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FDA Issues New Warning About Statin Drug

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Statin drug warningThe FDA issued a new warning last week about the second most popular drug in America, simvastatin, better known as .

The FDA says that doctors should no longer prescribe simvastatin, a -lowering statin drug, at the highest approved dosage of 80 mg, as it has been linked to increased risk of muscle damage at this dose.

It’s well known that and weakness are a common side effect of all statin drugs, but there is more than just discomfort involved. The and weakness is actually a signal that the statin drugs are damaging muscle tissue, releasing dangerous proteins into the bloodstream as the muscle tissue is broken down. These proteins can damage the kidneys and eventually lead to a fatal complication, known as rhabdomyolysis.

The FDA has known since simvastatin was approved in 1991 that it carries a higher level of risk than other , especially at higher dosages. So, I ask, why did it take twenty years for them to issue this warning? And why, does their new warning include the caveat that patients have already been taking the 80 mg dose for a year without any apparent problems may continue to do so?

How many people have to die or suffer serious injury as result of taking simvastatin before the FDA takes more aggressive action to protect consumers? are quickly becoming a leading cause of death in the U.S., with the number reported increasing by leaps and bounds each year.

What do you think? Does the FDA warning go far enough? Should people continue to take Zocor at any dosage level? Should other statin drugs come with similar warnings?

Please leave a comment and share your thoughts below.

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30 responses to “FDA Issues New Warning About Statin Drug”

  1. Davetref says:

    This proves,once again that the FDA is under the control of the big pharmaceutical companies.

  2. Anonymous says:

    Statins are overall a quite safe class of drugs, millions of people take them everyday without problems. I would hope the FDA is making its recommendations based on data, which can change as we accumulate more and more data with time.  This is especially true with adverse events that are very rare, as it can take a lot of data to figure out that the drug is actually causing the adverse effect.   Also, simvastatin is off patent, meaning its not the cash cow it once was, although that could be your reason for invoking a conspiracy theory on why this high-dose was pulled…  
    “Should people continue to take Zocor at any dosage level?”  Why wouldn’t they if the evidence suggests that there are no adverse effects at lower dosages and if the evidence suggests they have positive effects?  With science we must make decisions based on data, not on our biases.

    • I would have to respectfully disagree about statins being “quite safe,” especially when weighed against the alternative means of lowering cholesterol and reducing overall cardiovascular risk factors (i.e. dietary and lifestyle changes). The clinical trials that supposedly demonstrate safety are funded by the drug companies themselves, and it’s come to light recently that the directors of such trials often selectively report adverse events that occur during the trial period. Read all about that here: http://stage.liveinthenow.com/article/avandia-too-dangerous-but-still-for-sale

      It’s true that many people take statins, and most don’t die as a direct result. However, side effects – ranging from muscle problems, nerve damage, memory loss and depression to liver trouble, sexual dysfunction and lowered immunity – affect the majority of people who take statins, to some degree. Independent studies have shown this to be the case, and very often, people who are experiencing these side effects chalk it up to “getting older.”

      Statins work by blocking cholesterol production in the liver, and at the same time interfere with the production of hormones and CoQ10. Statins are very effective at lowering total cholesterol levels, and, I believe that it’s for this reason that “lowering cholesterol” has been widely touted as a sure route to avoiding heart disease – the pharmaceutical companies are able to offer statins as a magic bullet for accomplishing this simple goal.

      However, it is becoming increasingly clear that elevated cholesterol is NOT the cause of heart disease, but merely a symptom of – and the body’s way of protecting itself from – chronic, systemic inflammation. (Elevated levels of inflammation markers such as c-reactive protein and homocysteine may be better indicators of heart disease risk.) So, while lowering cholesterol may help to prevent a heart attack, the (much) safer and more sustainable means of doing are dietary and lifestyle changes that address the underlying cause of the inflammation.

  3. Shirley says:

    I stopped taking lipitor around 3 years ago. I still get encouraged to take a statin drug by my MD. She
    says she knows I will not but has to tell me that I need one or she would not be doing her job. I had
    started falling. My legs just gave out. I still have a lot of discomfort in my legs and they seem to be
    very weak. Will this feeling ever go away?

    • Geminicin says:

      I have a statin induced neuropathy in my feet which I am getting substantial relief by doing accupuncture. My feet and legs feel almost back to normal!! I took 80mg for over 2years and was complaining of symptoms within the first 6months but the doctors would absolutely refuse to believe they were caused by the statin. If you cannot afford accupunture — go to a chiropractic school were they offer accupunture at very reduced rates if you have the students (who are supervised and have put in a lot of hours) do it. Depending on how long you have had your symptoms and how long you took a statin, it may take a few sessions to get complete relief, but it is worth it!

