In August 2003, the Federal Food and Drug Administration (FDA) approved Crestor, manufactured by AstraZeneca. Crestor belongs to a family of drugs called statins. The active ingredient, rosuvastatin, is in a class of medications called HMG-CoA reductase inhibitors - statins. Crestor became the sixth cholesterol-lowering statin drug on the market, following the drugs Lipitor, Pravachol and Zocor. These drugs combat cholesterol by blocking a specific enzyme in the body that synthesizes cholesterol. Between 2003 and 2006, Crestor was prescribed approximately 22 million times to more than 4.7 million patients. 

Less than four months after Crestor’s FDA approval, three U.S. patients who were taking approved doses of rosuvastatin developed Crestor-related serious side effects. These side effects included kidney failure and/or muscle damage. As with Baycol, another cholesterol-lowering medicine withdrawn from the market by Bayer Healthcare due to its serious side effects in August 2002, the muscle damage, known as rhabdomyolysis, deteriorates the kidneys.

In 2004 and 2005, several consumer groups asked the FDA to recall Crestor partially because of the reported serious complications within five months of the drug's initial approval. These groups cited the patients who developed kidney failure and/or muscle damage while taking approved doses of Crestor. The groups also noted that in studies that were conducted before Crestor's approval, seven people became ill with rhabdomyolysis.

In March 2004, Public Citizen (another consumer group) complained to the FDA about the negative effects of Crestor and asked that the drug be removed from the market. The FDA contended that Crestor's risks were no greater than those of its competitors, and rejected the consumer efforts to remove the drug from the market. However, in May 2005, the American Heart Association's journal, Circulation, published a report confirming the complaints of Public Citizen. The report suggested that users of Crestor were up to six times more likely to suffer complications, as compared to users of other statins. AstraZeneca has not removed Crestor from the market and continues to stand behind the safety and effectiveness of the medication as long as the product is used according to the prescribing information.

According to some reports, to date the FDA has received over 65 reports of rhabdomyolysis and 29 cases of acute renal failure or renal insufficiency out of 4.5 million Crestor prescriptions. This is similar to the rate associated with Baycol. That medicine was removed from the market after 31 reported cases of fatal rhabdomyolysis, none of which were identified before FDA approval.

In March 2005, the FDA issued a public Health Alert for Crestor stating the following:

“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 in the process of being revised to highlight important information on the safe use of Crestor to reduce the risks for serious muscle toxicity especially at the highest approved dose of 40 mg.”   

The FDA stated that the labeling was also being revised to reflect the results of a large pharmacokinetic study involving a diverse population of Asian patients compared with a Caucasian control group. This study found drug levels to be elevated at approximately twice the rate in Asian patients. Kidney failure rates of various types were also reported in the Asian patients treated with Crestor and other statins. 

Patients who are candidates for statin therapy (patients with diabetes, hypertension, atherosclerosis, and/or heart failure) may be at higher risk for kidney failure even when they are not taking statins. Additionally, the FDA has not been able to conclude that recommended doses of Crestor can cause or exacerbate renal failure as reported by some studies and patients.

The FDA approved the revisions to the Crestor prescribing information shortly after the public Health Advisory in 2005. The changes strengthened the language around the appropriate use of Crestor. At the same time, the FDA issued a statement that confirmed that the potential benefits of Crestor currently outweigh the potential risks when the drug is taken as directed. This does not mean that the potential for serious side effects does not exist.