Legal News Watch - Consumer Rights Blog

Consumer Group Warns Against New Cholesterol Drug Crestor

September 17th, 2003 · 35 Comments

Public Citizen, a consumer advocacy group, says new cholesterol drug Crestor from AstraZeneca may cause kidney damage and failure, as well as muscle destruction (rhabdomyolysis). The U.S. Food and Drug Administration approved Crestor on August 13 and it is just now becoming available by prescription.

“It was irresponsible of the FDA to approve this drug without requiring routine urine testing for protein and blood to monitor for the early signs of kidney damage, ” said Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group. “This drug is already showing signs that it is too dangerous for people to take, and it is only a matter of time, after ‘enough’ people have been injured or killed, that it will have to be pulled from the market.”

In studies before its approval, seven people were struck by cases of rhabdomyolysis, an adverse reaction involving the destruction of muscle tissue that can lead to kidney failure, according to the consumer group.

Baycol, another statin, was removed from the market in the fall of 2001 after at least 31 reports of fatal rhabdomyolysis.

In addition to the risks of kidney damage, Public Citizen warns patients against Crestor because it has not been shown to reduce the risk of heart attacks and strokes, which is a benefit of lower cholesterol levels.

(via Public Citizen)

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Tags: Crestor

35 responses so far ↓

  • TLA // Oct 9, 2003 at 5:58 pm

    I don’t understand how people get away with spreading this type of information. In reviewing the web sites, including the FDA and the Package Insert as well as multiple clinicals, there is nothing to support these claims. In review, not a single drug except oncology has mortality data available. Yet all physicians realize that all statins reduce the relative risk of heart attacks and stroke by reducing LDL and improving HDL. This is a class effect. Stop publishing these types of misinformation. The public deserves it.

  • ASW // Oct 26, 2003 at 5:38 pm

    In reference to TLA’s comments, in Crestor clinical trials submitted to the FDA 8 cases of rhabdomyolysis occured. By comparison, no cases of rhabdomyolysis occurred during development for any other statin. In addition, the FDA’s Endocrinologic & Metabolic Drugs Advisory Committee recommended that renal function monitoring be required for patients taking Crestor 40mg. To imply that Crestor is as safe as the other statins is clearly not true especially when compared against the tremendous accumulation of safety data with many of the other statins. Finally, Crestor was recently added to the worstpills list maintained by Public Citizen due to concerns about the safety of Crestor and can be accessed at http://www.worstpills.org

  • BD // Oct 30, 2003 at 6:55 pm

    How do you people get away with this. You act like Crestor is the only Statin that has protein. All of the major statins have protein. If the FDA was worried about Kindney damage there would have been a severe restriction put in the PI, and for you to say that Crestor is the only statin thats had Rabdo during clinical testing is an outright lie. What don’t you people just admit you hold a ton of pfizer stock, or at least are paid for you comments. You all talk about the safety data behind Lipitor, tell that to the patients recently featured in the Novemeber issue of Smart Money.

  • CA // Nov 18, 2003 at 3:19 pm

    Obviously ASW is unaware of all his facts and didn’t speak with the lead clinicians in depth about what was found in the studies. The FDA commitee unanimously approved CRESTOR. See the transcript. I believe Dr. Sydney Wolf was asked pointed questions that countered his attempt to discredit data which he obviously misunderstood. Crestor will set the standard and will save lives because it reduces LDL better than competitors and has a safety profile second to none. The route of metabolizm and chemical property make it the leader in clinicians minds. The data is tight and confident. Public Citizen truly needs to support advances in medicine and not hinder them.

  • EL // Nov 28, 2003 at 12:03 pm

    TLA and CA,

    did you know that

    “During clinical trials rhabdomyolisis turned up in patients receiving the 80 milligram pills of Crestor. Astrazeneca originally sought FDA approval for pills up to 80 milligrams and later voluntarily withdrew and resubmitted its application for pills up to 40 milligrams. The FDA approved the 40-milligram pills however warned against 40-milligram pills as the starting dosage.”

