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Original research

Safety profile of D-penicillamine: a comprehensive pharmacovigilance analysis by FDA adverse event reporting system

ORCID Icon, ORCID Icon, , &
Pages 1443-1450 | Received 12 Mar 2021, Accepted 13 Jul 2021, Published online: 26 Jul 2021

References

  • Kim JJ, Kim YS, Kumar V. Heavy metal toxicity: an update of chelating therapeutic strategies. J Trace Elem Med Biol. 2019 July;54:226–231.
  • Friedman M. Chemical basis for pharmacological and therapeutic actions of penicillamine. Proc R Soc Med. 1977;70 Suppl 3(Suppl3):50–60.
  • Ferenci P. Regional distribution of mutations of the ATP7B gene in patients with Wilson disease: impact on genetic testing. Hum Genet. 2006 Sept;120(2):151–159.
  • Czlonkowska A, Litwin T, Dusek P, et al. Wilson disease. Nat Rev Dis Primers. 2018 Sept 6;4(1):21.
  • Roberts EA. Update on the diagnosis and management of Wilson disease. Curr Gastroenterol Rep. 2018 Nov 5;20(12):56.
  • Kalita J, Kumar V, Misra UK. A study on apoptosis and anti-apoptotic status in Wilson disease. Mol Neurobiol. 2016 Dec;53(10):6659–6667.
  • Ranjan A, Kalita J, Kumar V, et al. MRI and oxidative stress markers in neurological worsening of Wilson disease following penicillamine. Neurotoxicology. 2015 July;49:45–49.
  • Nagasaka H, Takayanagi M, Tsukahara H. Children’s toxicology from bench to bed–Liver Injury (3): oxidative stress and anti-oxidant systems in liver of patients with Wilson disease. J Toxicol Sci. 2009;34(Suppl 2):SP229–36.
  • Kumar V, Kalita J, Bora HK, et al. Temporal kinetics of organ damage in copper toxicity: a histopathological correlation in rat model. Regul Toxicol Pharmacol. 2016 Nov;81:372–380.
  • Litwin T, Dziezyc K, Czlonkowska A. Wilson disease-treatment perspectives. Ann Transl Med. 2019 Apr;7(Suppl 2):S68.
  • European Association for Study of L. EASL Clinical Practice Guidelines: wilson’s disease. J Hepatol. 2012 Mar;56(3):671–685.
  • Michael S, Karl Heinz W. Wilson disease: pathogenesis, molecular mechanisms, diagnosis, treatment and monitoring. Undetermined. 2019.
  • Pfeiffer RF. Wilson’s Disease. Semin Neurol. 2007 Apr;27(2):123–132.
  • Lorincz MT. Neurologic Wilson’s disease. Ann N Y Acad Sci. 2010 Jan;1184:173–187.
  • Wiggelinkhuizen M, Tilanus ME, Bollen CW, et al. Systematic review: clinical efficacy of chelator agents and zinc in the initial treatment of Wilson disease. Aliment Pharmacol Ther. 2009 May 1;29(9):947–958.
  • Roberts EA, Schilsky ML. American Association for Study of Liver D. Diagnosis and treatment of Wilson disease: an update. Hepatology. 2008 June;47(6):2089–2111.
  • Czlonkowska A, Litwin T, Karlinski M, et al. D-penicillamine versus zinc sulfate as first-line therapy for Wilson’s disease. Eur J Neurol. 2014 Apr;21(4):599–606.
  • Weiss KH, Gotthardt DN, Klemm D, et al. Zinc monotherapy is not as effective as chelating agents in treatment of Wilson disease. Gastroenterology. 2011 Apr;140(4):1189–1198 e1.
  • Weiss KH, Thurik F, Gotthardt DN, et al. Efficacy and safety of oral chelators in treatment of patients with Wilson disease. Clin Gastroenterol Hepatol. 2013 Aug;11(8):1028–35 e1-2.
  • Eggermann T, Venghaus A, Zerres K. Cystinuria: an inborn cause of urolithiasis. Orphanet J Rare Dis. 2012 Apr 5;7(1):19.
