Public Citizen today called on the U.S. Food and Drug Administration to withdraw the cholesterol-lowering drug Crestor from the market. Crestor, which is marketed by AstraZeneca, has been linked to cases of life-threatening muscle damage and kidney failure or damage, says the consumer advocacy group.
“The FDA should never have approved this drug in the face of such serious and potentially lethal adverse effects,” Public Citizen Health Research Group Director Sidney Wolfe, M.D. said. “The only way the agency can show it has concern for patient safety, and not drug industry wishes, is to pull Crestor from market immediately.”
The FDA approved Crestor just five months ago.
Public Citizen claims three patients in the U.S. who were taking approved doses of Crestor developed kidney failure or muscle damage.
“We have obtained new information from the FDA and health agencies in Canada and the U.K. concerning serious post-marketing adverse reactions – including seven cases of life-threatening rhabdomyolysis (muscle destruction) and nine cases of kidney failure or kidney damage – in patients mostly using lower doses of this recently-approved cholesterol-lowering drug, Crestor,” Dr. Wolfe said in a petition to FDA today.
In July 2003, Dr. Wolfe strongly urged the FDA not to approve Crestor, because in addition to the risks of muscle and kidney damage, Crestor has not been shown to reduce the risk of heart attacks and strokes, in addition to lowering cholesterol levels.
In the petition to the FDA, Public Citizen highlighted how two major U.S. insurers, WellPoint/Blue Cross and Group Health Cooperative of Puget Sound, have refused to reimburse for Crestor.
AstraZeneca is getting ready to launch a major direct-to-consumer advertising campaign to promote Crestor, Public Citizen said in a press release issued today.
(via Public Citizen)
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I have been on Crestor for about 2 months. I have noticed severe pain in my ankles -sometimes I can barely walk after sitting still for a few minutes. My cholesterol has been lowered drastically and that is good news. The bad news is that every joint in my body aches at night and I have severe sciatic pain. I also have lower back pain and suspect a kidney or bladder infection.
The same person who is making all of these claims against Crestor (Sidney Wolfe) has also made them against all of the other cholesterol lowering drugs. If you think the number of adverse reactions he reports with Crestor are bad you should check out what he says Lipitor, Zocor, and Pravachol have done to people. Here is a petition to the FDA from Sidney Wolfe which can be easily found by going to his website “worstpills.org”. http://www.citizen.org/publications/release.cfm?ID=7051
It is a fact that Crestor is just as safe, if not safer, than all of the “statin” drugs. It is also a fact that Crestor lowers cholesterol far more than the others as well.
Wow! I checked out the site Jose mentioned. I can’t believe that in a three year period Zocor killed more people than Baycol, and Lipitor came pretty close too. Baycol-20 deaths, Zocor-24 deaths, Lipitor-13 deaths. Maybe Crestor is the safest, I can’t find anywhere that says Crestor has any deaths related to it.
Would someone just list the facts about this drug once and for all. I’ve been to the FDA and the European regulatory bodies. These very highly respected MEDICAL experts all endorse Crestor as a very useful new drug with a great safety profile. ALL statins cause side effects, do a search and they’ll all show up with similar bad reports- all rare as well. The FACTS people!! Stop depending on lay persons opinions on a specialist product.
I’m 40 years old and have had a triple bypass. Heart disease doesn’t run in my immediate family, however, I had an uncle die of a heart attack at age 50. I was on 80 mg of zocor, niaspan, & folic acid to try to get my cholesterol under control. Also, I was on the treadmill for 45 min every other day & watched what I ate. Despite all the meds, exercise, & watching what I ate, my ldl was still too high considering my history. For the last year, my cardiologist has me on 40 mg of Crestor & 10 mg of Zetia. He took me off the Zocor-80 mg, Niaspan – 1000 mg, & folic acid – 5 mg. On my last blood test, my total cholesterol was 141, ldl – 95, triglycerides – 135, & hdl – 35. Per my cardiologist, my liver function & CK were normal. However, at times I do have flank pain in my back. I’m kind of worried about all this news on Crestor. Also, it seems that everyone commenting are on lower doses. I’m kind of indecisive about what to do.
I wish that astra zeneca would sue wolf for this situation. as a matter of fact, i wish doctors would organize a class action suit and sue for the amount of time we have lost having to tell peole why Crestor is a good drug and should not be taken off the market. this is getting ridiculous and is a huge waste of physician’s time and their nurse’s time
Istarted taking crestor 10 mg about a month ago and everything has went down but I’m worried what I hear on TV and read about on the wed please help me to better understand the drug and what to look for if something does happen my Dr say not to be worried that it is safe but how can you not worry about it.
i have been taking crestor since december2003. i have now voiced my concerns to my practioner. i am now scheduld to have blood work done to acess any damage that may have occoured. i have been suffering pain in my wrists hands knees and bad swellng in my lower legs. i have also been dizzy and headachy frequenly this is my first time to be prescribed statins.
If you are not a Pfizer or Merck representative and you are a patient having aches and pains on any statin. Perhaps you should realize you are getting older and you are probably dehydrated. Get out and get some exercise and get off your butt!
This Public Citizen hogwash is only to benefit public citizen and its backers. Don’t believe what you hear from them, read, or search on the web. Theese lawyers only want the money. YOUR MONEY! You will only come out in the end with what you started with. NOTHING!
