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Open Access Highly Accessed Research article

The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903]

Edward Mills12*, Jonathan Prousky1, Gannady Raskin3, Joel Gagnier4, Beth Rachlis1, Victor M Montori5 and David Juurlink6

Author Affiliations

1 Department of Research, Canadian College of Naturopathic Medicine, North York, Canada

2 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada

3 Department of Academics, Bastyr University, Seattle, USA

4 Department of Clinical Epidemiology, University of Toronto, Toronto, Canada

5 Division of Endocrinology, Diabetes, Metabolism, Nutrition, and Internal Medicine, Mayo Clinic, Rochester, USA

6 Department of Medicine, University of Toronto, Toronto, Canada

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BMC Clinical Pharmacology 2003, 3:4  doi:10.1186/1472-6904-3-4

Published: 13 November 2003

Abstract

Background

Niacin is widely available over the counter (OTC). We sought to determine the safety of 500 mg immediate release niacin, when healthy individuals use them as directed.

Methods

51 female and 17 male healthy volunteers (mean age 27 years SD 4.4) participated in a randomized placebo-controlled blinded trial of a single dose of an OTC, immediate-release niacin 500 mg (n = 33), or a single dose of placebo (n = 35) on an empty stomach. The outcomes measured were self-reported incidence of flushing and other adverse effects.

Results

33 volunteers on niacin (100%) and 1 volunteer on placebo (3%) flushed (relative risk 35, 95% confidence interval (CI) 6.8–194.7). Mean time to flushing on niacin was 18.2 min (95% CI: 12.7–23.6); mean duration of flushing was 75.4 min (95% CI: 62.5–88.2). Other adverse effects occurred commonly in the niacin group: chills (51.5% vs. 0%, P < .0001), generalized pruritus (75% vs. 0%, P = <.001), gastrointestinal upset (30% vs. 3%, P = .005), and cutaneous tingling (30% vs. 0%, P = <.001). Six participants did not tolerate the adverse effects of niacin and 3 required medical attention.

Conclusion

Clinicians counseling patients about niacin should alert patients not only about flushing but also about gastrointestinal symptoms, the most severe in this study. They should not trust that patients would receive information about these side effects or their prevention (with aspirin) from the OTC packet insert.

Keywords:
Over-the-counter; Randomized controlled trial; Niacin