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Nango D, Hirose Y, Goto M, et al. Analysis of the Association of Administration of various glucocorticoids with development of acute pancreatitis using US Food and Drug Administration adverse event reporting system (FAERS). J Pharm Health Care Sci. 2019;5:5doi: 10.1186/s40780-019-0134-6.
Nango, D., Hirose, Y., Goto, M., & Echizen, H. (2019). Analysis of the Association of Administration of various glucocorticoids with development of acute pancreatitis using US Food and Drug Administration adverse event reporting system (FAERS). Journal of pharmaceutical health care and sciences, 55. https://doi.org/10.1186/s40780-019-0134-6
Nango, Daisuke, et al. "Analysis of the Association of Administration of various glucocorticoids with development of acute pancreatitis using US Food and Drug Administration adverse event reporting system (FAERS)." Journal of pharmaceutical health care and sciences vol. 5 (2019): 5. doi: https://doi.org/10.1186/s40780-019-0134-6
Nango D, Hirose Y, Goto M, Echizen H. Analysis of the Association of Administration of various glucocorticoids with development of acute pancreatitis using US Food and Drug Administration adverse event reporting system (FAERS). J Pharm Health Care Sci. 2019 Feb 28;5:5. doi: 10.1186/s40780-019-0134-6. eCollection 2019. PMID: 30858980; PMCID: PMC6394067.
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J Pharm Health Care Sci. 2019 Feb 28;5:5. doi: 10.1186/s40780-019-0134-6. eCollection 2019.

Analysis of the Association of Administration of various glucocorticoids with development of acute pancreatitis using US Food and Drug Administration adverse event reporting system (FAERS).

Journal of pharmaceutical health care and sciences

Daisuke Nango, Yukifumi Hirose, Makoto Goto, Hirotoshi Echizen

Affiliations

  1. Departments of Pharmacy, Shin-Yurigaoka General Hospital, 255 Furusawa-tsuko, Asao-ku, Kawasaki, Kanagawa 215-0026 Japan.
  2. 3Department of Pharmacotherapy, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose, Tokyo, 204-8588 Japan.
  3. Kyoto Constella Technologies Co., Ltd., 4th Floor, Kyozome Kaikan, 481 Tourouyama-cho, Nakagyo-ku, Kyoto, 604-8225 Japan.

PMID: 30858980 PMCID: PMC6394067 DOI: 10.1186/s40780-019-0134-6

Abstract

BACKGROUND: There have been debates about the association between the administration of glucocorticoids and the development of acute pancreatitis, since many anecdotal cases of this adverse event were affected either by concomitant diseases (such as systemic lupus erythematosus, SLE) that may develop acute pancreatitis without glucocorticoid treatment or by co-administered drugs with high risk for the event. The aim of the present study was to explore whether disproportionally elevated signals of developing acute pancreatitis may be detected in patients receiving glucocorticoids as compared those receiving other drugs.

METHODS: We retrieved spontaneously reported cases of acute pancreatitis and clinically related adverse events (target events) from the US Food and Drug Administration Adverse Event Reporting System (FAERS) using 18 preferred terms (PTs). Target drugs studied were cortisol, cortisone, prednisolone, methylprednisolone, triamcinolone, dexamethasone, and betamethasone. After cleaning the data, we calculated reporting odds ratios (RORs) and 95% confidence intervals (CIs) of acute pancreatitis in patients who received one of the glucocorticoids. RORs were calculated for each glucocorticoid using all reported cases irrespective of reporters' judgement about the contribution of the target drugs to events [i.e., primary suspected medication (PS), secondary suspected medication (SS), concomitant medication (C) and interacting (I)] and using cases with higher certainty of contribution (PS and SS), separately. When the lower limit of 95% CI of a ROR signal exceeded 1.0, the signal was considered statistically significant.

