This week, the FDA took the unusual step of withdrawing approvals it had previously given for several medications used in conjunction with statins to treat high cholesterol. This is news because I’m sure many of you have been paying big bucks for these medications.
Which meds are we talking about?
- Extended-release niacin (Niaspan).
- Fenofibric acid delayed-release (Trilipix)
- Combination therapies Simcor (simvastatin + niacin) and Advicor (lovastatin + niacin) which were already voluntarily pulled at the end of 2015.
Why did the FDA pull approval of these meds?
Because they haven’t been shown to have any benefit. Simply put, when added to statin therapy (atorvastatin/Lipitor, simvastatin/Zocor, Crestor) for lowering triglycerides or raising HDL cholesterol, they haven’t been shown to reduce risk of heart disease or stroke. So, they don’t really help you.
Based on several large trials, the FDA decided that “scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events.”