    And also that Wellpoint the second largest private health insurer is not reimbursing for this drug because of safety concerns.

  • MB // Nov 29, 2003 at 7:33 pm

    BD…You should learn what you are talking about. Crestor is the only statin in pre-FDA approval trials that had any cases of Rhabdo. Not even Baycol had cases of rhabdo until it started killing 42 people. CA…Crestor does not have a safety profile second to none. It had one case of rhabdo at the 10mg dose and had proteinuria and hematuria at the 40mg dose. These are not class effects. The National Kidney Foundation just supported that Lipitor does need any dose reductions in patients with any kind of renal failure whereas Crestor is severely restricted. You should learn what you are talking about before you start typing.

  • MB // Nov 29, 2003 at 7:37 pm

    I meant that Lipitor does NOT need dose reductions with severe renal patients.

  • Belma Caramanna // Dec 16, 2003 at 10:37 am

    I was in the Crestor Drug study starting in 1999. In 2000 I was told to take a double dose of the 40mg crestor {80mg}. Within a short time never having a heart problem I developed a very serious arythimia. I immediately had a catherization that showed damage to the heart muscle. Following that I had an Ablation done. That corrected the problem for almost three years and am now going through the same thing. The study group assured me Astra Zeneca would help with my medical bills $10,000 for the catherization alone. I was fully covered when the ablation was done. Astra Zeneca refused any help with the first surgery and had no desire to investigate this at all. I truly feel that the 80mg was what caused permanent muscle damage to my heart. There is so far noone who will help with this matter.

  • BAL // Dec 30, 2003 at 5:39 am

    Ok- the new cholesterol lowering drug Crestor obviously has concerns that many people are weary of. Lipitor itself has had many issues of myopathy (muscle weakness) at higher doses taht so many people overlook. Let’s not forget that only 5% of Americans suffer from EXTREMELY HIGH Cholesterol. The point I’m trying to make is that there has been so much hype about Lipitor over the years and NOW Crestor- both being able to bring LDL levels down dramatically- however, this is ONLY necessary in 5% of the treatment population. Nobody ever talks about a statin that can get patients to target goal in the other 95% of the poulation- a drug that is ALSO metabolized in the same easy rout as the new Crestor- and this statin I speak of IS, and I say with fact, IS the onyl statin that HAS NEVER had a reported case of rhabdomyolosis- IT ALSO has NO restrictions with the renally impaired- this drug is LESCOL XL 80 mg- the only 80 mg statin that can be TOLERATED where other 80 mg’s can’t. My mother’s been on this drug for two years and she’s doing great.

  • Kenetra // Feb 24, 2004 at 4:04 pm

    I personally believe in the body healing itself through nature and it’s own inherent ability. I have been a vegetarian for the last 3-4 years and have dropped my cholesterol level but just a couple of months ago I found out about an all natural alternative to Lipitor and Crestor with no known side effects and it’s a lot cheaper than drugs without the side effects, called Phytomega. Do some research on it. Best regards to all.

  • Stuart Hutton // Feb 29, 2004 at 2:10 pm

    I guess I must be the odd one out here I was on Baycol for almost a year in 2001 with great results and no side effects. I then had to take lipitor, terrible, then zocor equally bad and then pravachol bad but limited effect on my lipids. I have now been on crestor 10mg for a year and it is wonderful. My ldl is down to 73, my total down to 110 and little or no side effects. For me the issue is that crestor would appear to be effective with relatively low doseage.

    Note the side effects that I had with lipitor, zocor and pravachol included, muscle soreness, headaches, tachycardia and dizziness, now almost nothing with crestor. I also take about 100mg of coQ10 on a daoly basi with a natural source vitamin e, seems to work for me.

    I am assuming crestor will remain on the market as many individuals like me are benefiting from it with no side effects.