Been on Crestor 2 weeks, have very serve back and shoulder pain. Did not have this pain with Lipitor. Take 80 MG of lipitor
Glenda stop taking the Crestor if you have sciatic pain. My sciatic attack was over a year ago and I still have balance problems, muscle cramps, foot drop, weakness in muscles especially in the legs.
I have been on crestor for 8 days. I was wondering why I had severe back pain, knee pain and last 3 days stomache pain and cold sweats day and night.I also feel very weak. My Doctor said there were no side effects.I had no idea until the last 10 minutes there were. I think I will visit my Doctor tomorrow.
I’ve taken Crestor 10mg/day and reduced to 10/mg every other day but I’m still feeling weakness in my grip stength and sore hands and wrists as well as general fatigue.
I’m 60 and have been working out since my 30’s with weights, machines, and aerobic machines.
I had taken Lipitor prior to Crestor and got muscle aches but not this weakness in my wrists and hands. My upper body strength otherwise is unchanged. I see my cardiologist tomorrow and will ask him about changing to Pravachol.
Dr. put me on Crestor. A few days later I started muscle cramps in my right shoulder and upper arm area. I thought I pulled a muscle. Then I started hearing about the side effects from Crestor and I got worried. I stopped taking it. It has now been five weeks and I still have the weakness, but not as bad. It hurts worse when I lay down–makes it hard to sleep. Am I wrong to stop taking it? I only take one prescription–Norvasc–for HBP. So I am not on many other drugs that could possiblly cause this. And I only started noticing it after I began taking the Crestor.
My Mom was on Crestor for about 2 months before her doctor noticed her severe muscle deterioration. I live in a different state and did not see her for about six weeks. I was surprised that a vibrant 60-yr-old suddenly looked like a weak 80-yr-old. The doctor even went as far as to test her for MS and other muscle diseases, but found none. I firmly believe that had she stayed on Crestor any longer, she would have died. The good news is that now that she has switched to another drug, her strength is beginning to return. Crestor should be removed from the market. It is not safe!
I’ve been on Crestor for almost a year. No side effects on 20mg, prior I was on 80mg of Lipitor. I also take 10 of Zetia and 500 of Niaspan. My LDL was over 310 and my HDL was under 20, with the current meds my LDL is below 100 and my HDL is getting in the low 30s. I follow diet and exercise rules almost to the letter, I’m not overweight and I’m under 40.
I tried diet and exercise alone, it earned me a bypass. Without Statins, I don’t think I’d make it another five years.
My Doctor put me on Liptor, I got ill with flu like symptoms in three days, They changed me to Provacol and zetia for a year, I had slight muscle pains, but no great drop in levels. Same Doc put my on Crestor 12 weeks ago, All levels improved, no pains, no side effects so far. But he is also monitoring blood work at 8 week intervals. So I will wait and see, but it has been the most effective so far on improving all Levels and not causing side effects.
i have been taking crestor for the past 5 months. i have had sever stomach pain off an on during that time. i dont know if its the crestor, but it seems like it could be. is there any problem with stopping it “cold turkey”?
As followup to my last comment. It has been one year on Crestor. My Chol is 125 (high 293), my LDL is 64 ( high 190) and my CPK is normal (180). My BUN and Cr are normal. On lipitor, my cpk went to 8,000, with myalgias.
Crestor is the only alternative to the other statins. They are lipid soluble, and share the same risk profile. Crestor is water soluble and tolerated by most who can’t take the others. Removing it from the market eliminates an option for many patients.
I’ll take my chances with Crestor, since my chance of dying from cardiovascular disease is greater without it.
BY the way, I’m not a McDonalds addict. I’m 6″ 2″ and 179 pounds, and exercise and diet aren’t enough.
ive been on crestor 10mg.for about 8 months,ive had severe muscle spasms in my feet and toes.Also,in the backs of my thighs i get charley horses constantly.
Crestor has lowered my total cholesterol from 240 -> 170. I’ve been on it about 10 months. Never had problems before, but have lately been waking up with leg cramps, also my ankles, wrists and fingers are swollen and ache, and now I’m getting cramps in the back of my thighs, all on and off over about a month. Had some similar problems (Swelling, but not the cramps) from the BP medicine I’m on when I first started taking it (HCTZ), but it went away after a few weeks. Anybody else take both of these meds?
I am very concerned about my mother. She has been having severe muscle problems in her legs since February and was taking Zocor. She has been taken off Zocor but her CPK level is very high. In reading the above, I am even more worried about her health. No doctors seem to be concerned or even seem to know what it is. She’s now been diagnosed with spinal stenosis and may need surgery for this. We really don’t know what to do. Most of all, we don’t know what doctor to go to who will listen and assess her situation properly. Any suggestions?
I have been on Crestor for over a year. No side effects except for elevated Muscle enzymes at the last test. What I have noticed is my skin seems to have aged more quickly than I expect it should be. Total body is a lot more wrinkly. Has anyone else had this effect?
Been on Lipitor 40mg and experienced muscle weakness and numbness after 2 years. Been on 5mg of Crestor for 4 weeks and experience change in bowels, stomach cramps, back aches and sleeplessness, light colored stool, swollen abdomen. I think I’ll call my doctor asap about this.
Since taking Crestor for two weeks, ending about a month ago, I’ve had severe diarrhea. Uncontrollable completely liquid diarrhea. Will this situation resolve itself?
Note that since the diarrhea started, I haven’t taken any more Crestor.
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