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Zocor Muscle Injury Risk Leads to FDA Warning Over High Dose Simvastatin

Federal drug safety reviewers are calling for limits use of the highest dose of the cholesterol drug simvastatin, which is most commonly marketed as Zocor, saying that the 80 mg version carries an increased risk of muscle injury.

The FDA announced this week that it has completed a safety review of Zocor, and is recommending that no new patients be started on an 80 mg simvastatin regimen, due to the risk of myopathy and rhabdomyolysis; rare forms of muscle injury.

The Zocor drug safety communication also contains a list of drugs that should not be used in combination with Zocor, including the combination cholesterol drugs Vytorin and Simcor.

The FDA began reviewing the side effects of Zocor in March 2010, when it first warned of the possible increased risk of rhabdomyolysis and other muscle injuries.

According to the agency, about 4.9 out of every 100,000 people who are on an 80 mg Zocor prescription will be hospitalized for rhabdomyolysis, particularly within the first year of taking the drug, when the risk is highest.

As a result of its findings, the FDA is recommending that 80 mg Zocor only be given to people who have already used it for a year or more without problems. The agency is asking doctors not to start any new patients on doses that high. If patients do not achieve cholesterol control on 40 mg Zocor, FDA experts urge doctors to try them on another treatment instead of upping the dosage.

Zocor (simvastatin) is a synthetic statin developed by Merck & Co., which is also widely available as generic simvastatin. Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best selling cholesterol lowering drug in the world, bringing in $4.3 billion in 2005.

Simvastin is also used in combination with other drugs in Vytorin and Simcor. The FDA estimates that 2.1 million people were prescribed some drug containing simvastin in 2010.

Rhabdomyolysis from Zocor causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream. Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.

All statins have been found to carry a risk of muscle injury, known as myopathy, and rhabdomyolysis is the most severe form, potentially causing severe kidney damage, kidney failure and death. All statins currently contain a warning that myopathy and rhabdomyolysis are rare possible side effects.

Statins are among the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. Statin is used in a number of other popular cholesterol controlling drugs, including Crestor, Lipitor, Mevacor, Lescol and Pravachol.

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10 comments

  1. I. Annette Williams Reply

    Several years my doctor put me on Simvastatin. It did lower my cholesterol rather quickly. After several months, I began experiencing muscle weakness only in my lower body, which very gradually increased. I discussed with my physician and she assured me it wasn’t the medication as I would experience this throughout my entire body. On subsequent visits, my doctor (and her nurse), still argued that it was not the drug. During my visits they kept using the description “muscle pain” and I kept correcting them and telling them it was “muscle weakness.” They both got quite nasty with me. I finally took myself off the drug as the effects were getting worse. For months afterward I went through a myriad of symptoms from lower body muscle wasting, dry eyes to muscle cramps. I was previously a very active person, doing lots of walking and running in my weekend hobby of dog handling. At my worst point, if I walked 50 feet on a level surface, my lower body became so fatigued that I would have to stop and recover for a few minutes before I could continue. I would best describe it as similar to the effects of working out doing repetitions until the muscles simply can’t do any more. Then you sit or stretch and rest, then do more sets/repetitions of exercise. It has taken me a couple of years to get back to something near recovery, and I’m still at about 70% of my previous capacity. This has had and is continuing to have a major impact on my physical abilities.

  2. patricia Reply

    i had a heart attack feb 1 of this year and when i was sent home i had my simvistatin dosage changed from 20 mg to 80 mg. for the past 4 months i have had pain in my legs, starting just above the knees down. i went to my heart doctor and he did a dopplar test on both legs and ruled out p.a.d. i went to my family doctor today and tried to explain the pain i was having and he put me on lyraca.. i dont know which drug scares me the most. does anyone else have the burning pain in your legs?

  3. Tammy Reply

    Several years ago my doctor put me on Simvastatin. It did lower my cholesterol but not as much as my endocrinologist wanted. She increased my dose a couple of times. When I started taking 40mg I began experiencing muscle pain and weakness in my upper arms and shoulders after only two weeks. I thought I had overexerted in some way and believed these symptoms would go away. A month later I was feeling much worse, so much so that my husband had to help me to get dressed. I started to think that it may be my Simvastatin because the symptoms started only after my dose had been increased. I finally took myself off the drug as the effects were getting worse. I went to my family doctor and she assured me it wasn’t the medication as I would experience this throughout my entire body. My symptoms had gotten better, but I was still experiencing impairment in the use of my arms. I decided to see my family doctor and on this subsequent visit, my doctor still argued that it was not the drug and suggested that it may be arthritis. During my next visit with my endocrinologist I explained these symptoms to her, what my family doctor had said, and that she suggested that it might be arthritis. She ordered a test for arthritis, the results of which were negative, and I was told to follow up with my family doctor again. She also told me that my cholesterol had significantly increased and that I needed to be on some type of medicine. She prescribed Zetia, but it made me sick so I stopped taking it. I returned to my family doctor, but she still insisted that if my symptoms had been caused by the medicine, my whole body would be affected and the pain and weakness wouldn’t be localized in my upper arms and shoulders. My symptoms were getting better, but I still didn’t have full use of my arms and had continued pain and weakness. I had another visit with my endocrinologist and had still had high cholesterol. She suggested that since the Zetia made me sick that I take Crestor because even though it was a statin as well, it could be taken at a low dose and still be as effective as a high dose of Simvastatin. I started taking the Crestor and just as quickly as when I had my Simvastatin dose increased, I my symptoms started getting worse again. It has been about a year and a half since this all started and I have gotten back to something near recovery, but I continue to have pain, weakness, and impaired use of my arms. This has had and is continuing to have a major impact on my physical abilities.

