FDA Approval Revoked for Several Popular Cholesterol Drugs

Dr. Sharon Orrange
Dr. Orrange is an Associate Professor of Clinical Medicine in the Division of Geriatric, Hospitalist and General Internal Medicine at the Keck School of Medicine of USC.
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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?

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.”

The benefits of niacin extended release tablets and fenofibric acid capsules listed above, for use alone or with your statin medications, no longer outweigh the risks.

Thoughts?

Dr O.

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