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Recall of Zocor 80mg Dose Should Have Been Issued: Consumer Group

The FDA did not go far enough in restricting the use of high doses of the cholesterol drug Zocor, and approval for 80 mg simvastatin medications should have been withdrawn according to Public Citizen, a prominent consumer group. 

Public Citizen has placed the Zocor 80 mg doses on its “Do Not Use” list, following an FDA warning about the risk of serious and potentially life-threatening muscle damage from Zocor that was issued earlier this week.

The FDA announced June 8 that it is recommending that no new patients be started on an 80 mg Zocor (simvastatin) regimen, due to the risk of myopathy, rhabdomyolysis, kidney damage and other muscle injury.

However, instead of issuing a Zocor recall for the 80 mg dose, the FDA allowed doctors to continue prescribe the medication to patients at the highest dose as long as they had taken it for at least a year without ill effects.

Public Citizen has indicated that the FDA did not go far enough and should have issued an outright ban on the high dose version of Zocor, according to a statement made in it’s Worst Pills, Best Pills newsletter. The consumer group has designed Zocor 80mg as a “Do Not Use” medication, and urged all consumers, including those who had taken Zocor 80 mg without any problem so far, to consider switching to another medication or lower Zocor dosage. However, the organization cautioned that patients should check with their doctors before ending any drug treatment.

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.

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.

All statins have been found to carry a risk of 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.

Since the FDA warnings were issued this week, a number of Zocor lawyers are now evaluating potential lawsuits for individuals who developed muscle damage after taking 80 mg doses of simvastatin, arguing that the manufacturer has provided inadequate warnings about the potential risk.

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22 comments

  1. Chris Reply

    I was prescribed Simvastation after a second heart attack. I have developed muscle soreness and discomfort which I am being trated for. Could this be a result of taking this medication?

  2. Terry Reply

    Finally this comes out, My wife had so much damage was done to her.

  3. bahaa Reply

    I use zocor 20 for 3 years now .. is there any risk if i continue ?

  4. teck Reply

    the recall should be for simvastatin Not zocor, very very few people are using zocor (brand)
    the maker of zocor is trying to show the world they care about patients but it’s too late they already made the money !!

  5. Joy Reply

    Typical crap – high profits at the expense of hurting people… both the FDA and Pharmaceutical companies should be held liable for all damages… these executives are really pathetic, and the medical community stands by and does nothing about it…

    It’s very sad when it’s considered more profitable to “treat” than to “Cure”…

  6. Sara Reply

    My father died 13 days ago from rhabdomyolysis related to simvastatin. He also had a history of cirrhosis which was stable since he quit drinking 4 years ago. Despite having asked his doctors to lower his dose from 80 mg to 40, since his cholesterol was not very high, they would not. Nor did they check a CK, a test that would have picked up the rhabdo, when he started complaining of generalized pain after 1 week. He died a miserable painful death.

  7. Willie Reply

    I have been on zocor for years, and for years I have told my dr. about that pain in my muscles and WAS TOLD :OH thats normal just take it !!!

  8. Linda Reply

    My husband was on SImvastatin 80 mgs for years since heart surgery. He has increased pain over the years and constantly taking pain meds. Drs kept telling him arthiritis and aging. He got off the simvastatin 6 weeks ago on his own… WOW!!! What a huge difference and he realized what was causing so much pain. And now this comes out, years later?

  9. Christopher Reply

    I went through rhabdo back in 2005 after taking 4 doses of the 80mg pill. Was on my death bed twice because of it. First from the rhabdo and second (a week later)from the pulmonary embolism and DVT from all of the wasted muscle tissue in my bloodstream. No lawyers would accept my case back then. After this new info was released the first one I called jumped right on it and wants me to use there services. Wow!

  10. Henry Reply

    I have been on zorcor for at least 20 years. It started with 20mg, progressed to 40mg and I have been on 80 mg for the last 10 years..I do expierence leg cramps, muscle weakness and soreness in different parts of my boby.I am retired military and this medication was presribed by their clinic. I retired on i july 1974 and was not on zocor at that time..