  4. Hdbg95 says:

    Is this really a new warning?  Once again Big Pharma and the FDA are more interested in money than the safely of patients… attempting to turn a blind eye to serious side effects, and then encouraging people to continue using/buying their products.  Do they have no shame?  There are safer and just as effective natural alternatives, but Big Pharma can’t make money there….

  5. Vincenta says:

    I was taking Lipitor, but stopped taking it on my own, after reading all the info on statins.  The first was memory issues.  The second and final straw was the increase in Lou Gehrig disease.  While it did bring my cholesterol down to 160, the side effects were too big a risk.  

  6. dan donat says:

      I am now on my third statin drug over the past 7 months and have experienced side effects with all of them.  Simvastatin was the worst one.  I then was given lovastain and has similar problems. I now take Red Rice Yeast but my cardiologist put me on a low dosage of pravastatin.  Because your Red Rice Yeast isn’t made by big pharma it can’t doe the job!

  7. Statins should be monitored by the physicians. Statins are dangerous and it will do more damage
    to the body then you can imagine. If you have to take any statin drug it should be accompanied
    with COQ10.
    Lotte de Roy

  8. LindaM says:

    The VA (Veterans Administration) gave me simvastatin for over three years before I finally wised up, learned about the side effects, and stopped taking the darned stuff.  The VA started me on 20 mg late in 2006, bumped me up to 40 mg, a year later, then raised this to 80 mg for the last 16 months or so.  It had only minimal effects on my cholesterol levels (runs naturally high on my mother’s side), though that might have been because I kept FORGETTING to take it and began suffering from the rebound effect that the doctors don’t warn you about (cholesterol levels rebound to higher than they were to start with).  I have a high pain tolerance due to having horses fall on me and due to suffering from carpal tunnel for over 25 years, so muscle pain might not have registered as ‘pain’ with me.  My carpal tunnel got worse, my memory and moods suffered horribly, plus I suffered from severe nasal congestion, which my VA doctor dismissed as not possibly being due to simvastatin (the Mayo Clinic’s website said otherwise when I decided to check on this one’s connection to simvastatin, which brought up a long list of other side effects and got me started researching the subject).  Yesterday, I learned that my vitamin D levels are super low (17 ng/mL). 

    My concern is that too many veterans are put on simvastatin for reasons other than health, since the VA gets a lot of funding to do research on simvastatin, yet many VA doctors don’t appear to be aware of the known side effects of the statins.  I wonder how many of our PTSD and brain trauma veterans are having things made worse by taking simvastatin, which is known to increase the risk of depression and other mood problems.  If it’s a side effect, it should be called a side effect, not something else.  We could save the country a lot of money by NOT prescribing statins, which would also cut down on the prescriptions needed to treat the side effects of the statins.

    • Dr Cornelis says:

      Taking statins will make you die sooner from other things than what the drug was standardly prescribed for. You can live a long life with certain ailments. Once you start acting on a symptom with a drug you introduce new effects that will produce a certain effect but that will not make you feel better or live longer. No you will probably feel a lot worse and in your mind this confirms that you are a very sick person. And so on and so on. We will prescribe you more drugs to counteract the side effects of the first drug. 
      You will live long enough with whatever you have.

  9. Red says:

    This is good info. I’m taking 10mg tab. at night. I will discuss this with my doctor at next visit.

  10. michael owens says:

    Again, profits before safety.

  11. […] Cholesterol-lowering statin medications like Lipitor and Crestor have been the #1 prescribed class of drugs in the U.S. for years. More than 215 million prescriptions add $14 billion to drug company coffers every year. A recent report from the government’s National Center for Health Statistics showed that an astounding 25% of Americans aged 45 and older take statins, compared to only 2% in 1994. (The drugs came on the market in 1987.) […]

  12. Jeo22 says:

    Ihave been taking 45mg simvatatin for years but now my cardiologist prescrives 80mg of pravastatin to replace it due to the FDA warning.  However,the VA pharmacy wil only fill the prescriptin for 40mg.  They said 80 was too strong.   I am confused.  Please advise. 

