure I will stop taking my statin. Thank you for posting.

  12. Pamela D.
    Chapel Hill

    I have suspected this correlation, as well. As a registered nurse, I have certainly observed the increase of ALS in the last 30 years, and resisted the suggestion by my MD to “perhaps try Lipitor” for cholesterol numbers that I don’t feel warrant it. I also believe that MDs, for the most part, are pawns for the drug salesmen peddling their wares.

  13. Sylvia

    Another nerve disease and yet no researcher has looked into the fact that cholesterol is necessary to make allopregnanolone which makes progesterone which is a neurotransmitter and is involved in forming myelin, the sheath that protects nerves. Why is progesterone ignored in neurological conditions??

    • Mary W
      South Carolina

      It appears many “professionals” do not know any of the physiology, which they were supposed to have learned in College. The body has to have cholesterol to make the normal hormones which control every aspect of our complicated body systems. The brain is made of cholesterol and when you start manipulating the intricate processes, you INVITE all types of damage, dysfunction of all normal body processes.

      But then Big Pharm would lose all their millions of dollars. I am a nurse and have observed so much damage, pain, suffering caused by the incorrect use of medications.

  14. Mary

    There have been so many listed side effects from statin drugs. With that track record, why take a chance when they also have very few if any benefits for most of us?

  15. Lyn

    In my late 30s I was on Lipitor for cholesterol over 300. After about seven years and with Prempro and Zoloft added to the mix I developed trigger fingers sore feet and muscle cramps in my calves . I took a drug holiday and the pains went away. I try to start back on Crestor but the pains cramps came back. Over the years they continue to try me on different statins all with the same effect within a couple of days. after the last dose of Livalo,only two days,the cramps Have never gone away and in fact are spreading. For some reason when I take 50 mg of zinc a day the cramps and weakness abate.

  16. António

    My mother was statinated for 23 years (from her 55 to 78). She developed MND, was not able to walk properly, often felt onde ground. Neurologists and orthopedists denied any relation to statins. 9 years ago she stopped statins, partially recovered control of her legs, and walking was also improved. Nos I ask what does EVIDENCE BASED MEDICINE mean?

  17. Ali

    During the time of Lou Gehrig, there were no Statin drugs. I would question the theory.

  18. Deloris

    I think the most serious problem for statin-treated patients who present with muscle and nerve problems is getting a correct diagnosis after diligent examinations and testing. I saw a neurologist who incorrectly diagnosed my problem as soon as she met me (poor circulation she said). I had to demand more testing and came away with a grudging diagnosis of denervation atrophy, overlooking the mitochondrial mutations seen on my muscle biopsy and even denying any myopathy. My condition has worsened in the 4 and a half years since with no hope of treatment or reversal. I could pursue second, third, and even fourth opinions, but since all of the doctors I have seen refuse to link my condition to statins, what’s the point?

    • sally

      This doesn’t mean that all ALS is caused by statins just that some ALS is caused by station. Perhaps statins are a contributing factor for some people.

    • Nancy

      Delores, Your story sounds just like mine. I had to fight to get biopsy and I have denervation atrophy and myopathy. I also have mitochondrial mutations. My doctors have done the same thing, downplayed any myopathy and refused further mito testing even though genetics reports suggest further testing. I have atrophy of my thenar muscle and feet. My last EMG showed the denervation in 3 limbs but the doc said “all I am diagnosing you now with is distal axonal neuropathy.” I believe I have a slow progressing ALS like syndrome since I was already told I have damage to my motor neurons. I am sorry you have to go through this, I know how sick you are :(

  19. Jon Bayer

    I have been on statins for many years (20) atleast. I have now developed neuropathy in my legs and hands..My doctor says it was caused by lack of B12…I have complained to my cadio doctor that the statins may be affecting my nerve function, but he offers no alternative. I cannot prove it scientifically, but I strongly feel statins have affected my quality of life.
    In addition, I just lost a close friend who developed als type symptoms, could not swallow and passed away at the age of 69.

    • Mary

      B12 is one critical nutrient statin drugs deplete. Metformin is another where that happens.

      I have read that statin drugs in elderly women are useless. Google that and get more information. Not sure if the same thing applies to elderly males.

  20. Janet

    Cholesterol is vital to cell health; we would die without cholesterol.
    If you consider ALS under the broader category of a nuero-degenerative disease, similar to Alzheimer’s or Parkinson’s, the value of cholesterol to brain health has been shown. Reducing it through statins may contribute to these diseases.

    You already had Dr Perlmutter on Show 927 about Grain Brain. For another book and author that makes the information accessible yet filled with study references, I recommend The Alzheimer’s Antidote by Amy Berger. Your listeners would enjoy her clear explanations about the vital functions of cholesterol in the brain from the chapter, Cholesterol: The Brain’s Best Friend.
    She can be found at the website TuitNutrition, and for locals, the new print version of her book is in Wake County Library.

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