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    Old 10-29-2004, 01:05 PM   #1
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    Crestor Warning

    WASHINGTON - Twenty-nine patients who took AstraZeneca's cholesterol drug Crestor have developed kidney damage, a consumer group said on Friday as it called again for a ban on the medicine.

    The rate of reported kidney problems is about 75 times higher with Crestor than with all other drugs in the same class combined, consumer group Public Citizen said. According to its analysis, there have been 6.4 reports of acute kidney failure or kidney damage for every 1 million Crestor prescriptions filled.

    “It becomes clearer by the day that this drug is uniquely toxic without offering any unique benefit, and that it must be removed from the market,” Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, wrote in a letter to the Food and Drug Administration.

     
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    Old 10-29-2004, 06:10 PM   #2
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    Re: Crestor Warning

    Emily Denney, a spokesperson for drugmaker AstraZeneca, responded that the company keeps close watch of safety reports for the drug and "we feel ever more confident with Crestor."


    She said a company analysis of FDA data indicated that, compared to other statins, Crestor was about average for kidney failure as a percentage of side effects.


    Data provided by AstraZeneca indicated that kidney failure made up 3.5 percent of adverse events for Crestor — known by the generic name rosuvastatin — compared to 5.7 percent for lovastatin, 4.0 percent for simvastatin and fluvastatin, 3.0 percent for pravastatin and 2.2 percent for atorvastatin.
    There was no immediate response to Wolfe's letter from the FDA.

     
    Old 10-29-2004, 06:31 PM   #3
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    Re: Crestor Warning

    Quote:
    Prevelance of Kidney failure discussion: More than 200,000 people in the U.S. suffer from kidney failure. As of April 2001, there are 48,639 people in the U.S. waiting for a kidney transplant.
    So the prevalence of kidney failure (I presume thats the WORST kind of damage)WITHOUT Crestor is relatively huge. If the U.S. population is 300 million or thereabouts we are talking about a condition that affects nearly 700 people of every million.
    The small number (6.4/million) for Crestor prescriptions would very likely fall though the cracks of statistical insignificance.

    I guess we'll have to wait for the FDA or a Federal court to rule on Public Citizens argument. I think they'll get nowhere.

     
    Old 10-29-2004, 06:38 PM   #4
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    Re: Crestor Warning

    From the Public Citizen Letter:

    "Crestor: There have been 29 reported cases of acute renal failure or renal insufficiency (18 cases of failure and 11 cases of renal insufficiency) out of 4.5 million prescriptions filled between the first time the drug was marketed in the U.S. – September 2003 – and the end of August 2004. This is a rate of 6.4 reports of acute renal failure or renal insufficiency per million prescriptions filled.

    All other statins (Lipitor, Zocor, Lescol, Pravachol and Me****r, including other versions of lovastatin): There have been 27 cases of acute renal failure or renal insufficiency reported from January 1, 2001, through September 30, 2003, out of 316 million prescriptions filled for these drugs during this interval. This is a rate of 0.085 cases reported per million prescriptions filled. The highest rate for any of these other statins was for Zocor, which had a rate of 0.26 cases per million prescriptions filled.

    Thus, the rate of reports of acute renal failure or renal insufficiency for Crestor is 6.4/.085, or 75 times higher than that of all of the other statins combined. In comparison to Zocor, the rate of reports of acute renal failure or renal insufficiency for Crestor is 6.4/.26, or 25 times higher than that of Zocor."

    >>>>The basis of Crestor was only 4.5 million, while the collective basis of the others was 316 million..or 70 TIMES the size (in this case # of Rx filled)! They didn't state the Zocor alone basis, but it's definitely MUCH larger than the Crestor's 4.5 million..probably 100 million plus. The point here, is that STATISTICALLY you need comparable population size (ie, # of Rx filled), since the LARGER the size, the more things tend to smooth out. This is a fairly RARE phenomenon and they made the mistake of EXTRAPOLATING results in a relatively SMALL population in order to compare it to results in a vastly larger one. Example: Would you compare the results of a study using TEN SUBJECTS to one that used 700?

    Last edited by rahod; 10-29-2004 at 06:49 PM.

     
    Old 10-29-2004, 07:21 PM   #5
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    Re: Crestor Warning

    Any damage to kidneys is unacceptable . You try to lower your cholesterol then suddenly you are looking for a new kidney , there is a good choice for you .
    I think statins are all dangerous , anything that messes around with your liver in a unnatural way is dangerous and more problems will pop up as time goes along .

     
    Old 10-29-2004, 09:02 PM   #6
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    Re: Crestor Warning

    Amen. amen. amen. i totally agree. Right now im trying artichoke extract.

