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Public Citizen consumer group has been pushing government regulators to pull Crestor from the market because of safety concerns. Now, the group has argued AstraZeneca should be the subject of an FDA criminal investigation for illegally delaying the submission of reports of serious adverse reactions to Crestor.
The FDA requires drug companies report serious and unexpected side effects within 15 days of learning about them so that the drug agency is able to properly determine if the drug has higher risks than initially believed. Public Citizen has charged AstraZeneca delayed its reports by as long as 97 days, arguing the 19 cases of rhabdomyolysis and four cases of kidney damage should have been considered serious enough for immediate reporting. Rhabdomyolysis is a potentially life-threatening muscle breakdown condition.
Despite negative publicity that has continued to surround Crestor, the number of prescriptions written for the cholesterol drug has only grown. The FDA has responded to the Public Citizen''s latest allegations by saying it is looking into the group''s charges and will take any necessary action deemed necessary following.
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