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Crestor death

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General fitness, health and nutrition
Published
4 March 2004
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7 March 2004
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Zee
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  1. Fall 2003 citizen.orgrelease.cfm "Sept. 16, 2003

    Public Citizen Warns Against New Statin Drug Crestor Cholesterol Drug Potentially More Dangerous
    Than Baycol; FDA Should Not Have Allowed on Market

    Today:

    (AP) A 39-year-old woman has died of a muscle-destroying condition linked to the controversial new
    anti-cholesterol drug Crestor, a consumer group said Thursday, citing 16 cases of serious side
    effects in urging a ban of the drug.

    The consumer advocacy group Public Citizen, in a petition filed with the Food and Drug
    Administration, is seeking a ban on the drug.

    Crestor is in the popular family of cholesterol-lowering drugs called statins. It won approval FDA
    in August, after a delay because of safety concerns: Seven cases of the potentially fatal, muscle-
    destroying condition called rhabdomyolysis occurred during studies involving patients on an 80-
    milligram dose.

    For that rare condition to pop up in clinical trials was unusual and particularly worrisome since
    another statin, Baycol, had been pulled off the market in 2001, linked to dozens of rhabdomyolysis-
    caused deaths worldwide.

    In studies, Crestor also was linked to some cases of kidney abnormalities not seen with
    other statins.

    Still, the FDA ultimately decided to approve Crestor, saying it appeared to be slightly more potent
    than other statins and thus may be important for some patients. To lower the risk of side effects,
    FDA recommended starting doses of 5 mg. to 10 mg, and said patients should never exceed 40 mg.

    But records from the FDA and health agencies in Canada and Britain show life-threatening side
    effects occur even at those lower doses, said Dr. Sidney Wolfe of Public Citizen.

    Among the records:

    Seven patients with rhabdomyolysis, including the 39-year-old American who died after using a 20-mg
    dose, and a second death from an unspecified country.

    Four patients with acute kidney failure, including a 79-year-old U.S. man who died.

    Five additional patients with less severe kidney damage.

    Also, among six patients, Crestor interacted dangerously with the blood-thinner Coumadin, commonly
    used by heart-disease patients. One had a hemorrhage, Wolfe said.

    Crestor maker AstraZeneca wouldn't comment on the deaths or other serious side effects except to say
    "the safety profile is totally comparable" to what pre-marketing studies had predicted, said
    spokesman Gary Bruell.

    "We're very pleased with the performance of the drug thus far," he said, noting that 1 million
    patients worldwide have tried Crestor, including 600,000 in the United States. The company is about
    to begin major television advertising for the drug.

    But Wolfe contended that Crestor "has no unique advantage, but some unique risks" over other
    statins. He told the FDA there is growing concern about the drug, citing two major U.S. insurers who
    refuse to pay for it because of the muscle risk and a recent recommendation against use by Sweden's
    drug advisers.

    ©MMIV, The Associated Press. All Rights Reserved. This material may not be published, broadcast,
    rewritten, or redistributed.

  2. (Zee) said:

    Fall 2003 citizen.orgrelease.cfm "Sept. 16, 2003

    Public Citizen Warns Against New Statin Drug Crestor Cholesterol Drug Potentially More Dangerous
    Than Baycol; FDA Should Not Have Allowed on Market

    Today:

    from BMJ: November 5 2003

    "As a GP practicing in the UK, it would have been difficult to avoid the marketing hype of "Crestor"
    and have personally attended a number of educational seminars conducted by local Cardiologists and
    Chemical Pathologists advocating the use of this statin. Comparison data against atorvastatin was
    impressive and I began using it in my clinical practice.

    I have been very impressed with the resulting favourable lipid profiles of my patients and have
    gained target lipid levels without exception at the starting 10mg dose. In addition, patients
    previously treated suboptimally with higher dose atorvastatin or simvastatin 40mg, have enjoyed
    similar normalisation of their lipid profiles. I now use rosuvastatin as my first choice statin, and
    have encountered no adverse reactions or liver function test derangements or
    haematuria/proteinuria."

    Dr Grant Dex, GP Principal Nottingham, UK NG9 6AH

  3. I started on 10mg Crestor last week. I have borerline high
    LDL of 132mg/dl and a 3.95 ratio LDL/HDL. I have been off
    Lipitor for a year to see what would happen as far as my
    levels go and they returned to these levels, about what they
    were before I started on Lipitor.

    I am 52, have borderline high blood pressure and take
    Altace 10mg for that as well. I am sitting on the fence as
    far has whether or not I am high risk or not and have
    decided with my physicians to be conservative and follow
    high risk protocol. The reason for this is that after a
    cranial CAT scan done about 3 years ago (headaches) I was
    surprised to be told that the scan showed I may have
    sufered from a stroke (more than 1 year old). I had no
    symptoms. Headaches were not resulting from this though,
    probably type of migrane.

    After a million tests and being followed by a neurologist,
    an MRI determined that the space (from the ischemia shown on
    the CAT) was something called a Virchow-Robin's Space and
    was not considered to be a stroke, just a congenital brain
    formation that shows as a space but is not a threat.

    But the neurologist said that I should be treated more
    carefully, in case the MRI diagnosis was wrong and the
    CAT scan was right, in other words, probably not a
    stroke, but maybe.