  11. Helen Reply

    I was prescribed simvastatin 80mg (Feb 2011) when I had a mini stroke and was taking this medication for less than 3 months when I had to rush to the hospital Emergency Room (May 2011). I was diagnosed with acute rhabdomyolysis and was on 3 bags of intravenous fluid non-stop for 14 days to flush this poison out of my system. Fortunately for me, I was never on any type of medication as the doctors were concerned that this drug can cause damage to my liver as well as my heart. I just contacted the FDA and they sent me a form called MedWatch to fill out which is their way of tracking complaints from patients & dr’s. and also informing the public. Recently there have been a # of articles and news coverage (Channel 2 & 7) about Statin 80mg warning Dr’s not to perscribe this high dosage. I now question how this drug was approved & passed by the FDA and the Pharmaceutical companies. When I spoke to my Dr. who was treating me for acute rhabdomyolysis she stated that over 87% of her patients that had a stroke are on this drug and that my reaction was rare. I think the news media needs to inform the public what criteria the FDA & pharmiaceutical companies use when issuing their approval and also hold the pharmaceutical companies responsible. Perhaps by doing this our medical cost/insurance/ medicare/medicade will not be in the trouble it’s in and drugs will be monitored with a lot more care.

  12. sarah Reply

    i could not figure out why i was having so much muscle pain and my muscle was tighting up and i was having chest pain now i know it was coming from the zocor 80 mg.

  13. Carol Reply

    If you’re thinking of coming of this medicine, please please please have blood-work done beforehand. My 50-year husband came off the medicine after email communications with his doctor and died of a heart attack one month later – is it related? I don’t know, but I will always have questions.

  14. Martin Reply

    In December 2003, I had a heart attack and was put on 40mg of Lipitor, had major leg pain right away, changed to crestor same thing, then went to Zocor 40mg. had leg pain Dr. said was usual side effect and to keep taking it. in July 2009 my cholestrole started going up so he increased the Zocor to 80 Mg. My leg pain started to get worse to where I couldnt even walk up a short flight of stairs at work, had to take the elevator. Finally talked to the Dr. in Sept of 2010, He told me to stop taking the Zocor because the pain was now constant 24/7 and the muscles in my legs were now starting to have Myopathy caused by the Zocor which is stated in the Drug Mfg. statement of side effects. I continued to have major problems which would take a lot of space. in Oct 2010 I retired from state service after 33 years then in March of 2011 I was diganoised with MORVAN SYNDROME one of the rarest syndroms, There are less then 300 people through the world who have been diganoise with this. I now walk with a cane for short distance about 100 feet or have to use a wheel chair. This all because the Dr. and I beleived what the FDA and the Drug MFG. told us would keep me healthy!!!

  15. Don K Reply

    Went to my doctor today because the muscle pain in my legs and arms was getting so bad. My joint pain was traveling from toes, to knees, to shoulders, elbow and wrist all on the right hand side. I thought maybe I had some sort of infrection or something. Immediately he told me to cut my simvastatin medicine in half from the 80 mg to 40 mg and ordered blood test, which I have been getting every 90 days with no known bad results. The tightening, burning muscle soreness and joint pain has been botheering me for 6 weeks or so. I was not aware that my mecication may have been the culprit. Now I am quite certain it is the source of my pain after reading these reports.

  16. A R Reply

    I have been taking Zocor since 2003. Since that time, I have had severe muscle spasms and several incidents where every muscle in my body would contract and draw up. These episodes would last for 30-45 minutes and were VERY painful. I had uncontrollable twitching in my hands and face and I was hospitalized several times and no one could tell me what was wrong. I went to a different doctor this week and she ran several tests, one of them being a CK; my numbers were off the chart!! She explained to me that my problems were most likely a result of the Zocor. I am praying that the damage that has been done to my muscles is not permanent and that I can finally go back to a life without pain. I have had two major muscle tears that I am almost sure came from the damage caused by the use of this drug.