  4. timothy Reply

    i started taking zocor on the advise of my doctor cause of my high colestorol levels my fondness for fried foods kinda got the best of me. after several months i dedcided to gradually nback away from the meds and now i am experincing muscle spasm in my right shoulder like you would not belive, at times it often occurs in the bones itself. it is to the point were i want surgery right away to cure this illness

  5. Penny Reply

    Trying to figure out if zocor is causing all my pain. I have been taking abt 7 years In the last 5 years I have had a rotator cuff tear, capsular release of same shoulder, tarsal tunnel in my ankle and now frozen shoulder in other shoulder. My doc wants to do capsular release on this. None of this runs in my family, I have been evaled by neurologist, rheumotologist and don’ t have diabetes . But I have been in pain so long, I don’ t know what it means to be pain free. My doc says it can’ t be the zocor. But ortho is just stumped why this keeps happening looking for advice

  6. Tim Reply

    I took this medicine and it has almost crippled me. I was off of it for about 2 years but I still have not returned to my previous health status. They have tested me for everything and the simvastatin was the problem.

  7. Veronica Reply

    I have been taking Zocor 40mg for about 4yrs. over that 4yrs I have been Dx diabetic, and complained of numerous muscle/joint pains in my back, knees, and legs. Just this past Aug. 2011 I ended up in the ER in such severe pain and with confusion. The doctors determined I have rhabdomyolosis from Zocor use. This explains so many of my strange pains! I have been out of work for several weeks and pray for comfort for all of us who are suffering!

  8. Josefina Reply

    I have my cholesterol at 259 and the doctor prescribe me sivastatin 20 mg. this is my first day. I read the comments and the side effects of taking this drug at 40 and 80 mg. I hope this does not happen with 20 mg. otherwise I would let you know. I am also changing my diet. Doctors sometimes do not accept that any drug that they prescribed could have some side effects.( My mother lived until 92 years old and she never took any drug, no cholesterol, no diabetes , no high pressure, God bless her) . but every person is different and some people believe only in organic diet, my father was a pharmacist and I believe in medicine, that\’s why I am starting to take sivastatin even when I read these side efffects. It is difficult to put on strict diet when you like to eat, but sometimes you do not have other choice is your health or your illness. I wish everybody and myself to be well and healthy!

  9. Josefina Reply

    I have my cholesterol at 259 and the doctor prescribe me sivastatin 20 mg. this is my first day. I read the comments and the side effects of taking this drug at 40 and 80 mg. I hope this does not happen with 20 mg. otherwise I would let you know. I am also changing my diet. Doctors sometimes do not accept that any drug that they prescribed could have some side effects.( My mother lived until 92 years old and she never took any drug, no cholesterol, no diabetes , no high pressure, God bless her) . but every person is different and some people believe only in organic diet, my father was a pharmacist and I believe in medicine, that\’s why I am starting to take sivastatin even when I read these side efffects. It is difficult to put on strict diet when you like to eat, but sometimes you do not have other choice is your health or your illness. I wish everybody and myself to be well and healthy!

  10. Kathleen Reply

    I was put on 025mg of Crestor, after being on other Statins and had complained of muscle pains: I take a Crestor every other day and also take COQ10 which is suppose to help eliminate the pain. The past several months my muscles and joints have been giving be awful pain especially on the upper legs, my Dr. really doesn’t do too much or is he concerned, he orders more blood work and then tells me that the liver is fine, although the last test came with high Calcium levels, and I do not take additional calcium, he ordered blood work again and calcium levels where normal and Cholesterol level down to 165: The pains and weakness is getting worse, and I am missing work, I feel like I have over exercised and the muscle pain is don’t going away. My Dr. asks if I have ever been on Paxal anti depressant????? What has this got to do with muscle pain, I think I will come off the Crestor medication and seek another Dr.

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