The widely-prescribed cholesterol-lowering drug Crestor (generic: rosuvastatin) has been increasingly linked to cases of life-threatening muscle damage, heart injury, and kidney failure. Considering the severity of these potential side effects, the consumer watchdog group Public Citizen has petitioned for Crestor to be recalled nationwide. The group cited too few clinical trials, the potential for numerous adverse complications, and the fact that Crestor has not been shown to lower the number of heart attacks and strokes, while three other similar statins have shown this benefit without the risk.
Crestor Update 3/1/12: The U.S. Food & Drug Administration (FDA) issued a press release today informing healthcare professionals of updates to the prescribing information concerning adverse interactions between protease inhibitors and certain statin medications. When these two types of drugs are taken together, they may raise the blood levels of statins and increase the risk of a severe muscle injury known as myopathy.
Crestor Update 2/28/12: The U.S. Food & Drug Administration (FDA) issued a press release today stating that it will be requiring all statin drugs to carry a new warning about the increased risk of elevated blood sugar and possible transient memory and cognition problems. The label changes will apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), and Advicor.
What is Crestor?
Manufactured and marketed by AstraZeneca, Crestor is an FDA-approved statin medication designed to work by blocking the production of cholesterol in the body. Crestor reduces levels of ‘bad’ cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while simultaneously increasing levels of ‘good’ cholesterol (high-density lipoprotein, or HDL). The drug is approved to treat high cholesterol in adults and children who are at least 10 years old. Lowering cholesterol levels can help prevent heart attacks, strokes, and vascular disease. In addition to Crestor, other medications in the statin class include Zocor, Vytorin, Lipitor, Simcor, Lescol, Mevacor, Altoprev, Livalo, Pravachol and Simlup.
Side Effects of Crestor
Unfortunately, Crestor and other similar statin drugs have been increasingly linked to a number of serious side effects including:
- heart attack
- type 2 diabetes
- cardiac death
- kidney failure
- liver damage
Crestor & Cardiomyopathy
A 2009 study published in The Lancet found that statin drugs like Crestor have the potential to cause serious heart problems, including a life-threatening disease known as cardiomyopathy. Patients suffering from Crestor-induced cardiomyopathy may experience:
- difficulty breathing
- swelling of the feet or ankles
- rapid heart beat
- other symptoms indicative of heart problems
The authors of the study stated that the results of the research may have been due to a “… reduction in the concentration of coenzyme Q10 or ubiquinone, which is known to be caused by statins.”
Crestor Kidney Failure
The term ‘kidney failure’ refers to the sudden loss of the ability of the kidneys to remove waste and concentrate urine without losing electrolytes. Kidney failure can occur from an acute situation, chronic problems, or from high doses of statin medications like Crestor. Signs and symptoms of Crestor-induced kidney failure may include:
- weight loss
- nocturnal urination
- more or less frequent urination habits
- bone damage
- muscle cramps
- abnormal heart rhythms
- muscle paralysis
- swelling of the legs, ankles, feet or hands
- low blood pressure
Crestor & Rhabdomyolysis
Among the most severe side side effects to be associated with Crestor is rhabdomyolysis, a condition characterized by a breakdown of muscle tissue in the body. If left untreated, rhabdomyolysis can cause the release of protein myoglobin into the bloodstream, resulting in acute tubular necrosis, kidney failure, and even death. Signs and symptoms of Crestor-induced rhabdomyolysis may include:
- symptoms of kidney failure, which may include swelling of the hands or feet
- shortness of breath as excess fluid builds up in the lungs
- palpitations due to heart rhythm disturbances
- unexplained bleeding
In March 2004, the consumer protection group Public Citizen submitted a petition to the U.S. Food & Drug Administration (FDA) to have Crestor banned nationwide, as the drug had been linked to numerous cases of severe muscle damage and kidney failure only months after its approval. In the petition, Dr. Sidney Wolfe cited the abnormally high number of complications associated with Crestor, as well as the fact that there had been too few clinical trials conducted on the drug prior to its release. The petition also mentioned that two major health insurers and the Swedish government felt Crestor was so dangerous they decided not to reimburse patients for prescriptions of the drug. Although the FDA has still not recalled Crestor, patients injured by the drug’s side effects may be eligible to file a lawsuit to obtain compensation for their injuries.