Crestor (rosuvastatin) is an HMG CoA reductase inhibitor, manufactured by AstraZeneca. Crestor is within the class of anti-cholesterol drugs called statins, and works by blocking the production of cholesterol. Cholesterol, which is produced in the liver, is important to the health of cell membranes and to the production of certain hormones.
Another anti-cholesterol statin, Baycol, was approved for use by the Food and Drug Administration in 1997. When Baycol proved ineffective at the dosage approved by the FDA, Bayer, the manufacturer of Baycol, requested approval from the FDA for the prescription of higher doses.
Over subsequent years, while Baycol grew in popularity, numerous negative health consequences started to become apparent, including rhabdomyolisis (a muscle condition with symptoms including weakness, nausea, fever, muscle pain, muscle cell atrophy, and which sometimes results in kidney failure and death). Bayer voluntarily removed Baycol from the market in 2001, by which time at least 52 deaths had been attributed to the use of Baycol.
In March, 2004, responding to reports that Crestor patients were also suffering from rhabdomyolysis at a higher rate than with other statins, the consumer group Public Citizen complained to the FDA and asked that the drug be removed from the market. The FDA rejected that petition in March, 2005.
However, in May, 2005, the American Heart Association's journal, Circulation, published a report confirming the complaints of Public Citizen. The report suggests that users of Crestor are up to six times as likely to suffer complications, as compared to users of other statins.
AstraZeneca responded by asserting that Crestor was safe, and that serious side-effects are very rare, with rhabdomyolysis occurring at a rate of less than 1 case per 10,000 users. In anticipation of possible litigation, a number of law firms recruited clients who believe they may have been injured as a result of Crestor use.
On March 11, 2005, the FDA issued a letter rejecting the allegations made by Public Citizen, including its findings that Crestor posed no special safety risk as compared to other statins. Crestor remains on the market.