  17. Kristina B Reply

    I had been on Simvastatin 40mg for about 4 years. I had my CK levels checked every six months and they were showing normal. I did notice that I was getting weak, I was a pretty strong for my age. But I thought I was just getting older. My dr increased my dose from 40mg to 80mg, After 3 weeks or so on the higher dose, I started having severe muscle pain and weakness in my legs, I could barely walk up stairs. I went to the dr and my levels were off the charts, I had Rhabdomyolysis. I had to take the next week off work and drank tons of water and had my blood work done every two days until my levels were back to normal. I\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\’m a 60 year old woman. I have lost most of my muscle strength that I once had after being on this dangerous drug. I started the higher dose around late February or early March 2010. I still have concerns about what long term effects this drug has done to my body.

  18. Linda Reply

    The VA had me on simvastatin for over 3 years as a ‘preventative’ without telling me about any other side effect other than a rare risk of muscle or liver damage. Their patient information sheets included only minimal information on the side effects (not even close to what I later found on the manufacturer’s website or the Mayo Clinic’s website). While taking anywhere from 20-80 mg of simvastatin (which NEVER got my cholesterol below 200 unless I was walking 5-10 miles per day), I had problems with muscle cramps, hand tremors, depression, memory loss, increased levels of anger and hostility, greatly worsened carpal tunnel symptons, and a major loss of energy and motivation. I might have had muscle pain as well, but I was taking so much aspirin to live with the increased carpal tunnel symptoms that it might have masked the muscle pain. I’ve come across information that leads me to believe that I may be hypothyroid (a no-no for statin use), but can’t get my doctor at the VA to schedule a complete thyroid panel. I am a low-income veteran dependent on a small disability pension supplemented by Internet sales. Can anyone give me advice on where to get testing when you don’t have much money? Also, can muscle biopsies detect muscle damage even if you have stopped taking the statin?

  19. Loraine Reply

    In 2009 my doctor put me on 80mg of simvastatin, I had terrible abdominal cramping and was sick for the month that I took the medication. I stopped taking the medication and most of the symptoms disappeared, with the exception that my bowels no longer were working in a normal manner. I was having discomfort on each movement and as time went on, the discomfort became pain. I went to the ER at 4am to determine why I was in so much pain. A tumor the size of a naval orange was found. This was appoximately six to nine months after taking simvastatin. The tumor was not cancerous but it took doctors the 8 days I was in hospital to determine what the tumor was. They determined that a diverticulae had burst and when healing created the tumor??????? It is my contention that the simvastatin is what caused this issue.
    I still have issues with the muscles in my digestive system and must take medications to be able to have normal bowel movements.

  20. Coly Reply

    This class of drugs has helped many pelpoe. Medications are meant to enhance the benefits of diet and exercise, not to substitute for it. When used in the appropriate circumstances, it helps pelpoe. Goals for cholesterol were set for different circumstances and studies have shown the benefit of reaching these goals. For example, pelpoe with diabetes will have a 30% reduction in the incidence of heart attacks over 10 years when this or other drugs in this class (statins) are prescribed. Everybody should do the best they can with diet, and be open to discussion with their health care provider if they are unable to reach the established goals.

  21. k.vincent Reply

    My health bin very good never any problems till the put me on 80 mg simvastatin ,my kidney are damage it is sad that no body is telling you the full truth, And I thing this is a big crime to hurt you’r Body and the do’nt care , the belong in Prison

  22. Faye Reply

    Lawyers say they can’t help. I don’t know why. Simvastatin 80 mg has destroyed my body and my quality of life. I can’t get down play with my 6 month old grandson.or any of my 8 grand kids. I can’t WALK because of irreversible muscle damage-degenerative muscle fiber-respiratory-cramps-stiffness and PAIN 24/7. Been everywhere even mayo clinic and no one can reverse the damage they say I have. THIS is NOT getting OLD STUFF

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