     
    Old 10-29-2004, 11:07 PM   #7
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    Re: Crestor Warning

    Quote:
    Originally Posted by vipergg22
    Any damage to kidneys is unacceptable . You try to lower your cholesterol then suddenly you are looking for a new kidney , there is a good choice for you .
    I think statins are all dangerous , anything that messes around with your liver in a unnatural way is dangerous and more problems will pop up as time goes along .
    PERSPECTIVE......the incidence of Kidney damage is miniscule....in fact, even if you choose to accept the 29 cases out of 4.5 million Rxs filled..that is no more than one would expect in the general popuplation. Get a GRIP!

     
    Old 10-30-2004, 04:49 AM   #8
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    Re: Crestor Warning

    The incidence of damage from taking ASPIRIN and its sister NSAIDS is orders of magnitude higher than this triflingly low incidence with Crestor, if indeed these risk numbers even report statistically significant cause and effect (which is dubious.)
    The foolish doctor Wolfe who called Crestor "uniquely toxic" is UNIQUELY uninformed about risk/benefit ratioand he will be ignored by the FDA for a good reason...he's not presenting convincing evidence.

     
    Old 10-30-2004, 07:07 AM   #9
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    Re: Crestor Warning

    I still say it's not worth taking the chance. I was prescribed a cholesterol-lowering drug and refused to take it. I don't like having to rely on drugs every day for ANYTHING, especially a drug that messes with liver function. I realize that because of genetics not everyone can get their cholesterol down with diet and exercise alone. And I feel for those people because they have no choice than to take the drugs or live with high cholesterol. But even in that case, I think I'd rather just live with the high cholesterol.

    These are just my opinions, however, and not meant to insinuate otherwise beliefs or insult anyones intelligence.

     
    Old 10-30-2004, 01:27 PM   #10
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    Re: Crestor Warning

    LV,

    Everybody has the right and the self-owed duty to make what he considers an informed choice. You have made yours.

     
    Old 10-30-2004, 03:53 PM   #11
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    Re: Crestor Warning

    Quote:
    Originally Posted by rahod
    PERSPECTIVE......the incidence of Kidney damage is miniscule....in fact, even if you choose to accept the 29 cases out of 4.5 million Rxs filled..that is no more than one would expect in the general popuplation. Get a GRIP!
    I think you need to get a grip . You are ignoring the thousands upon thousands that statins in general have permanently harmed . I am one them , I have permanent nerve damage in both feet and basically have no feeling left in either , I am 47 so I have to put up with this the rest of my life . Is it a small percentage , maybe but I also believe it is a lot higher than the drug companies will ever admit. You also have a percentage where the doctors also tell the patients that it can't be the drugs which is exactly what happened to myself .

     
    Old 10-30-2004, 06:06 PM   #12
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    Re: Crestor Warning

    Quote:
    Originally Posted by zip2play
    LV,

    Everybody has the right and the self-owed duty to make what he considers an informed choice. You have made yours.
    Yes I have

     
    Old 11-03-2004, 11:16 PM   #13
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    Re: Crestor Warning

    As a footnote to the level-headed thoughts from rahod and zip2play about the rarity of Crestor-induced acute renal failure, I'd like to point out that this condition -- while something to take quite seriously -- doesn't usually cause permanent damge if treated. Quoting from the National Institutes of Health:

    "Although acute renal failure is potentially life-threatening and may require intensive treatment, it usually reverses within several weeks to a few months after the underlying cause has been treated." And it's caused by Crestor (as well as some very-well-established drugs and herbs and supplements like chromium, aloe and black cohash) *rarely*.

    Sidney Wolfe is basically raising a ruckus because he couldn't convince the FDA to refuse Crestor approval. He was probably trying to earn some "attaboys" from Ralph Nader, founder of Public Citizen, by showing Ralphie that he could get a drug banned. Fyi, Wolfe and Public Citizen say there is also no reason for anyone to take Lipitor. Also fyi, I am by no means anti-supplement or anti-herbs -- I use both.

     
    Old 11-11-2004, 03:32 PM   #14
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    Re: Crestor Warning

    Incidence of side effects with statins is no more than what happens if you don't take a statin.
    What do you blame for the incidence of 50% of all American males having heart attacks at some point in their lifetime?
    Crestor safety should have come into question at the One million Rx point, it's at 10 million now. Sidney Wolfe is a dolt, no one in DC respects him.

     
    Old 11-11-2004, 03:34 PM   #15
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    Re: Crestor Warning

    Look at the ad at the top of this page and ask yourself, Do lawsuits rule our country?

     
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