Public Citizen Advocacy Group Petitions FDA to Ban Crestor

Citing seven cases of life-threatening rhabdomyolysis (muscle destruction) and nine cases of kidney failure or kidney damage in patients using low doses of Crestor, US consumer advocacy group Public Citizen petitioned the FDA to ban the cholesterol-lowering drug Crestor from the market. According to Public Citizen's Dr. Sidney Wolfe, "Crestor has no unique advantage, but some unique risks" over other statins, such as an ability to cause primary kidney damage including failure. Two health insurers agree:

Two major U.S. insurers, WellPoint/Blue Cross, with 15 million patients insured, and Group Health Cooperative of Puget Sound (GHCPS) with more than 500,000 members have refused to reimburse for Crestor. "We've already been Baycolled," said Dr. Robert Seidman, chief pharmacy officer for the Thousand Oaks, Calif.-based WellPoint. "There is a level of nervousness, and we're being conservative and we're being cautious," Seidman also said.

Baycol, or cerivastatin, was banned after 31 cases of fatal rhabdomyolysis, none of which were seen prior to approval. In contrast, there were seven cases of rhabdomyolysis in patients receiving Crestor (rosuvastatin) before its approval. All were receiving a dose of 80 milligrams, which was not approved by the FDA, but as Public Citizen points out, "a small patient getting even the 40 milligram dose might be receiving the same amount of drug per pound of body weight and we were concerned that cases would occur at this 40 milligram dose or even lower doses."

More recently, Medco Health Solutions has decided not to reimburse for Crestor and United Health Care has placed Crestor in the highest tier of three out-of-pocket categories to discourage use of Crestor.

Crestor, or rosuvastatin, which was approved by the FDA in August 2003, is marketed by AstraZeneca as a "super-statin" because it is the strongest of all statins currently on the market, a point which concerns Public Citizen:

Bayer withdrew cerivastatin in August, 2001, after the occurrence of unexpected cases of fatal rhabdomyolysis. The 80 mg dose of rosuvastatin was withdrawn by AstraZeneca because of safety concerns. Some critics are even anxious about the 40 mg dose. The finding of proteinuria [protein in the urine] and microscopic haematuria [blood in the urine] associated with rosuvastatin use are additional worries. Since there are no reliable data about efficacy [that is, actually decreasing heart attacks and strokes, not merely lowering cholesterol levels] and safety--and AstraZeneca is facing unusually acute commercial pressure to force rosuvastatin into the market--doctors should pause before prescribing this drug. Physicians must tell their patients the truth about rosuvastatin--that, compared with its competitors, rosuvastatin has an inferior evidence base supporting its safe use. AstraZeneca has pushed its marketing machine too hard and too fast.

Public Citizen says that in the past it has been instrumental in inducing the FDA to remove products such as Rezulin (diabetes drug) and Redux (weight loss drug) from the market.

Read more about Crestor on our Crestor Information Page