AstraZeneca says that the US Food and Drug Administration has formally rejected Public Citizen’s petition to remove the Anglo-Swedish company’s cholesterol-lowering drug, Crestor (rosuvastatin) from the market, on the back of what it terms was a “thorough analysis of clinical trial safety data and post-marketing data” [[03/03/05b]].
Earlier this month, the influential US consumer group repeated calls for Crestor to be pulled from the market, citing risks of rhabdomyolysis (muscle weakness) and kidney damage that were higher than with any other marketed statin drug [[03/03/05b]]. It has been campaigning for the drug’s withdrawal since it won FDA approval back in the summer of 2003 [[19/09/03a]], [[05/03/04a]], [[01/11/04b]].
In its 36-page response, the FDA stated that all of the available evidence indicates that Crestor does not pose a risk of muscle toxicity greater than the other approved statins, and that there is no convincing evidence that Crestor poses a serious risk of renal injury. “We conclude that the available evidence concerning Crestor’s safety does not warrant the withdrawal of Crestor from the market,” the letter stated. The agency noted that AstraZeneca had recently agreed to revise the Crestor label and issue a Dear Doctor letter to address certain concerns relating to the product’s use [[03/03/05b]].
However, Public Citizen is not taking the news lying down and has issued a statement slamming the FDA for once again “choosing [a] drug company over safety.” In a statement published on its website, Sidney Wolfe, director of Public Citizen’s health research group, said: “Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company, AstraZeneca, instead of the public. When Crestor is taken off the market, if not before, this will represent yet another blow to the agency’s badly tarnished reputation.” He said that making Crestor a last-choice for cholesterol lowering, “it would have been a much less reckless choice than merely allowing cosmetic labelling changes to be made.”