  • Chillaron J, Font-Llitjos M, Fort J, et al. Pathophysiology and treatment of cystinuria. Nat Rev Nephrol. 2010 July;6(7):424–434.
  • DeBerardinis RJ, Coughlin CR 2nd, Kaplan P. Penicillamine therapy for pediatric cystinuria: experience from a cohort of American children. J Urol. 2008 Dec;180(6):2620–2623.
  • Halperin EC, Thier SO, Rosenberg LE. The use of D-penicillamine in cystinuria: efficacy and untoward reactions. Yale J Biol Med. 1981 Nov-Dec;54(6):439–446.
  • Guo Q, Wang Y, Xu D, et al. Rheumatoid arthritis: pathological mechanisms and modern pharmacologic therapies. Bone Res. 2018 Apr 27;6(1):15.
  • Smolen JS, Aletaha D, Barton A, et al. Rheumatoid arthritis. Nat Rev Dis Primers. 2018 Feb 8;4(1):18001.
  • McInnes IB, Schett G. Pathogenetic insights from the treatment of rheumatoid arthritis. Lancet. 2017 June 10;389(10086):2328–2337.
  • Taylor HG, Samanta A. Penicillamine in rheumatoid arthritis. A problem of toxicity. Drug Saf. 1992 Jan-Feb;7(1):46–53.
  • Suarez-Almazor ME, Spooner C, Belseck E. Penicillamine for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2000;4:CD001460.
  • Steen VD, Medsger TA Jr., Rodnan GP. D-Penicillamine therapy in progressive systemic sclerosis (scleroderma): a retrospective analysis. Ann Intern Med. 1982 Nov;97(5):652–659.
  • Blanusa M, Varnai VM, Piasek M, et al. Chelators as antidotes of metal toxicity: therapeutic and experimental aspects. Curr Med Chem. 2005;12(23):2771–2794.
  • FDA US. U.S. Food & Drug Administration. Penicillamine Drugs@FDA: FDA-approved drugs. 1970 [Cited 2020 Jul 31]. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019853
  • Böhm R, von Hehn L, Herdegen T, et al. OpenVigil FDA–inspection of US American adverse drug events pharmacovigilance data and novel clinical applications. PloS one. 2016;11(6):e0157753.
  • Böhm R, Höcker J, Cascorbi I, et al. OpenVigil—free eyeballs on AERS pharmacovigilance data. PloS one. 2012;30(2):137–138.
  • Meng L, Huang J, Jia Y, et al. Assessing fluoroquinolone-associated aortic aneurysm and dissection: data mining of the public version of the FDA adverse event reporting system. Int J Clin Pract. 2019 May;73(5):e13331.
  • Huang J, Meng L, Yang B, et al. Safety profile of epidermal growth factor receptor tyrosine kinase inhibitors: a disproportionality analysis of FDA adverse event reporting system. Sci Rep. 2020 Mar 16;10(1):4803.
  • Singh AP, Tousif S, Umbarkar P, et al. A pharmacovigilance study of hydroxychloroquine cardiac safety profile: potential implication in COVID-19 mitigation. J Clin Med. 2020 June 15;9(6):1867.
  • Chen C, Chen H, Zhang Y, et al. TBtools: an integrative toolkit developed for interactive analyses of big biological data. Mol Plant. 2020 Aug 3;13(8):1194–1202.
  • Sakaeda T, Tamon A, Kadoyama K, et al. Data mining of the public version of the FDA adverse event reporting system [Review]. Int J Med Sci. 2013;10(7):796–803.
  • Bate A, Evans SJ. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009 June;18(6):427–436.
  • Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001 Oct-Nov;10(6):483–486.
  • Svetel M, Kozic D, Stefanova E, et al. Dystonia in Wilson’s disease. Mov Disord. 2001 July;16(4):719–723.
  • Kalita J, Kumar V, Misra UK, et al. Movement disorder in Wilson disease: correlation with mri and biomarkers of cell injury. J Mol Neurosci. 2021 Feb;71(2):338–346.