  • MD // Mar 5, 2004 at 3:59 pm

    you all need to go back to pharma school. Lets look at the real issues. There have been over 30 deaths associated with lipator, Zocor, and even prava, The most tolerated statin. What would happen if 160 mg lipator was used? The same thing that happened to Baycol. Any statin used at high doses increases side effects and risk. Truth be told, Crestor looks the most like Prava ( dual elimination route, hydrophilic, minimally metabolized (>10%) doesnt use the 3A4 pathway. Do you all really think the FDA wants another Baycol out there after the black eye they got? We should be thankful to Baycol. Why? Crestor was the most extensively studied and scrutinized ever. More pats in preclincial trials for longer periods than Lipator, Zocor and Prava combined. This is the safest of the safe. Will pats have problems with Crestor? yes just like they do on other statins. HMG CoA Reductase inhibitors all have the potential but all are very similar in risk and side effect profiles. Pfizer is scared. They’re losing market share to Crestor, Levitra, Cialis, and other drugs. They’ll do anything including getting in the bed with groups like public citizen (quackery) to save their hide. They paid 60 Billion for Warner-Lambert- it wasn’t for the Chicklets and Listerine) if you catch my drift. They made 9 Billion on Lipator 2003. Who’s got the most to lose?

  • BJ // Mar 6, 2004 at 1:56 pm

    This type of reporting screams of bias. It is unclear to me what function (consumer advocacy?)that Public Citizen serves other than to spread misinformation about products that have helped hundreds of thousands live healthier, more productive lives. Sydney Wolf is no doubt a cook who serves to get rich and use these forms of media to try and do harm to the corporations that he has not allied with. Crestor is a superb drug with a solid track record of safety. There were more than 3 times as many patients involved in the pre-approval trials for Crestor than with any other statin. This included head-to-head trials(STELLAR)in which incidence of adverse events were similiar with allstatins studied. Many physicians have commented to me on the ability of Crestor to help them better manage all lipid measures in dyslipidemia patients that had previously failed to meet their NCEP ATP III treatment goals. These physicians are particularly impressed with how well Crestor is tolerated as compared to many patients previous statin regemins. Plus they appreciate the fact that they are able to get significantly more patients to goal at the low 10mg starting dose with Crestor; not the case when you consider clinical trial data with other statins. Please do the public a favor and quit advertising yourself, your group or whatever you “think” you are as a public advocacy group. Your group is nothing more than a propagator of lies.

  • Anthony Nicol // Mar 15, 2004 at 9:34 pm

    get an eye on the link below, some from FDA, others from DC, not much from drugstores. The lessen arm should be the reason… for stoping it’s use.

    http://www.mywebsearch.com/jsp/GGweb.jsp?searchfor=fda+statins+warning&fr=10&st=bar&ptnrS=ZSzeb028

    with all that bad stuff on statins, i’m saying never to this cholesterol lowering. i want to stay alive. i dont have the right to risk any part of myself, to feed money to these drugs makers. do you think mc donald invested money in pharmaceuticals, so it can make money both ways?

  • ND // Mar 27, 2004 at 2:23 pm

    It seems to me that people forget how pharmaceutical drugs are not the only method, and by far not the safest method, to reduce cholesterol levels. Look at the dietary and epidemiological studies that show higher cholesterol and MI rates in northern European countries and North America va southern European countries and Asian countries like Japan (and the only reason such rates are increasing in those countries is because they are adopting the American way of life!). Perhaps the fact that more than 64% of the United States is OBESE says that we need more than just yet another pharmaceutical to control our risk of heart disease. Oops! I always forget, if people ate better and exercised more there wouldn’t be as big a need for physicians and pharmaceutical companies in cholesterol and heart disease risk reduction…

    Take a look at the standard medical school curriculum. Where are the courses in nutrition? Talk to the average physician or medical student - they don’t have time to teach their patients about eating better or exercising, if they know anything about it at all. Look at the average causes of death for physicians; one of the unhealthiest professions in this country. THEN talk about ‘misinformation’ re statin drugs. Misinformation is telling your patient his cholesterol level is too high and cranking out a prescription, instead of talking to him about the medication’s numerous (not just rhabdomyolysis) risks, and steering him in the direction of a healthier lifestyle that will not only reduce cholesterol levels but also reduce his risk of a multitude of other diseases. There is a time and a place for pharmaceuticals. Statin drugs are NOT the be-all and end-all in cholesterol reduction. Pull the cheeseburger out of your mouths and drag your butts away from the computer, then you’ll realize that only a small percentage of Americans REALLY need statin drugs.

