Abstract
Background
Angiotensin II receptor blockers (ARBs) are widely used to treat hypertension and heart failure. Photosensitivity reactions are cutaneous adverse events due to exposure to a drug and either ultraviolet or visible radiation. Among the ARB class, this type of adverse drug reaction is labeled only for losartan.
Objective
The aim of this study was to provide a descriptive evaluation of photosensitivity reports with ARBs in the World Health Organization Global Individual Case Safety Report database, VigiBase®.
Methods
All reports of photosensitivity reported with ARBs were identified from VigiBase®. All variables contained in the reports were analyzed. Information component (IC) and its lower limit of a 95 % credibility interval (IC025) values were considered as measures of disproportionality for the assessment of photosensitivity cases reported with ARBs. VigiGrade completeness score (C) was used as a measure of quality of each report. Well-documented reports (C > 0.8) were fully described and analyzed.
Results
Up to December 2014, a total of 203 reports on photosensitivity reported with ARBs and submitted by 25 different countries had been recorded in VigiBase®. Among them, 25.1 % involved losartan, 23.1 % involved irbesartan, and 21.7 % involved valsartan. In 126 cases, the ARB was the only suspected drug and in 10 % of them the reaction was serious. IC and IC025 values indicated a possible positive correlation between photosensitivity and both irbersartan and losartan. A focus on well-documented reports, after excluding those with a co-prescription of other drugs known to cause photosensitivity, showed that out of 18 cases, six were related to losartan, four to olmesartan, three to irbesartan, two to valsartan and to candesartan, and one to telmisartan. Causality assessment was ‘probable’ in ten cases and ‘possible’ in eight cases. Moreover, positive dechallenge was reported in ten cases and positive rechallenge in one case.
Conclusions
Photosensitivity reactions have been reported with almost all ARBs in VigiBase® with a positive disproportionality for irbesartan and losartan. Considering that ARBs share the same chemical structure, which may have the same response to sunlight, it is plausible to consider photosensitivity as a possible class effect. Physicians and patients should be aware of potentially serious photosensitivity reactions related to treatment with ARBs.
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References
Drucker AM, Rosen CF. Drug-induced photosensitivity: culprit drugs, management and prevention. Drug Saf. 2011;34(10):821–37.
Moore DE. Drug-induced cutaneous photosensitivity: incidence, mechanism, prevention and management. Drug Saf. 2002;25(5):345–72.
Verdel BM, Souverein PC, Meyboom RH, Kardaun SH, Leufkens HG, Egberts AC. Risk of drug-induced photosensitivity: focus on spectroscopic and molecular characteristics. Pharmacoepidemiol Drug Saf. 2009;18(7):602–9. doi:10.1002/pds.1760.
Ciocca M. Medication and supplement use by athletes. Clin Sports Med. 2005;24(3):719–38.
Diaz JH, Nesbitt LT Jr. Sun exposure behavior and protection: recommendations for travelers. J Travel Med. 2013;20(2):108–18.
Dawe RS, Ibbotson SH. Drug-induced photosensitivity. Dermatol Clin. 2014;32(3):363–8.
National Library of Medicine. DailyMed. Available at: http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed 2015 Mar 04.
Agenzia Italiana del farmaco. Banca dati farmaci. Available from http://farmaci.agenziafarmaco.gov.it/bancadatifarmaci. Accessed 2015 Mar 04.
Datapharm Communications Limited. Electronic medicines compendium. Available at: http://www.mhra.gov.uk/Safetyinformation/Medicinesinformation/SPCandPILs/index.htm. Accessed 2015 March 04.
The evidence-based resources of Micromedex® Solutions. Drug: detailed evidence-based information (DRUGDEX®). Available from http://www.micromedexsolutions.com. Accessed 2014 July 10.
Frye CB, Pettigrew TJ. Angioedema and photosensitive rash induced by valsartan. Pharmacotherapy. 1998;18(4):866–8.
World Health Organization. VigiBase® the WHO Global ICSR database system. Available from http://who-umc.org/DynPage.aspx?id=98082&mn1=7347&mn2=7252&mn3=7322&mn4=7326.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000;356(9237):1255–59.
Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998;54(4):315–21.
Bergvall T, Norén GN, Lindquist M. vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf. 2014;37(1):65–77.
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–45.
Goncalo M. Phototoxic and photoallergic reactions. In: Johansen JD, et al., editors. Contact dermatitis. Berlin Heidelberg: Springer Verlag; 2010.
Hazell L, Shakir SA. Underreporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.
Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19–31.
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The opinions expressed by the authors in this article are personal and may not be construed or reported as those of the WHO.
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No sources of funding were used to assist in the preparation of this study.
Conflicts of Interest
Ermelinda Viola, Anna Coggiola Pittoni, Agnes Drahos, Ugo Moretti, and Anita Conforti have no conflicts of interest that are directly relevant to the content of this study.
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Viola, E., Coggiola Pittoni, A., Drahos, A. et al. Photosensitivity with Angiotensin II Receptor Blockers: A Retrospective Study Using Data from VigiBase® . Drug Saf 38, 889–894 (2015). https://doi.org/10.1007/s40264-015-0323-7
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DOI: https://doi.org/10.1007/s40264-015-0323-7