SEARCH Ends Badly For Simvastatin 80 Mg; FDA Restricts Use To Existing Patients
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
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.
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.
In shifting away from specific targets and non-statin add-on therapies, new ACC/AHA cholesterol guidelines support treatment of people at relatively low risk for events and more intensive therapy for those at higher risk.