AERS Database Cannot Determine Adverse Event Incidence, FDA Says In Rejecting Statin Label Warning
FDA denies Public Citizen’s 2001 petition requesting a black box warning about the risk of rhabdomyolysis on cholesterol-lowering drug labels, says Baycol and high-dose simvastatin are outliers.
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With cheap, proven statins aplenty, cost constraints are “off the table” when it comes to vastly broadening primary prevention, authors of new cholesterol guidelines say at the 2013 AHA meeting. However, evidence for drugs to lower triglycerides and boost HDL is lacking, and focus should be on lifestyle change, they say.