Czy suplementy diety to leki? Artykuł przeglądowy
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Opublikowane:
cze 30, 2020
Słowa kluczowe:
lek recepturowy, lek bez recepty, suplement diety
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Abstrakt
Suplementy diety nie są lekami bez recepty (OTC) i w przeciwieństwie do leków na receptę i OTC nie ma konieczności wykazania ich skuteczności i/lub bezpieczeństwa przed wprowadzeniem do obrotu. Niestety, pacjenci, farmaceuci, a nawet pracownicy służby zdrowia mogą błędnie uznawać leki OTC oraz suplementy za równoważne. Ponadto mogą odnosić mylne wrażenie, że suplementy diety podlegają takim samym lub podobnym, rygorystycznym normom bezpieczeństwa, skuteczności i dobrych praktyk wytwarzania wymaganym w przypadku leków OTC.
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Jak cytować
Postuła, M. (2020). Czy suplementy diety to leki? . Medycyna Faktów , 13(2(47), 174-177. https://doi.org/10.24292/01.MF.0220.5
Numer
Dział
Artykuły
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Bibliografia
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2. Miller E, Pastor-Barriero R. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005; 142: 37-46.
3. Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994; 330: 1029-35.
4. Omenn G, Goodman G, Thornquist M et al. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med. 1996; 334: 1150-5.
5. Feskanich D, Singh V, Willett W et al. Dense low density lipoprotein subspecies with diminished oxidative resistance pre-dominate in combined hyperlipidemia. JAMA. 2002; 287: 47-54.
6. Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, US Food and Drug Administration. Letter responding to a request to reconsider the qualified claim for a dietary supplement health claim for omega-3 fatty acids and coronary heart disease. Docket No. 91N-0103.
7. FDA/CFSAN. Dietary Supplement Health and Education Act of 1994. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, December 1, 1995 (Access: 20.03.2020).
8. Kris-Etherton P, Harris W, Appel L, American Heart Association (AHA), AHA Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002; 106: 2747-57.
9. European Food Safety Authority. Food supplements (Access: 20.03.2020).
10. Food and Drug Administration Center for Drug Evaluation and Research (Access: 20.03.2020).
11. Dietary Supplement Health and Education Act of 1994 (Access: 20.03.2020).
12. Cohen PA. Hazards of hindsight–monitoring the safety of nutritional supplements. N Engl J Med. 2014; 370: 1277-80.
13. American Cancer Society. Dietary supplements: what is safe? (Access: 20.03.2020).
14. Dietary supplements: what you need to know (Access: 20.03.2020).
15. Tucker J, Fischer T, Upjohn L et al. Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings. JAMA Netw Open. 2018; 1: e183337.
16. Harel Z, Harel S, Wald R et al. The frequency and characteristics of dietary supplement recalls in the United States. JAMA Intern Med. 2013; 173: 926-8.
2. Miller E, Pastor-Barriero R. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005; 142: 37-46.
3. Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994; 330: 1029-35.
4. Omenn G, Goodman G, Thornquist M et al. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med. 1996; 334: 1150-5.
5. Feskanich D, Singh V, Willett W et al. Dense low density lipoprotein subspecies with diminished oxidative resistance pre-dominate in combined hyperlipidemia. JAMA. 2002; 287: 47-54.
6. Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, US Food and Drug Administration. Letter responding to a request to reconsider the qualified claim for a dietary supplement health claim for omega-3 fatty acids and coronary heart disease. Docket No. 91N-0103.
7. FDA/CFSAN. Dietary Supplement Health and Education Act of 1994. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, December 1, 1995 (Access: 20.03.2020).
8. Kris-Etherton P, Harris W, Appel L, American Heart Association (AHA), AHA Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation. 2002; 106: 2747-57.
9. European Food Safety Authority. Food supplements (Access: 20.03.2020).
10. Food and Drug Administration Center for Drug Evaluation and Research (Access: 20.03.2020).
11. Dietary Supplement Health and Education Act of 1994 (Access: 20.03.2020).
12. Cohen PA. Hazards of hindsight–monitoring the safety of nutritional supplements. N Engl J Med. 2014; 370: 1277-80.
13. American Cancer Society. Dietary supplements: what is safe? (Access: 20.03.2020).
14. Dietary supplements: what you need to know (Access: 20.03.2020).
15. Tucker J, Fischer T, Upjohn L et al. Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings. JAMA Netw Open. 2018; 1: e183337.
16. Harel Z, Harel S, Wald R et al. The frequency and characteristics of dietary supplement recalls in the United States. JAMA Intern Med. 2013; 173: 926-8.