THURSDAY, June 24, 2004 (HealthDayNews) -- A consumer health group, citing mounting cases of severe illness tied to the cholesterol-lowering drug Crestor, has taken its call for a ban on the pill to the pages of a leading medical journal.
"To allow AstraZeneca to continue desperately seeking a piece of the estimated $20 billion-a-year statin market hardly justifies governments allowing this ultimately doomed drug to stay on the market," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, writes in the June 26 issue of The Lancet.
An AstraZeneca representative, noting that Wolfe has opposed the drug since before it was approved, called his claims unfounded.
At the heart of Wolfe's argument are concerns that Crestor (generic name rosuvastatin) causes primary kidney failure and rhabdomyolysis, a breakdown of muscle fiber that also can cause kidney failure.
Between the drug's approval in August 2003 and mid-April, Wolfe stated, 18 users around the world, including 11 in the US, have suffered from rhabdomyolysis. Wolfe said all this data came from the FDA.
In the intervening two months, Wolfe said, there have been 20 more reports to the FDA, and there may be more from Canada. "Canada has eight cases of rhabdomyolysis, and it is my understanding that those cases are not yet reflected in FDA data," Wolfe said.
On June 21, Health Canada issued an advisory detailing a possible association between Crestor and rhabdomyolysis, recommending that all patients take the lowest possible dose and urging them to check with their doctor to see if they had one of the risk factors for developing the problem.
AstraZeneca denies that the drug's safety profile is any different from other statins and discounts the severity of the reports. "A report is not a confirmed case. Typically, if you were on a drug and got a headache and called your doctor, the doctor would file a report," said Gary Bruell, a spokesman for AstraZeneca.
"We believe Dr. Wolfe has made misleading claims based on inappropriate interpretation of data," Bruell said. "His views are well-known and have not changed since before the approval of Crestor, despite a continuous evolution of a large volume of data in support of the fact that Crestor's safety profile remains similar to that of other marketed statins."
Public Citizen filed a petition with the FDA in March to have the drug removed from the market. That petition is pending. Last month, the group renewed its call, but Jason Brodsky, an FDA spokesman, told HealthDay that the agency wasn't too concerned about the drug.
In 2001, Baycol, another statin, was voluntarily removed from the market by its maker, Bayer Corp., because of reports of sometimes fatal rhabdomyolysis.
According to Public Citizen, many of the reports of problems with Crestor occurred in people taking lower doses (10 and 20 milligrams), while pre-approval data had indicated toxicity in people taking the 80-mg dose, which was not approved. In The Lancet piece, Wolfe cited pre-approval documents from the FDA: "The data . . . show, for the first time, the development of severe myopathy and rhabdomyolysis in clinical trials submitted for the original approval of a new statin. This risk is clearly increased at the highest dose studied (80 mg), which has subsequently been discontinued from development. "
In June, AstraZeneca released a revised package insert for Crestor for use in the European Union. An FDA announcement stated that "these risk factors and many of the recommendations for how to minimize the risk of myopathy [diseases of the muscles] are already captured in the FDA approved labeling for Crestor in the U.S."
Wolfe said he had received a report of a patient with no contraindications for Crestor who had nevertheless developed rhabdomyolysis and had to go on dialysis temporarily. "Even if people don't die, having to go into renal failure, which is life-threatening, and being in kidney dialysis for a week or two or three is a pretty awful adverse reaction when they are other drugs that aren't as dangerous," Wolfe said. "The drug really does have unique dangers, and it shows no difference in terms of LDL ["bad" cholesterol]."
AstraZeneca, on the other hand, has a different point of view. "We have more than 2 million patients on Crestor, more than 5 million prescriptions dispensed, and we've not seen anything that was not seen in the clinical trials," Bruell said. "I don't want to give much credence to what Public Citizen is doing."
More information
For more on cholesterol-lowering drugs, including statins, visit the American Heart Association.