    Hence my treatment of borderline hypertension and lipids.

    My family doctor suggested Crestor. He takes it himself and
    he's a super fit guy, has genetic heart disease in the
    family and very high cholesterol levels.

    I really wanted 5mg since my LDL was not that high and
    my HDL is not bad 53mg/dl, but here in Canada Crestor
    only comes in 10mg as the lowest dose whereas in the US
    it is 5mg.

    Just thought I would share.

  4. "George" <[email hidden]> wrote in message
    "]news:[email hidden]...

    Quoted message said:

    I started on 10mg Crestor last week. I have borerline high
    LDL of 132mg/dl and a 3.95 ratio LDL/HDL. I have been off
    Lipitor for a year to see what would happen as far as my
    levels go and they returned to these levels, about what
    they were before I started on Lipitor.

    I am 52, have borderline high blood pressure and take
    Altace 10mg for that as well. I am sitting on the fence as
    far has whether or not I am high risk or not and have
    decided with my physicians to be conservative and follow
    high risk protocol. The reason for this is that after a
    cranial CAT scan done about 3 years ago (headaches) I was
    surprised to be told that the scan showed I may have
    sufered from a stroke (more than 1 year old). I had no
    symptoms. Headaches were not resulting from this though,
    probably type of migrane.

    After a million tests and being followed by a neurologist,
    an MRI determined that the space (from the ischemia shown
    on the CAT) was something called a Virchow-Robin's Space
    and was not considered to be a stroke, just a congenital
    brain formation that shows as a space but is not a threat.

    But the neurologist said that I should be treated more
    carefully, in case the MRI diagnosis was wrong and the
    CAT scan was right, in other words, probably not a
    stroke, but maybe.

    Hence my treatment of borderline hypertension and lipids.

    My family doctor suggested Crestor. He takes it himself
    and he's a super fit guy, has genetic heart disease in the
    family and very high cholesterol levels.

    I really wanted 5mg since my LDL was not that high and
    my HDL is not bad 53mg/dl, but here in Canada Crestor
    only comes in 10mg as the lowest dose whereas in the US
    it is 5mg.

    Just thought I would share.

    I assume you have tried diet and exercise. Exercise, in
    particular, helped me a lot.

    I routinely cut Lipitor pills in half with a pill cutter. If
    it works, this would not only give you the amount you want
    but save you money. With Lipitor they are not scored so you
    may end up with a little bit more or less in one part, but
    with this drug I don't think that matters much - the little
    bit you miss on one day you make up on the next. It did not
    take much practice to be able to do this reasonably.

    Bill

  5. Yes I thought about cutting the pill. It's Crestor not
    Lipitor. I was on Lipitor 2 years ago. Crestor is not scored
    either. Where do you get a pill cutter and what is it?

    My sister who is a doctor said not all pills can be cut,
    because it alters their efficacy. Not all pills are like
    this. Was also thinking about taking the dose every other
    day. Crestor and Lipitor have rtelatively long half lives
    compared to Zocor and others.

    My family doctor said to go 3 months on Crestor, get tested,
    and then try playing around with dosages.

    Fitness is not an issue with me. Weight is negligable, maybe
    10 pounds at best, however I have maintained the weight I am
    now for many years. In summer I drop maybe 5 pounds usually.

    My cardiologist has written my family doctor saying that
    even if my LDL was normal or below he would want me on a
    Statin regardless by the time I am 55. Again this is because
    of the uncertainty surrounding my CAT/MRI.

  6. "George" <[email hidden]> wrote in message
    "]news:[email hidden]...

    Quoted message said:

    Yes I thought about cutting the pill. It's Crestor
    not Lipitor. I was on Lipitor 2 years ago. Crestor is
    not scored either. Where do you get a pill cutter and
    what is it?

    My sister who is a doctor said not all pills can be cut,
    because it alters their efficacy. Not all pills are like
    this. Was also thinking about taking the dose every other
    day. Crestor and Lipitor have rtelatively long half lives
    compared to Zocor and others.

    My family doctor said to go 3 months on Crestor, get
    tested, and then try playing around with dosages.

    Fitness is not an issue with me. Weight is negligable,
    maybe 10 pounds at best, however I have maintained the
    weight I am now for many years. In summer I drop maybe 5
    pounds usually.

    My cardiologist has written my family doctor saying that
    even if my LDL was normal or below he would want me on a
    Statin regardless by the time I am 55. Again this is
    because of the uncertainty surrounding my CAT/MRI.

    If you have started down the 3 month road you might want to
    just continue that rather than going back to the Dr. and
    develop a new plan. Your sister is right about some pills -
    for the most part those that come in capsules, those that
    are time released, or those in which the exact dosage is
    important should not be cut. For Lipitor, I don't think it
    is a problem. Ask your Dr. about Crestor. The every other
    day thing may work too.

    I got my pill cutter at the local drug store for about $4.
    It is sort of a plastic half sphere with a flat top and a
    strong razor blade in the middle. You put the pill on the
    table, line up the razor blade so it is across the middle,
    and push down. The pill usually breaks into about equal
    parts and the plastic keeps things from flying. I've also
    seen others with a lever and a cutting part that looks like
    a guillotine.

    Bill

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