| Literature DB >> 14614780 |
Edward Mills1, Jonathan Prousky, Gannady Raskin, Joel Gagnier, Beth Rachlis, Victor M Montori, David Juurlink.
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.Entities:
Mesh:
Substances:
Year: 2003 PMID: 14614780 PMCID: PMC280687 DOI: 10.1186/1472-6904-3-4
Source DB: PubMed Journal: BMC Clin Pharmacol ISSN: 1472-6904
Warnings & Precautionary Statements of Niacin Supplements from Different Vitamin Companies
| Product 1. 500 mg caplets | Niacin may cause flushing, itching or burning sensations of the skin within twenty minutes after administration. Individuals with a history of ulcer, gallbladder or liver disease should consult their physician before use. |
| Product 2. 500 mg tablets | Temporary flushing, itching or warming of the skin may occur. Do not use in cases of gout, diabetes, liver dysfunction or pregnancy. |
| Product 3. 500 mg tablets | It is important to consult your physician before taking any nicotinic acid product. Do not use in case of pregnancy, gout, diabetes, ulcers or liver dysfunction without medical supervision. Temporary flushing, itching or warming of the skin may occur. |
| Product 4. 500 mg tablets | May cause mild flushing, itching or burning sensation of the skin within twenty minutes after administration. Those individuals with a history of ulcer, gallbladder or liver disease should consult their physician before taking these tablets. |
| Product 5. 500 mg tablets | May cause some flushing, itching or burning skin sensations. In case of a history of ulcers, gallbladder or liver disease, consult a physician. |
Figure 1Results form.
Figure 2Flow of participants throughout the trial.
Study Participants
| Age, years, mean (SD) | 27.2 (5.23) | 26.4 (3.32) |
| Sex: Male | 7 | 10 |
| Female | 26 | 25 |
| Weight, kg, mean (SD) | 64.05 (11.15) | 64.7 (11.29) |
| Ethnicity: | ||
| Caucasian | 24 | 24 |
| Black | 1 | 1 |
| Middle Eastern | 0 | 2 |
| Hispanic | 1 | 1 |
| East Asian | 5 | 5 |
| South Asian | 2 | 2 |
SD, standard deviation
Reported tolerability of niacin and placebo
| No effect | 0 (0) | 34 (97.1) |
| Easy to tolerate | 2 (6.1) | 1 (2.9) |
| Mildly unpleasant, but tolerable | 14 (42.4) | 0 (0) |
| Unpleasant, and difficult to tolerate | 11 (33.3) | 0 (0) |
| Intolerable, and would never take niacin again | 6 (18.2) | 0 (0) |
Adverse events reported
| Composite of pruritus (head. neck, extremities or torso): | 25 (75%) | 0 | <0.001 |
| Composite of tingling (head, torso): | 10 (30%) | 0 | <0.001 |
| Unpleasant warmth or flushing: | 33 (100%) | 1 | <0.001 |
| Nausea | 10 (30%) | 1 (3%) | .005 |
| Vomiting | 4 (12%) | 0 | .005 |
| Stomach cramps | 2 (6%) | 0 | NS |
| Vertigo | 4 (12%) | 0 | .05 |
| Difficult breathing | 2 (6%) | 0 | NS |
| Chills* | 17 (52%) | 0 | < .0001 |
| Pass stool | 3 (9%) | 0 | NS |
| Heart palpitations | 5 (15%) | 0 | .0228 |
| Other | 4 (12%) | 1 (3%) | NS |
* Chills are defined as shivering accompanied by the sensation of coldness and pallor of the skin.