Public Citizen, FDA Disagree Over Crestor

Washington, DCThe risk of Crestor side effects may not be high on the list of concerns of many patients, but Public Citizen, a public interest advocacy group, is worried about Crestor issues. Before the drug was even approved for use, Public Citizen argued against it, stating that Crestor rhabdomyolysis was a serious enough issue to stop the drug from being approved.

The FDA ultimately approved Crestor for use, but Public Citizen continued to argue against it. On March 4, 2004, Sidney Wolfe, director of the Public Citizen Health Research Group, wrote to the FDA, requesting Crestor (known generically as rosuvastatin) be removed from the market citing concerns about rhabdomyolysis and kidney failure.

"We have obtained new information from the FDA and health agencies in Canada and the U.K. concerning serious post-marketing adverse reactions—including seven cases of life-threatening rhabdomyolysis (muscle destruction) and nine cases of kidney failure or kidney damage—in patients mostly using lower doses of this recently-approved cholesterol-lowering drug, rosuvastatin," Wolfe wrote.

Wolfe argued that kidney failure and signs of kidney problems—including protein and blood in the urine—are unique to statin drugs, but "rosuvastatin is the only one of these drugs in which any cases of the life-threatening muscle destruction known as rhabdomyolysis was found to occur prior to approval."

Public Citizen argued against approval of Crestor on the market on the basis of reports of kidney failure and kidney insufficiency in patients. The public advocacy group noted that although reports of problems occurred in patients taking 80 mg of the drug, a dose that was not approved by the FDA, smaller patients taking 40 mg of Crestor could receive the same amount of drug per pound as a larger person at the 80 mg dose.

Wolfe's letter highlighted the case of a 39-year-old woman who was taking only 20 milligrams of Crestor a day when she died of rhabdomyolysis and renal insufficiency. According to Public Citizen, the total number of new cases of adverse reactions after Crestor was approved in the US, Canada and UK includes seven patients with rhabdomyolysis, four patients with acute kidney failure, five patients with kidney damage and six patients with bleeding or abnormal bleeding tests, likely linked to a drug interaction between Crestor and a blood-thinner.

So far, the FDA has maintained its stance that the benefits of statin drugs including Crestor outweigh the risks.