  • Kalita J, Kumar V, Chandra S, et al. Worsening of Wilson disease following penicillamine therapy. Eur Neurol. 2014;71(3–4):126–131.
  • Czlonkowska A, Litwin T, Chabik G. Wilson disease: neurologic features. Handb Clin Neurol. 2017;142:101–119.
  • Litwin T, Dziezyc K, Karlinski M, et al. Early neurological worsening in patients with Wilson’s disease. J Neurol Sci. 2015 Aug 15;355(1–2):162–167.
  • De Fabregues O, Vinas J, Palasi A, et al. Ammonium tetrathiomolybdate in the decoppering phase treatment of Wilson’s disease with neurological symptoms: a case series. Brain Behav. 2020 May;10(5):e01596.
  • Litwin T, Gromadzka G, Czlonkowska A, et al. The effect of gender on brain MRI pathology in Wilson’s disease. Metab Brain Dis. 2013 Mar;28(1):69–75.
  • Członkowska A, Dzieżyc-Jaworska K, Kłysz B, et al. Difficulties in diagnosis and treatment of Wilson disease—a case series of five patients. Ann Trans Med. 2019;2019:19.
  • Dahlberg PJ, Van Den B, Kurtz SB, et al. Clinical features and management of cystinuria. Mayo Clin Proc. 1977 Sept;52(9):533–542.
  • Chow GK, Streem SB. Medical treatment of cystinuria: results of contemporary clinical practice. J Urol. 1996 Nov;156(5):1576–1578.
  • Crawhall JC. Cystinuria–an experience in management over 18 years. Miner Electrolyte Metab. 1987;13(4):286–293.
  • Stephens AD. Cystinuria and its treatment: 25 years experience at St. Bartholomew’s Hospital. J Inherit Metab Dis. 1989;12(2):197–209.
  • Dello Strologo L, Laurenzi C, Legato A, et al. Cystinuria in children and young adults: success of monitoring free-cystine urine levels. Pediatr Nephrol. 2007 Nov;22(11):1869–1873.
  • Pareek G, Steele TH, Nakada SY. Urological intervention in patients with cystinuria is decreased with medical compliance. J Urol. 2005 Dec;174(6):2250–2, discussion 2252.
  • Pak CY, Fuller C, Sakhaee K, et al. Management of cystine nephrolithiasis with alpha-mercaptopropionylglycine. J Urol. 1986 Nov;136(5):1003–1008.
  • Lindell A, Denneberg T, Granerus G. Studies on renal function in patients with cystinuria. Nephron. 1997;77(1):76–85.
  • Asanuma H, Nakai H, Takeda M, et al. Clinical study on cystinuria in children–the stone management and the prevention of calculi recurrence. Nihon Hinyokika Gakkai zasshi Jan J Urol. 1998 Sept;89(9):758–765.
  • Lipsky PE. Studies on the mechanism of action of D-penicillamine in rheumatoid arthritis. In: Yoshida H, Hagihara Y, Ebashi S, editors. Biochemical immunological pharmacology. Pergamon; 1982. p. 181–191.
  • Stein HB, Patterson AC, Offer RC, et al. Adverse effects of D-penicillamine in rheumatoid arthritis. Ann Intern Med. 1980 Jan;92(1):24–29.
  • Appenzeller-Herzog C, Mathes T, Heeres MLS, et al. Comparative effectiveness of common therapies for Wilson disease: a systematic review and meta-analysis of controlled studies. Liver Int. 2019 Nov;39(11):2136–2152.
  • Jaffe IA. Induction of auto-immune syndromes by penicillamine therapy in rheumatoid arthritis and other diseases. Springer Semin Immunopathol. 1981 June 1;4(2):193–207.
  • Suarez-Almazor ME, Spooner C, Belseck E. Penicillamine for rheumatoid arthritis. Cochrane Database Syst Rev. 2000;2:CD001460.

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