The FDA issues new warnings about statins

The Food and Drug Administration (FDA) in the US is responsible for making decisions about which drugs should be licensed. It also keeps a database of information regarding the adverse effects of drugs, and occasionally revises the warnings issued with prescription medication. Earlier this week, the FDA issued new guidelines regarding the management of individuals taking statins.

The FDA, in its new guidelines, draws our attention to the evidence which links statin use with impaired blood sugar control, and the guidelines warn doctors and patients alike about this. Raised blood sugar levels may ultimately lead someone down a path to type 2 diabetes. However, even in the absence of type 2 diabetes, raised blood sugar levels can damage the body and are associated with an enhanced risk of chronic disease and death.

The FDA guidelines also highlight the fact that statins can, in some, induce mental problems such as memory loss and confusion, telling us that: “There have been rare post-marketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These reported symptoms are generally not serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).”

The potentially brain-sapping properties of statins may possibly be directly related to their ability to deplete cholesterol. Cholesterol is very concentrated in the brain, where it contribute to the functioning of ‘synapses’ – tiny gaps between cells which allows nerves to communicate with each other.

It has been noted that those who take statins (which reduce cholesterol) are at reduced risk of dementia and ‘cognitive decline’ in later life. This evidence appears, at first sight, to contradict the idea that cholesterol has an important and critical role to play to brain function. However, one problem with this line of evidence is that it is subject to what is known as the ‘healthy user effect’.

Basically, what this means is that people who take statins are likely to be inherently healthier than those who do not. Not because they are taking statins, but because they are, say, more health conscious, and do not have a pre-existing medical condition which precludes them from taking statins. Because of the healthy user effect, we can draw no firm conclusions about this sort of evidence.

A recent review published in the Journal of Alzheimer’s disease [1] makes the point that in clinical studies in which people are treated with statins, no improvements in brain function in later life have been noted. This issue was actually reviewed back in 2009 [2]. In two well-designed studies which involved over 26,000 people, treatment with statins was not found to benefit brain function. The author of the review in the Journal of Alzheimer’s disease points out that lowering cholesterol levels may actually impair brain functioning, at least in part because of the role that it plays in the synapses.

There is at least some evidence for this in the form of a study which linked lower cholesterol levels in men with heightened risk of depression [3]. This study cannot be used to conclude that low cholesterol causes depression, but the finding is suspicious nonetheless. In a review of the literature, it was concluded that: “low cholesterol levels in serum are associated and related to different neuropsychiatric disorders. Lowered cholesterol levels seem likely to be linked to higher rates of early death, suicide, aggressive and violent behaviour, personality disorders, and possibly depression, dementia and penal confinement among young males.” [4].

The fact that mental symptoms such as memory loss and confusion can take a long time to come on is a concern, because many doctors will not suspect that statins may be causing symptoms that develop months or years after a drug is commenced. There’s a good chance, therefore, that many problems genuinely induced by statins will go undetected. In other words, such mental problems may not be as rare as the FDA and many medical practitioners think.

And what of the benefits of statins? Just to remind ourselves, many individuals need to take statins for several years for one, say, to avoid having a heart attack or stroke. What this means, is that the vast majority of people who take statins will not benefit from them at all. Also, the majority of people who take statins are essentially healthy (no history of, say, heart disease or stroke). In these people, statins do not reduce overall risk of death over time. What this means is that for the great majority of people, taking statins will not extend their life by a single day.

The new guidelines issued by the FDA only serve, I think, to remind us that risk-benefit ratio of statins is not so stacked in favour of benefit as we have been led to believe.


1. Vilet PV. Cholesterol and Late-Life Cognitive Decline. J Alzheimers Dis 2012 Jan 20. [Epub ahead of print]

2. Mc Guinness B, et al. Statins for the prevention of dementia. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003160.

3. Ancelin ML, et al. Gender and genotype modulation of the association between lipid levels and depressive symptomatology in community-dwelling elderly (the ESPRIT study). Biol Psychiatry 2010;68(2):125-32

4. Martinez-Carpio PA, et al. Relation between cholesterol levels and neuropsychiatric disorders. Rev Neurol 2009;48(5):261-4

17 Responses to The FDA issues new warnings about statins

  1. Feona 2 March 2012 at 9:16 pm #

    Yet more evidence against taking statins then! Just one thought: surely a ‘healthy user’ who is more health conscious wouldn’t be daft enough to take statins?

  2. Helen 2 March 2012 at 9:41 pm #

    An in-law was prescribed satins once he reached his early 70s because a routine health check (here in the UK) revealed the fact that his cholesterol had risen a little over the upper ‘safe’ limit. His own father had died after several strokes in his 90s, but then he had a less healthy diet and much less exercise than my in-law. The GP took note of the family history though. My in-law was put on statins. The muscle pain and weakness started, so In-law stopped taking his twice-weekly 15 mile hikes in the hills. A follow-up medical: “Oh dear, Mr ___, you now appear to have Type II diabetes, and your blood pressure is too high. Here are some more pills…” Thus was a fit man, still working part-time, reduced to a sedentary, pill-popping shadow of his former self. He doesn’t question the doc though, even with a background in statistical analysis. I think it’s a generation thing.

  3. Matty Maccaro 2 March 2012 at 10:04 pm #

    Here in the states, there are doctors who are so convinced of statin benefits, they would have statins put in the water supply. These folks buy into BigPharma lies and look to cholesterol numbers only. Statins are super profitable and people are gullible. After heart surgery, I was placed on statins, for months I could barely walk, became depressed and was confused. Many times, I asked doctors “could it be the statins”. Their denial was intense. When I stopped the statins, I began taking CoQ10, more Omega 3 fish oils and alpha lipoic acid, simple supplements which brought back my energy levels, took away the muscular pain and cleared up the brain fog. It as if our doctors engage in “magical thinking”, they seem to believe that if you take that “miraculous” statin all will be well. Science proves otherwise, but they cling to the statin idea which makes me wonder if they have stock in this most profitable drug or if they have just become hypnotized by BigPharma reps. Sure cholesterol numbers will plummet, but at what cost. Please take responsibility for your own health, ask questions then check reputable sources online. An ongoing study at the Univ. of California at San Diego, is worth taking a look at. It is called the Statin Effects study. The mild FDA announcement is old news, 8 years ago the memory loss and muscle pain was well known.
    Thank you, Dr. Briffa, for keeping these issues in the public eye.

  4. hilda glickman 2 March 2012 at 10:54 pm #

    Years ago Adele Davis wrote that high blood cholesterol just meant that the body was not utilising it properl because of lack of the right nutrients such as choline and inositol in lecithin. Where you have cholesterol as in eggs you have lecithin to emulify it. Cholesterol is need all over the body but it must be in small droplets and not oxidised.

  5. kate 3 March 2012 at 1:10 am #

    I do not know the way warnings are handled in the U.K., but here, there is a printed sheet attached to prescription drugs when they are purchased at a pharmacy (where prescription drugs are dispensed). Every single prescription drug has this – and there is no reason why statins should be any different. I can’t think why the FDA would have a warning printed on the container, except as some sort of silent acknowledgment that people tend to skip reading the attached paper that comes with a drug.

    Aspirin comes with a warning printed on the container – because it is not a prescription drug, and is sold over the counter. Yet thousands of Americans take aspirin every day, without worry that it will send them to the ER. Something about bleeding – in the intestinal tract or brain.

    Taking responsibility for your own health means discussing every drug you take – over the counter or by prescription. Not rejecting statins because ‘this proves they are bad for you’! Statins are prescribed for individuals. And in varying dosages – and for people who have different risk profiles – which their doctors know.

  6. anthony Kerstein 3 March 2012 at 1:34 am #

    Among other things statins are anti coagulants and are therefore conta-indicated for haemorrhagic stroke. Long before having mine (which I thankfully recovered very quickly from) I stopped taking statins because of muscle aches and memory loss and an excellent book called the Great Cholesterol Con by Malcolm Kendrick. Not taking statins may have saved my life or at least serious disability.

  7. mike pollard 3 March 2012 at 3:12 am #

    Now that patents are expiring and statins are being pushed as a harmless over the counter drug, the pharmaceutical companies are increasingly clutching at straws for their miracle life savers.
    I amuse my self keeping an eye out for the ‘beneficial’ side effects of statins. As well as helping brain injury recovery it reduces the risk of Alzheimer’s and those with psoriasis can look forward to a better future.
    Here’s the latest:

  8. mamaprophet 3 March 2012 at 1:09 pm #

    My sister has had heart surgery and therefore takes statins but she is in absolute agony with her joints and leg pains, I have talked to her about the affects of statins but she is terrified of coming off them incase she has a heart attack or stroke, does anybody know what the risks would be if she did. She has no quality to her life because of the constant pain she is in.

  9. Nigel Kinbrum 3 March 2012 at 5:38 pm #

    I always refused statins when my GP wanted to improve my out-of-whack lipids. Having corrected Vitamin D insufficiency and lost shed-loads of weight by controlling my carb intake & being as active as I can, I can now eat whatever I like and still get slimmer/lose weight. I can eat “safe starches” without suffering from severe lethargy followed by ravenous hunger. I am no longer a “carb cripple”. I am now taking zero medications other than a couple of hormone replacements due to pituitary failure.

    If statins save lives by lowering cholesterol, how come other cholesterol-lowering drugs are useless at reducing all-cause mortality?

  10. Lori 3 March 2012 at 10:08 pm #

    @mamaprophet, have your sister ask her doctor for evidence that statins reduce mortality in women. I’ve never investigated this myself, but I’ve heard others say there isn’t any such evidence. Some light reading:

  11. ryansmilla 4 March 2012 at 12:42 pm #

    It is extremely difficult for patients to fend off statins.

    I am a nutritional therapist. I also have familial hypercholesterolaemia (an inherited condition, which causes high cholesterol levels regardless of diet). My GP prescribed statins when I was 21 and I took them for years. Although I didn’t experience any noticable side effects, I stopped taking them after approx. eight years as I learned more about the drug.

    Now I am fairly educated about cholesterol and statins and yet every. single. time. I have a medical and a doctor spots my cholesterol levels I am being urged to take statins. Because of my background as a complementary health practitioner I know what to say, but I can see how a lot of patients would be bullied into taking the drug.

  12. Karen Green 5 March 2012 at 4:18 pm #

    As a heart patient, I research and monitor many sites for factual information. I am very grateful to likes of you, who are brave enough to provide people like me with the knowledge to make my own informed decision taking responsibility for my own health.
    With reference to your recent findings. Interestingly, this warning includes impaired blood sugar control. I took high doses of Niaspan (B3) to increase my HDL – this caused a diagnosis of Insulin resistance. My GP could only tell me that it must be my diet! I purchased a glucose testing kit as I knew my healthy diet was not to blame. Process of elimination revealed Niaspan I ceased this and my glucose levels returned to normal, confirmed by blood test too. Also, a Niaspan drug trial was pulled last year A week earlier a panel of health advisers said another Abbott drug, Trilipix, should be re-labeled to indicate that it failed to lower heart attacks in a study of diabetics.
    Should we / they even be playing with Cholesterol?
    My personal choice is not to address the Cholesterol issue at all – although, I have to have faith in something! I’m trusting in research that says inflammation, Homocysteine and free radicals are the risk factor that may be addressed by Vitamins, Amino acids and Minerals. So far, Magnesium has stopped my angina symptoms for the past 1 1/2 years…. among a host of other (quality, non high street) supplements.
    Thank you for being a wonderful reference point!

  13. Clive 5 March 2012 at 8:32 pm #

    I had a triple- bypass eleven years ago and was put on statins. I stopped taking Simvastatin for two months, after a visit to my doctors he said he felt I should start taking them again. The reason given was it was not so much the cholestrol lowering properties but there ability to stop the arteries from furring up. I do worry about taking this drug and to reduce risks I take CoQ10, Vit D and Omega 3 fish oil. Also regular exercise but what are the alternatives?

  14. simona 14 March 2012 at 10:11 pm #

    Unfortunately, this is what we get from some doctors writing in the press:
    Statins’ benefits far outweigh the side effects.

    All those millions of people taking them, is there an overall reduction in ‘vascular problems’ and heart attacks?

  15. Troy Dutton 12 November 2013 at 10:32 pm #

    I took Lipitor 10mg for several years, but quit when I realized that it was causing both memory problems and slurring of words. Now I control my cholesterol with diet alone.

  16. Tony Kerstein 17 December 2013 at 9:08 pm #

    Quite apart from anything else, slim fit people with low cholesterol (or to be accurate, low LDL) also get strokes and heart attacks. It would be interesting to know what percentage of of the total they are.

    Malcolm Kendrick (page 95 The Great Cholesterol Con) writes of a 1989 study in the Lancet of 92 women in a French nursing home, most of whom died over the next 5 years. The lowest mortality rate was amongst those with an average cholesterol level of 7 mmol/1 and the highest mortality rate (5.2 times higher) was amongst those with an average of 4 mmol/1. It’s a small study, but if the stainators got a result like this they would be trumpeting it all over the media.


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