  • April // Apr 3, 2004 at 6:50 pm

    Hi I was wondering if more people recommend Crestor or if more people advise against it. My grandmother called and said they are wanting to put my grandfather on Crestor. She wanted me to look up some information on the drug and its side effects. I see the conversation going both ways. How do you decide to be put on a medication that has so much controversy and has caused many problems and even death? My grandfather has had heart surgery and other problems. How does he know if this can hurt him or not. I love my grandfather very much and I would just like some honest opinions. I want him to be here to watch my daughter grow. Please feel free to e-mail me and give your opinion, I just want him to be healthy and make the right decision for a healthy life. Thank You

    aprillynn82@zoominternet.net

  • BD // Apr 6, 2004 at 1:49 pm

    If you people listen to MB you will be denying yourself one of the best drugs in the class at lowing LDL-C. What MB is not telling you is the reason none of the other drugs in the class including Lipitor had no reported cases of Rabdo or deaths prior to launch is because prior to Baycol it wasn’t looked at. Lipitor came to market with 1,300 people studied on it. Crestor had over 10,000. Had Pfizer studied the same amount of patients their numbers would have been much different. Despite what MD says, all statins have protein in the urin. AstraZeneca was just the first company honest enough to report it. Let one of the older statins go for a new indication and find out how quick the FDA makes them put it in their package insert. Ask yourself why MD failed to tell you all about the thousands of patients taking Lipitor who are now having memory problems. The only thing Pfizer if protecting is a 55% market share of the statin market. Crestor is safe at approved doses, works better than Lipitor and Zocor and cost less. Thats the bottm line.

  • Overwhelmed // Apr 20, 2004 at 2:01 pm

    I am truly overwhelmed by all the conflicting information. My family has a terrible history of heart disease (father died at 46, one brother at 47, and one brother has just had his second heart bypass). My mother died at 78 of heart failure. I am 56 and have been told that I need to go on a cholesterol lowering drug. I take no medications, and am reluctant to start taking this one. My total cholesterol is 219 (LDL 152;50 HDL). And because of my family history, my cardiologist wants me to start this drug. I have never had any type of heart problem. I’m a mountain bike rider as well as a weight lifter. My stress test was “great”. I would appreciate any feedback regarding Crestor. Thanks.

  • Maricat // May 3, 2004 at 11:03 am

    If you folks are going to spew out statistical information, you would do well to cite your sources. I just read this whole page, and haven’t a clue as to who is right or wrong. If you cite your sources, people can do further research on their own. It is unwise and unethical to do anything else! I never believe anything about any study unless I can have access to that information myself. Otherwise, it’s just a rumor, or someone elses’ interpretation. If this site is legit., you will post every study that you quote.

  • judy // May 7, 2004 at 10:30 am

    trying to get this printed , also Iwas just put on it. is it safe or not

  • SJW // May 12, 2004 at 10:05 pm

    Well I just got a script For Cerstor Today From My Dr. And Since I Knew Nothing about It.. Decided To look It Up.. Now I am Really Confused .. I am Diabetic & Don’t Need Any Kind Of Kidney Problems… Guess I need To Do some More Research on It.. Thanks To all Of you tho for Your Input.

  • Carol Sutton // May 24, 2004 at 1:32 am

    Have just started taking this drug for two days, having taken statins for years, and have been experiencing an upset stomach. Is this a side effect?