RESULTS: The RORs (95% CIs) calculated using all reported cases (PS, SS, C, and I) for cortisol (1.68; 1.43-1.98), prednisolone (1.33; 1.19-1.47), methylprednisolone (1.77; 1.55-2.02) were significant, whereas those for other target drugs were insignificant. Using the cases in which target drugs were considered to contribute the events with higher certainty (PS or SS), RORs for prednisolone (1.31; 1.10-1.55), methylprednisolone (1.62; 1.30-2.01), and dexamethasone (1.27; 1.10-1.47) were considered significant, whereas those for others were insignificant. Regarding the performance of PTs for detecting signals (RORs) associated with acute pancreatitis from FAERS database, "pancreatitis acute" gave RORs with higher significance than others, whereas more specific PTs, "haemorrhagic necrotic pancreatitis", "ischaemic pancreatitis", "pancreatic necrosis" and "pancreatitis necrotising", gave RORs with greater magnitude.

CONCLUSION: The present study demonstrated that the overrepresentation of signals for acute pancreatitis may be detected for prednisolone, methylprednisolone, and some others in the FAERS database.(372 words).

Keywords: Acute pancreatitis; FAERS; Glucocorticoids; Reported odds ratio (ROR)

Conflict of interest statement

Ethical approval was not sought because the study involved only analysis of data obtained from a public database. Informed consent to participate: not applicable.Not applicable.The authors declare tha

References

  1. Dermatology. 1999;198(3):304-6 - PubMed
  2. Eur J Clin Pharmacol. 2001 Sep;57(6-7):517-21 - PubMed
  3. Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):483-6 - PubMed
  4. Pharmacoepidemiol Drug Saf. 2002 Jan-Feb;11(1):3-10 - PubMed
  5. J Gastroenterol Hepatol. 2003 Sep;18(9):1110-1 - PubMed
  6. Pancreas. 2003 Nov;27(4):286-90 - PubMed
  7. Hepatogastroenterology. 1992 Dec;39(6):533-5 - PubMed
  8. Pancreatology. 2004;4(1):42-8 - PubMed
  9. Pharmacoepidemiol Drug Saf. 2004 Aug;13(8):519-23 - PubMed
  10. Clin Gastroenterol Hepatol. 2007 Jun;5(6):648-61; quiz 644 - PubMed
  11. Ann Epidemiol. 2007 Jul;17(7):491-7 - PubMed
  12. Nihon Jinzo Gakkai Shi. 2008;50(7):948-53 - PubMed
  13. J Rheumatol. 2010 Feb;37(2):341-5 - PubMed
  14. JOP. 2011 May 06;12(3):250-4 - PubMed
  15. Br J Clin Pharmacol. 2011 Dec;72(6):905-8 - PubMed
  16. JAMA Intern Med. 2013 Mar 25;173(6):444-9 - PubMed
  17. J Pharmacol Pharmacother. 2013 Dec;4(Suppl 1):S66-72 - PubMed
  18. Rinsho Ketsueki. 2014 May;55(5):552-7 - PubMed
  19. Ochsner J. 2015 Spring;15(1):45-51 - PubMed
  20. BMJ Case Rep. 2015 Jul 06;2015:null - PubMed
  21. Arch Intern Med. 1978 Nov;138(11):1726 - PubMed
  22. J Pharm Health Care Sci. 2018 May 31;4:14 - PubMed
  23. Mayo Clin Proc. 1988 May;63(5):466-73 - PubMed
  24. Naika. 1969 May;23(5):915-20 - PubMed
  25. Arthritis Rheum. 1982 Aug;25(8):1006-9 - PubMed
  26. Clin Exp Rheumatol. 1983 Oct-Dec;1(4):345-7 - PubMed
  27. Semin Arthritis Rheum. 1980 May;9(4):237-47 - PubMed
  28. Am J Med Sci. 1978 Sep-Oct;276(2):211-9 - PubMed
  29. Am J Gastroenterol. 1995 Dec;90(12):2134-9 - PubMed
  30. Ann Intern Med. 1996 Jun 1;124(11):1016 - PubMed
  31. Pancreas. 1996 Jul;13(1):100-9 - PubMed

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