UK investors were returning to AstraZeneca’s stock this morning after the US Food and Drug Administration yesterday said that the benefits of taking the Anglo-Swedish firm’s cholesterol lowering agent, Crestor (rosuvastatin), outweighed the risks, and that the chances of developing muscle damage – or rhabdomyolysis – were similar to other drugs in the statin class.
AstraZeneca has updated the Crestor label to again highlight that doctors should consider using the lower starting doses of the drug in some patients to reduce the risk of rhabdomyolysis.
In addition, the FDA said it could not confirm, with available data, whether recommended doses of Crestor or other statins could cause of worsen kidney damage. “Patients who are candidates for statin therapy… may be at higher risk for kidney failure even when they are not prescribed statin therapy.”
However, the news was not welcomed by influential US consumer group, Public Citizen, which said the FDA showed “dangerous cowardice in failing to adequately protect people… from uniquely dangerous prescription drugs.” It accused the agency of communicating “false and misleading” information and said that it had made minimal label changes instead of adequately responding to Public Citizen’s repeated calls for the drug’s ban [[01/11/04b]], [[05/03/04a]]. The group claims that, since Crestor won US approval in 2003 [[13/08/03a]], 117 cases of rhabdomyolysis and 41 cases of kidney failure, both higher than seen with the other currently marketed statins, had been documented. “In its inability to serve two masters, the FDA has sided once again with its funders in the drug industry,” Public Citizen concluded.