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


CONCLUSIONS
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.
Mills
Edward
E
Department of Research, Canadian College of Naturopathic Medicine, North York, Canada. emills@ccnm.edu
Prousky
Jonathan
J
Raskin
Gannady
G
Gagnier
Joel
J
Rachlis
Beth
B
Montori
Victor M
VM
Juurlink
David
D
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005483:Flushing / Q000139:chemically induced*; D005767:Gastrointestinal Diseases / Q000139:chemically induced*; D006801:Humans; D000960:Hypolipidemic Agents / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000009:adverse effects*; D010919:Placebos; D012449:Safety
D000960:Hypolipidemic Agents; D010919:Placebos; D009525:Niacin