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FDA Revokes Approval of Niacin and Fenofibric Acid

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Shalini Shah1 year ago

Niacin and fenofibric acid were previously approved by the Food and Drug Administration (FDA) to treat high cholesterol. However, the federal regulator is now revoking their approval.

Reasons for Pulling Medication

According to Medscape, the FDA is now citing lack of benefit of cardiovascular benefits of niacin and fenobric acid and withdrawing approval of the medication.

Pulling approval for niacin and fenofibric acid affects the indication of niacin extended-release (Niaspan, AbbVie) and fenofibric acid (Trilipix, AbbVie). Additionally, it affects Advicor and Simcor.

In 1997, the FDA approved Niaspan for several indications and later indicated in combination with simvastatin or lovastatin to treat primary hyperlipidemia and mixed dyslipidemia. Trilipix gained FDA approval in 2008 as an adjunct to diet in combination with a statin to reduce triglycerides and increase HDL cholesterol

Sever large cardiovascular outcome trials were conducted like AIM-HIGH, ACCORD, and HPS2-THRIVE. These trials indicated that scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL cholesterol results in a reduction of risk in cardiovascular events.

Thus, the FDA has determined the benefits of niacin tablets and fenofibric acid capsules no longer outweigh the risks.

Information Regarding Use and Risks of Niacin and Fenofibric Acid

Niacin is usually taken as a cholesterol treatment to boost levels of good HDL cholesterol and lower trigylcerides. It is often prescribed in combination with statins for cholesterol control. However, niacin is effective mostly in high doses and pose the following risks:

  • Liver damage
  • Gastrointestinal problems
  • Glucose Intolerance

Fenofibric acid is used along with a proper diet to help lower bad cholesterol (LDL) and raise the good cholesterol(HDL). This occurs by increasing enzyme that breaks down fats in the blood. Fenofibric acid helps lower high triglyceride levels and can decrease the risk of pancreas disease. 


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