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Thread: FDA issues warning for high doses of Zocor

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    Default FDA issues warning for high doses of Zocor

    Fri, Mar 19 2010

    WASHINGTON (Reuters) - Patients on the highest approved dose of the cholesterol-lowering drug Zocor may be at increased risk of muscle injury, U.S. regulators warned on Friday.
    Made by Merck & Co and sold under the brand name Zocor, simvastatin is also is sold in combination with ezetimibe as Vytorin, and in combination with niacin as Abbott Laboratories Simcor, the U.S. Food and Drug Administration said in a statement. Simvastatin also is available as a single-ingredient generic medication.
    The FDA said its review of simvastatin is part of an ongoing effort to evaluate the risk of statin-associated muscle injury.
    "Although muscle injury ... is a known side effect with all statins, the warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of this drug," the agency said in a statement.
    The warning follows an FDA review of new information on the risk of muscle injury from clinical trials, studies, adverse event reports and prescription use data, the FDA said.
    The FDA said it was also reviewing data from a clinical trial which studied cardiovascular disease in patients prescribed 80 milligrams of simvastatin compared to those on 20 milligrams.
    Rhabdomyolysis is the most serious form of muscle disease and can lead to severe kidney damage, kidney failure, and sometimes death, the agency said.
    "It's important for patients and healthcare professionals to consider all the potential risks and known benefits of any drug before deciding on any one therapy or dose of therapy," said Dr. Eric Colman, deputy director of FDA's Division of Metabolism and Endocrinology Products.
    (Editing by Richard Chang)

    http://tinyurl.com/ye4yb2q

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    Veteran Member mellowsong's Avatar
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    Default Re: FDA issues warning for high doses of Zocor

    I developed muscle injury on only 10mg/day of Zocor. Redeveloped when switched to Mevacor. Believe me those were in my unenlightened days when I did everything the doc suggested. I think the harm is way understated.

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    Default Re: FDA issues warning for high doses of Zocor

    Mello, I agree with you. A have a very few friends who were on statins, who trust me, who took my advice and d/c'ed them, feel much better.

    I have other friends and family members who tell me, I pay my doctor for this advice. He went to med school, you didn't.

    :: deep sigh ::

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    Default The hidden deadly danger in your statin drug

    e-letter from "Healthier Talk" <healthiertalk@healthiertalk.com>
    April 19, 2010

    The FDA’s blind eye has at long last been opened...if only briefly. They’ve finally admitted that statins aren’t just causing a little minor muscle weakness or pain. They’re now cautioning that they can literally kill you!

    The strongly worded news release is targeted at Zocor users, saying that a possible side effect of the drug “...can lead to severe kidney damage, kidney failure, and sometimes death.”

    Myopathy, a muscular disease that causes a weakening of muscle fibers, is a known serious side effect of statin drugs. But now the FDA is saying that Zocor may increase your risk of getting the most severe form of the muscle destroying disease known as rhabdomyolysis.

    Rhabdomylosis causes muscle fibers to actually break down and enter into your bloodstream. This can lead to kidney damage and eventually, in the worst cases, even death. Because the symptoms of rhabdomylsis vary and can mimic other things many people are unaware that they even have it.

    If you’re on Zocor—or other combination-drugs that include Zocor in the mix like Vytorin or Simcor—and have any of the following symptoms you should contact your doctor immediately:
    • a change in the color of your urine (red, dark, or cola colored)
    • muscle tenderness
    • stiffness or aching in your muscles
    • muscle cramping
    • fatigue
    • general weakness
    • seizures
    • unexpected weight gain
    Don’t be surprised if this increased scrutiny by the FDA means that Zocor might eventually be joining the list of 7 other statins already pulled from the market. The last to join the dubious-list-of-distinction was Baycol, yanked from the market back in 2001 for…yes you guessed it... muscle damage.

    It’s time they ban these dangerous statins altogether! Now...before more innocent people and children (yes children, they’re testing them as young as 8 these days!) die.

    For some healthy alternatives see Lower your cholesterol without statins!
    Taking bets on when the list of 7 becomes 8,

    Alice Wessendorf

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    Veteran Member mellowsong's Avatar
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    Default Re: FDA issues warning for high doses of Zocor

    When I was on statins (I honestly don't remember which ones) they were absolutely certain I had MS and shocked when the MRI showed no plaque in my brain. Then, my doctor happened to read an article about a case of rhabdomyalosis definitely related to statins, called me, told me to stop immediately and come over to his office and get some lab work. Well, the lab work showed I had impending kidney failure. The test that shows muscle damage was through the roof. Within a month of stopping the statins, most symptoms were gone. I have never regained any muscle strength though and it's been over 10 years since this happened.

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