Crestor, manufactured by AstraZeneca Pharmaceuticals, was approved by the Food & Drug Administration (FDA) in August 2003. Marketed as a “super-statin,” Crestor was alleged to lower LDL cholesterol more than other statin drugs. Statins differ in the way they are broken down or expelled by the body. Whereas most statins are metabolized through the liver and have half-lives of 1 to 3 hours, Crestor is cleared mostly through the bile and it has a half-life of about 19 hours. It is argued by some that Crestor’s increased time in the body may contribute to more severe side effects.
In March 2004, the non-profit organization, Public Citizen, requested that the FDA remove Crestor from the market, stating that Crestor’s side effects were severe and that the drug should never have been placed on the market. According to a study published in 2004 by the American Heart Association’s Journal, Circulation, Crestor was found to be approximately two to six times more likely to cause adverse side effects over a one-year period as some of the other statins then available on the market.
On June 9, 2004, the FDA issued a Public Health Advisory for Crestor, warning of the “increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg.”
In March 2005, the FDA issued an alert, warning that “[r]habdomyolysis (serious muscle damage) ha[d] been reported in patients taking Crestor as well as other statin drugs. The labeling for Crestor [wa]s 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.”
In 2010, approximately 25 million Crestor prescriptions were dispensed in the US. Crestor has been associated with the following adverse side effects:
- cardiomyopathy, or muscle heart disease
- acute kidney failure
- kidney damage
One of the first Crestor lawsuits was filed in 2005, by a Pennsylvania woman who claimed that the drug led to her daughter’s death from kidney damage and muscle weakness. The mother sought compensatory and punitive damages from AstraZeneca for the death attributed to Crestor. The lawsuit charged that AstraZeneca encouraged improper use of Crestor, misrepresented the safety and effectiveness of the drug and concealed or understated its dangerous side effects.
If you, or someone you known, has been injured after taking Crestor, please contact us for a free consultation so that we may discuss your case in more detail.