    • Dr Cornelis says:

      I know nothing about you, like age, condition and why you visit a cardiologist. You could have asked him WHY he changed his prescription.
      In general pharmacists know a lot more about medicine than doctors.
      Why don’t you take the 40 mg for a few months and then check with your doctor again

  13. […] on CoQ10-depleting statin drugs now, it would be exactly opposite. Lots of people who take statins complain of aches and pains, but as soon as they take CoQ10, these aches and pains […]

  14. […] researchers contend that the benefits of this class of drugs that reduce cholesterol still outweigh the risks, even for this segment of the populace, providing they have already been diagnosed with heart […]

  15. Lj-myatt says:

    I am a veteran who was given the 80 mg dose for over a year (after 2 years at 20-40 mg) before I learned that the increasing problems I was having were due to the statin.  One reason that it took so long for me to realize it is that I started suffering depression and memory issues almost right away (on the original 20-40 mg dose), plus I took aspirin for a longstanding case of carpal tunnel.  It wasn’t until I had been off statins entirely for over a year that it occurred to me just how much less aspirin I was taking than I had been taking that last year on simvastatin.  I also started suffering from hand tremors during my last year on simvastain — these tremors are gone now.  Veterans should be especially careful of prescriptions given by the VA because the VA gets a lot of funding to do research on simvastatin, gives out almost no information on side effects with its prescriptions for simvastatin, and has a history of being less than ethical in doing research on veterans (look up Adil Shamoo’s testimony before Congress on the subject during the late 1990s).

  16. I too, am a veteran and like some of you i was put on simsvastatin but i was on a very low dose and it had been about a year and i had some terrible pain cramps in my legs and a round my waist…it wasnt til i finally got a younger and female doctor that she knew what was going on…i had explained to her all the problems i was going thru with such a low dose…so she made a switch to pravastatin and its still at a low dose …i feel better but not completely over the leg pain cramps…it comes and it goes….sometimes it gets so bad i have to sit down and wait about 15 mins before i can continues what i was doing….i just wonder about any of these statins…thinks maybe they need to create something better and gives one more endurance….

    • Lj-myatt says:

      If you’re still having a lot of leg cramps, you might want to be tested for the SLCO1B1 transport gene (I think it is the one at *5).  A double mutation at this location makes you 17 times more likely to suffer from muscle damage when placed on a statin.  Also, it was a young, female doctor at the VA who bumped me up to the 80 mg dose in the first place.  While on statins, the lowest my total cholesterol got was 197, and then only after I had had to walk everywhere for about a month because my car died and I had no money for repairs or for a different vehicle at the time.  The next younger, female doctor I tried at the VA kept trying to push niacin on me.  I’ve since found a Canadian article that mentioned that people whose cholesterol does not readily respond to statins may have an undiagnosed hypothyroid condition.  Many people have subclinical hypothyroidism (symptoms of hypothyroidism but test results within ‘normal’ ranges).  Hypothyroidism is a risk factor for high cholesterol.  I’ve requested a complete thyroid panel, but my doctor at the VA refuses to get one for me.  Also, many studies indicate that women do not benefit all that much from statins, nor do older people.  Newer research indicates that inflammation is more of a factor in heart disease than is choleserol, and that vitamins B6 and B12 are important for heart health, as is folic acid.

  17. […] first talk about the often understated dangers associated with statin drugs. The FDA, Big Pharma and even most doctors are all guilty about making statin drugs seem safer than […]

  18. […] als gevolg van het nemen van statines laten een heel ander verhaal zien. Vorig jaar schreven we een artikel over nieuwe waarschuwingen voor statines. Het middel Simvastine mocht niet meer worden […]

  19. […] use of this medication as physicians with “low” access. Furthermore, with regard to the adverse outcomes from lipid treatment, physicians with restricted access displayed “significantly less” response in switching their […]

  20. John Moran says:

    I’ve taken statins for many years only to find they do more harm than good for me. I can’t count the number of diferent ones I’ve taken, including Zocor. Livalo, Lipitor, Crestor to name a few. I had severe muscle problems and sickness that would knock me off my feet. Doctors would keep trying different ones tiil they finally realized I couldn’t take them. I missed so much time from work it forced me into early retirement. I have deteriorated muscles and stilll have aches and pains. I’m very ticked off at the drug companies for putting these out there. They have taken a toll on my quality of life. Something has to be done about the drug companies and the FDA approvals. I believe the doctors are only relying on what the drug companies tell them.

  21. Bill Johnson says:

    I took statins for several years. The last was Lipitor which I stopped when I learned that the numbness in my feet, which was traveling up the front part of my leg, was caused by taking Lipitor.
    I told my Ex-Doctor, who immediately refused to listen, even after I gave him the JAMA Neurology references.

    Now I also have severe osteoarthritis in my left knee and hip.

    • Casie Terry says:

      That’s such a shame that your physician wasn’t more open to exploring other options. At least you we’re being an advocate for your own health!!!

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  23. Rebecca Fuller says:

    I have been taking Simvastatin for around 2 years. I have begun to have muscle aches especially in the legs, have had to go to a kidney specialist about my kidneys. I have endured sleepless nights , being very tired and at night my legs and feet hurt terribly. I have stopped taking Simvastatin for about 2 weeks with no improvement. Does anyone who has taken Statins know how long it takes to get this drug out of your system and begin feeling some relief?