Official Newsjournal of the Illinois Council of Health-System Pharmacists
by Tomasz Jurga, PharmD - Assistant Professor of Clinical Sciences, Roosevelt University College of Pharmacy
Table 1. The International Agency for Research on Cancer (IARC) Carcinogenic Classifications |
|
Classification |
Definition |
Group 1 |
Carcinogenic to humans |
Group 2A |
Probably carcinogenic to humans |
Group 2B |
Possibly carcinogenic to humans |
Group 3 |
Not classifiable as to its carcinogenicity to humans |
Group 4 |
Probably not carcinogenic to humans |
References:
1. Food and Drug Administration. Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA) (July 2018). www.fda.gov/Safety/Recalls/ucm613625.htm (accessed 2019 Jan 31).
2. Sipahi I, Debanne SM, Rowland DY, Simon DI, Fang JC. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. Lancet Oncol. 2010;11(7):627-636.
3. Angiotensin receptor blockers linked to “modest” increase in cancer risk, Lancet study reveals. The Pharmaceutical Journal. 2010;284:602.
4. Chiang YY, Chen KB, Tsai TH, Tsai WC. Lowered cancer risk with ACE inhibitors/ARBs: a population-based cohort study. J Clin Hypertens (Greenwich). 2014;16(1):27-33.
5.
Food and Drug Administration. FDA
updates on angiotensin II receptor blocker (ARB) recalls including valsartan,
losartan and irbesartan (June 2019).
fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan
(accessed 2019 June 19).
6.
Citizen Petition from Valisure, LLC (June 2019).
regulations.gov/document?D=FDA-2019-P-2869-0001 (accessed 2019 June 19).
7.
World Health Organization. International Agency
for Research on Cancer. IARC Monographs on the Identification of Carcinogenic
Hazards to Humans Preamble (2019).
monographs.iarc.fr/wp-content/uploads/2019/01/Preamble-2019.pdf
(accessed 2019 Jan 31).
8.
World Health Organization. International Agency
for Research on Cancer. Agents Classified by the IARC
Monographs, Volumes 1-123 (2018).
monographs.iarc.fr/wp-content/uploads/2018/09/List_of_Classifications.pdf (accessed
2019 Jan
31).
9. N-Nitrosodiethylamine. Pubchem Open Chemistry Database. US National Library of Medicine. pubchem.ncbi.nlm.nih.gov/compound/5921 (accessed 2019 Jan 31).
10.
N-Nitrosodimethylamine. Pubchem Open Chemistry
Database. US National Library of Medicine.
pubchem.ncbi.nlm.nih.gov/compound/6124 (accessed 2019 Jan 31).
11.
N-Methyl-N-(3-carboxypropyl)nitrosamine.
Pubchem Open Chemistry Database. US National Library of Medicine.
pubchem.ncbi.nlm.nih.gov/compound/N-Methyl-N-_3-carboxypropyl_nitrosamine (accessed
2019 June 19).
12. Liteplo RG, Meek ME, Windle WE. Concise International Chemical Assessment Document 38: N-Nitrosodimethylamine. World Health Organization. 2002.
13. US Food and Drug Administration (FDA). M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk Guidance for Industry (March 2018). www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347725.pdf (accessed 2019 Jan 31).
14. Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues (January 2019). www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629796.htm (accessed 2019 Jan 31).
15. Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345:861-869
16. Pitt B, Poole-Wilson PA, Segal R, et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial - the Losartan Heart Failure Survival Study, ELITE II. Lancet. 2000;355:1582–1587
17. Potegard A, Kristensen KB, Ernst MT, Johanses NB, Quartarolo P, Hallas J. Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study. BMJ. 2018;362:k3851.
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