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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Time, And Price, Are Right To Prescribe Statins To the Masses
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.
SEARCH Ends Badly For Simvastatin 80 Mg; FDA Restricts Use To Existing Patients
New clinical trial data and adverse event reports show high-dose simvastatin-containing products have a greater risk for muscle toxicity than other statins, the agency concludes.
AstraZeneca Defends Crestor; Public Citizen Renews Call For Withdrawal
The post-marketing safety profile of Crestor is in line with the overall experience of the statin category, AstraZeneca said May 19 in response to a renewed request from Public Citizen for withdrawal of the cholesterol-lowering drug