The Safety of Niacin in the US Food and Drug Administration Adverse Event Reporting Database

Of currently approved drugs, niacin is the most effective in raising high-density lipoprotein cholesterol levels, either as monotherapy or in combination with other agents. The US Food and Drug Administration’s (FDA) Adverse Event Reporting System provides 1 mechanism to evaluate the safety of niacin as it is used in common clinical practice. In this report, the authors review recent analyses of adverse events reported to the FDA demonstrating that the extended-release formulation of niacin (niacin-ER) has a significantly better safety profile compared with other niacin formulations and compares favorably with other commonly used lipid-altering drugs, including 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) and fibrates. In addition, analyses of FDA adverse event reports of the pill combining lovastatin and niacin-ER suggest that the safety of combination therapy with niacin-ER and a statin is comparable with the safety of each of the drugs alone. These analyses should encourage the use of niacin-ER in patients at high risk for cardiovascular disease, as recommended by current national guidelines for cardiovascular prevention.