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Drug Injury Lawyers

Crestor®

Do not discontinue taking any medications without first consulting your physician.

On March 4, 2004, Public Citizen, a consumer watch group, called on the FDA to remove AstraZeneca’s Crestor®, or rosuvastatin, from the market because of reports of life-threatening muscle damage, kidney failure or damage, and death.

FDA ALERT [03/2005]-Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. To date, it does not appear that the risk is greater with Crestor than with other marketed statins. However, the labeling for Crestor is being revised to highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg. Kidney failure of various types has also been reported in patients treated with Crestor as well as other statins.  Patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may also be at higher risk for kidney failure even when they are not taking statins.  At this time, the FDA cannot conclude that recommended doses of Crestor can cause or exacerbate renal failure, but is continuing to carefully evaluate the data.

What is Crestor®?
Crestor (rosuvastatin) is a cholesterol-lowering drug in the statin class that was approved by the FDA on August 13, 2003. This AstraZeneca drug is reported to lower LDL cholesterol by as much as 63% and is available in 4 doses: 5 mg, 10 mg, 20 mg, and 40 mg.

Like other statins, Crestor works by targeting the liver and blocking an enzyme involved in the production of LDL, or “bad,” cholesterol. AstraZeneca believes that Crestor is better than any previous statin at lowering LDL and raising HDL, or “good,” cholesterol. In turn, the lowered cholesterol levels are supposed to reduce the risk of heart attack, blood clots, stroke, and other heart problems.

What are the risks?
Used alone, drugs in the statin group carry a “small, but definite” risk of myopathy, or muscle disease, according to an August 2002 advisory published by the Journal of the American College of Cardiology. Crestor, however, takes this risk a step further.

In its first five months on the market, Crestor use has been attributed to three cases of kidney failure or muscle damage in the U.S. In one of those cases, a young woman died of kidney failure and rhabdomyolysis. In the U.S. , Canada , and the U.K. , there are seven documented cases of rhabdomyolysis and nine of kidney damage or failure resulting from Crestor since its FDA approval. In addition, before Crestor’s approval, seven cases of rhabdomyolysis were documented during its clinical trials.

Even Baycol®, which was eventually withdrawn from the market because of its rhabdomyolysis risks and is now associated with over 100 deaths, showed no evidence of serious rhabdomyolysis during its clinical trials. Crestor is the only statin to display these problems during its pre-approval studies and still gain approval by the FDA.

Moreover, Crestor has not been shown to reduce the risks of heart attacks and strokes, the main benefits associated with lower cholesterol levels.

What is rhabdomyolysis?
Rhabdomyolysis is the breakdown of muscle tissue that is accompanied by the release of muscle cell contents into the bloodstream resulting in blood problems and sometimes, serious kidney damage.

Symptoms of rhabdomyolyis may include:

• Muscle pain, tenderness, weakness, stiffness or spasms
  
• General weakness
• Dark urine
• Malaise and fever
  

What is being done to protect consumers?
Public Citizen’s Health Research Group has been vocal in its concerns about the approval of Crestor. Because of the rhabdomyolysis risks displayed during the clinical trials, Public Citizen called upon the FDA to deny Crestor’s approval in July 2003. In October 2003, after the approval, Public Citizen issued a warning about Crestor urging its readers not to use the drug. In March 2004, after reports of Crestor problems continue to surface, they are fighting to get the drug removed from the market before it is too late.

In addition, some insurers are choosing not to cover Crestor, hoping that action will deter doctors from prescribing this drug with questionable benefits.

The FDA has limited the distribution of the 40-mg. strength Crestor because of increased safety concerns associated with that high dosage. However, the FDA does not require routine urine testing of Crestor users, a test that may detect early any signs of kidney problems.

What should I do?
You should never discontinue taking any medication without first discussing it with your physician. However, if you are taking Crestor and are concerned about possible risks to your health, discuss with your doctor other options, including a different statin that may not pose the same serious health risks.

Do not discontinue taking any medications without first consulting your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Crestor® is a registered trademark of IPR Pharmaceuticals, Inc., one of the AstraZeneca group of companies, and is used here only for the purpose of identifying the product in question.

Baycol® is a registered trademark of Bayer Corporation. The reference to the registered trademarks of Bayer Corporation is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by or associated with Public Citizen, IPR Pharmaceuticals, Inc., the FDA, or the AstraZeneca group of companies.

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