  • CJP // Jun 7, 2004 at 10:22 am

    I just started Crestor 10 mg about 3 -4 weeks ago and have been having dizziness, lack of energy and memory loss. I am shocking myself at the things I can’t recall. I am a nurse and things I do every day I forget. So much so it scared me and I have discontinued this medication and am making an appointment with my doctor for a complete exam.

  • kathy // Jun 26, 2004 at 7:07 pm

    I just started taking crestor and on the news one night the news mansaid this was very dangerest and the FDA is taking it off the market. So i called my doctor and they took me off of it right away and put me on something much safer. My husband was part of the case testing for lipitor and i will tell you it is much safer then crestor. I am too young to begin problems worse then just cholestoral……muscels is not just around your bones …your heart is a muscels and i donot think you wanna lose that……think about it

  • FDNH // Jul 15, 2004 at 9:58 am

    Study after study has proven exactly one thing. The protective effect of statins are independent of LDL level and are most like due to and anti-inflammatory or anti-thrombotic effect. It is madness when they suggest “the lower the better”. In my view - the greatest danger of this madness is the depletion of COQ10 and a rise in CHF, not to mention muscular and cognitive side effects. Instead of being obsessed with your lipid numbers be obsessed with your over-all health. Big pharma won’t stop until they make patients of us all. Learn the difference between relative and absolute risk. If a drug has an RR of 1.2% vs a placebo RR of 1.6% (as in WOSCOPS) thats an impressive 25% reduction right? Wold you be as impressed if told that that translates into the odds of escaping death with treatment is 98.8% with treatment vs 98.4% without it?

  • Gary Novak // Jul 15, 2004 at 2:08 pm

    Pushing drugs such as statins enslave the public to the medical establishment, while the cause is ignored. Biochemistry theory and evidence clearly show that chlorinated water underlies the problem. Halides such as chlorine react by substitution, which means they attach to other molecules, such as artery walls. Leukocytes then see the arteries as foreign and attach to them. They continue to do what they always do, which is to remove calcium and lipids from the blood, when they are not attached to carrier molecules. Evidence is in the fact that Europeans have less of a problem, and they ozonize instead of chlorinate their drinking water. http://www.nov55.com

  • Phyllis // Aug 19, 2004 at 12:35 pm

    After having blood drawn and tested, my doctor decided that I should be taking a statin drug to lower my cholesterol. His choice of drug being 10 mg. Crestor. After taking the drug for a very short time, I had a terrible reaction to the drug. I noticed a tightness is my chest which finally became so bad that I could hardly breath. It was at this point that my husband researched the side effects of Crestor. I immediately stopped taking Crestor. I returned to the doctor. He then decided that it was most likely the Rx that was causing my wind pipe to swell, thus causing all of my life threatenng symptoms. I decided that if I can not breathe, it makes little difference what the readings are concerning my elevated cholesterol. This drug is very dangerous and to imply that it is safe is a misjustice. The FDA better step in and further their testing of not only Crestor but ALL statin drugs!

  • Max // Aug 28, 2004 at 11:44 am

    I am wondering if anyone else has experienced what I went through when I started taking Crestor - I had dizziness and my heart rate dropped significantly. I am a semi-pro athlete so excercise is a routine with me but I do not dare to keep taking this drug!

  • Mary Rose // Aug 30, 2004 at 9:19 am

    I had 2 stents put in on 8/14/2004 for blockages. No heart damage. My cholesteril readings in the hospital (non fasting) were Total C. 179. LDL 120, HDL 35 and trglycercides 90. They said my nubers were not good and the Cardio doc said Crestor was a great and new drug with no problems. ( I had been on Lipitor a few years back and had horrid tummy aches and weakness)

    Well, well. well, After taking Crestor for 3 days, 10mg. I feel awful. How can this cardio doc tell me this is a great drug with no side effects. I am so weak and so lethargic and my legs are not working. I am getting a a strictor diet as I am told my LDL had to be wayyyyy inder 100 now per new guidelines. I bet there are other statins just as bad as Crestor. I think I will investigate Cholest-off (over the counter) and see how I feel and if this will help my LDL. My total cholesterol and triglyercides are great. I wonder how than can be with a lousy LDL?

