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Mangels, Corinna (2012): Unerwünschte Arzneimittelwirkungen bei der Anwendung von Cyclosporin A (Atopica®) bei Hund und Katze. