FDA Guidelines On The Adverse Effects Of Statins Are Very Telling

| March 1, 2012 | Comments (8)

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. On the 28th of February, the FDA issued new guidelines regarding the management of individuals taking statins. You can read these guidelines here.

One of the potential adverse effects of statins is liver damage (statins actually work in the liver to impair cholesterol production there). Some doctors would therefore routinely monitor liver function in people on statins with blood tests. The FDA maintains that “serious liver injury” is “rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.”

The FDA remains aware, of course, that liver damage is a possibility, advising that: “There have been rare reports of serious liver problems in patients taking statins. Patients should notify their healthcare professional right away if they have the following symptoms: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-coloured urine; or yellowing of the skin or the whites of the eyes.”

The FDA guidelines also highlight the fact that statins can, in some, induce mental problems such as memory loss and confusion. Here’s what they have to say about this: “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 fact that such symptoms can take a long time to come on is a concern, because many doctors will not suspect that statins may be causing a symptom that develops 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.

The FDA, in its new guidelines, also draws our attention to the evidence which links statin use with impaired blood sugar control. The new guidelines warn doctors and patients alike about this. It adds, though, that: “[the] FDA continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.”

Just to remind ourselves, many individuals need to take statins for several years for one to avoid having a heart attack. 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 the risk/benefit ratio of statins is not so stacked in favour of ‘benefit’ as we have been led to believe.

Here’s to a healthy heart

Dr John Briffa
Editor
for The Cholesterol Truth

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Category: Statin Drugs Side Effects

Comments (8)

Testimonials are based on the personal experience of individuals. Results are not typical and the potential benefits of taking any drug or supplement may vary depending on your individual needs and health requirements. Please consult your GP before making any changes to your medical regimen.

  1. Marcia says:

    I was on Simvastatin for years and switched due to side effects to Atorvastatin Dec 14 – during 2015 I made several visits to the practice with general malaise and exhaustion, saw various GPs asked all of them if I this could be down to statins, all said no! ONe of them told be I was a well women and should go home! I finally ended up in hospital Feb 2016 and diagnosed with Eosinophallatic Faciittis and have been seriously unwell since ………..

    I will never take another statin and I no longer trust my GPs ……

  2. Pili says:

    Hello
    I am very confused as I read cholesterol is good for you…how much cholesterol is good for you?
    My husbands reads of cholesterol is always very high about 10 when the normal is 5, he has a good diet, exercise but I think this is hereditary as all his family has this high cholesterol levels. The moment he stops taking Lipitor his cholesterol goes high again.
    We have tried lecithin, artichoke, sterols, high vit bs complex, milk thistle, high fiber etc etc…
    My question is: Is it safe for him to stop Lipitor and go with a natural diet and leave the cholesterol be as high as 10…what can we do?
    Thank you very much.
    Pili

    • Editor says:

      Hi Pili,

      We cannot advise anyone to stop taking their statin drugs. However, we can reiterate the fact that a blanket treatment to lower patients’ cholesterol levels (so that everybody has the same ridiculously low levels) is grossly irresponsible. What is considered a ‘high’ reading for one patient, may very well be a ‘normal’ reading for another – our bodies are as individual and unique as our personalities.

      Apart from that, cholesterol is an essential building block used in every cell of your body… It is not the villain it is made out to be.

  3. My Dad was taking Rosuvastatin tablets and his Gp and changed him to different statins Atorvastatin 20mg but we do not know why!

    • Norman says:

      Doctors tend to lean towards patient compliance, and if the patient complains, they simply prescribe another statin. The results will be the same, and still they do not advise coenzyme Q10 or if over 55 years, they should recommend ubiquinol.
      Norman.

  4. Bill Davis says:

    Another big problem with taking statin drugs, which I have experienced personally, is that it is usually prescribed to prevent heart attacks or heart disease and it does not do that! I was told I needed to take statins to prevent the ‘widowmaker’. I haven’t had the ‘widowmaker’ but I have had 6 heart attacks 4 of which occurred while I was taking statins and one after ceasing the miracle drug treatment. In addition I suffered through many years of persistent muscle aches which caused many sleepless nights. Not a happy outcome. Thank You cardiologists and GPs with one lousey trick in your bag and it didn’t even work!

  5. Mrs.Sheila Innes says:

    Aged 79 my husband developed a heart problem for which he was given a tablet to treat it(can’t remember the name of it) and also Statins.He was very good at reading the papers in the boxes the tablets came in and one day,while reading the one in the heart tablets box, he exclaimed “It says here if you are taking these tablets you should not be taking Statins”. We both told two of the doctors he visited but neither of them was at all interested and more or less said it was rubbish!! He died last May. I am a retired nurse and since returning to U.K. after 35 years in Africa I find I have lost faith in the British Medical System. Maybe there are too many patients to be treated these days but I have the feeling doctors are not really interested in the patients,it is just another job. Also,I cannot understand why nurses are now trained at Universities rather than on the wards.Obviously they need to know and under-stand about different diseases but how can they learn and understand how to look after patients in a University? I learnt to look after patients on the ward and how to make them comfortable, then attended classes to learn about Medical Problems and how to deal with them. I didn’t see too much of the nursing care while my husband was in hospital before he died. I’m afraid I have lost faith in the Medical profession!!

  6. Richard C. Snouffer, MD says:

    A large part of the trouble statins can cause are due to the fact that they deplete the body of the EXTREMELY important Coenzyme Q10. This is easily replaced in supplement form and when so doing, most of the troubles statins cause go away. NOW–I am NOT advocating statin use. In my professional medical opinion, there are better ways to improve the cholesterol panel. However, if you ARE on a statin, talk to a doctor knowledgeable about CoQ10 to see about protecting yourself from statins’ harmful side effects and adverse outcomes.The Carlton Clinic can help you find out more about Coenzyme Q10 and cholesterol. See our FB page, or visit our website at: http://www.thecarltonclinic.com/Richard Snouffer, MDMedical Director, The Carlton Clinic, Anti Aging Preventive and Integrative Medicine

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Testimonials are based on the personal experience of individuals. Results are not typical and the potential benefits of taking any drug or supplement may vary depending on your individual needs and health requirements. Please consult your GP before making any changes to your medical regimen.




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