  • Pat Spanko // Sep 16, 2004 at 8:23 am

    I was taking Crestor for only approx 7weeks, having very bad arthritis I was not aware of the symtoms presenting themselves not being from my arthritis, ended up in critical condition with rhabdomyolysis, my doctors were just horrified. Now after 2 1/2 months I am still a long way from returning to any kind of a normal life, this should have never happened. Would like contact with any other victims in Canada. Thank you. 1-306-354-7719.

  • Jackie Malangone // Oct 14, 2004 at 10:33 am

    I am interested in knowing if their are any chat groups out there consisting of people who are suffering from taking Crestor.

    I started taking only 10 mg.last November and I took it for six weeks. I was fine until one night I tried to get up out of bed to go to the bathroom and I couldn’t walk, my feet hurt so bad. During that week the muscle weakness went up my legs, into my arms and hands and then to my neck. I went to five specialist to find out what is wrong with me and no one knew how to treat me. I was put on liquid minerals hoping this would increase the muscels that I lost. Although I took the Rhado blood test and passed it, it has been a year now and I still feel the same. My arms and legs are sore to touch and my legs are extremely week. If I have to get on my knees to clean I can not get up without holding on to something. It’s frustrating because all of the doctors say, sorry I don’t have a clue. If anyone feels the same way, I would appreciate an email back. I feel very much alone with this problem.

  • LAR // Nov 24, 2004 at 10:47 am

    I’ve been on Crestor for a year. My doctor switched me when he read a published article that verified my two year complaint of muscle soreness and weakness with Lipitor. I had previously had a similar reaction with Lescol.

    After this year on Crestor I have experienced weakness and pain in my back and from my elbows and knees down. I stopped the Crestor about a week ago and will wait a month to see if the signs ameliorate and don’t come back.

  • Terry Daly // May 10, 2005 at 12:04 pm

    Terry says,

    After reading all these accounts about Lipitor and Crestor, I now know I made the right decision when I decided to stop using Lipitor 20MG after two years of feeling miserable, getting up 5 or 6 times every night to go to the bathroom to urinate, sore muscles, sore back and legs, unable to do the walking I use to do, constant diarrhea. If this drug is suppose to prolong my life, I don’t think I want to live like this. I stopped using Lipitor the beginning of this month, and already I am starting to feel better, getting my life back again.

    Terry

  • amy wolons // May 11, 2005 at 3:02 pm

    I would appreciate if anyone has any info on the damaging effects of Rhabdo from zocor. As of today my father is in his fourth week in an icu. He was on life support for a week. As of now is on a feeding tube because of his muscles in throat being attacked by the rhabdo. There may be some qt. about his vascular system. If anyone has experienced the horrible effects of this drug I would appreciate information. Thank you!!!! Amy

  • Donna // May 24, 2005 at 3:38 am

    Although I did not take Crestor, I took Zocar/Zetia tablet combination, within slightly over two weeks of consuming this statin, I developed muscle weakness that developed to the point that I had almost loss all use of my legs, arms, hands. I also had intense muscle spasms over my entire body of which I am still having alabeit at a less intense level. I am, after three weeks of discontinuing use of the Zocar/Zetia tablet, still extremely weak in my limbs. My doctor stated that I had a rare but very severe reaction to the statin and that I will never be able to tolerate statin drugs. What I cannot find out, however, is once this happens is it permanent? As stated above, I have not taken the Zocar for about three weeks and I am still having neck,shoulder,leg spasm, arm pain, and still very weak. If anyone has experienced what I have or knows of a loved one or friend who has and can give me information as to how long it will be before I feel like myself again with muscle strength again, I would very much appreciate an email and hearing from them.

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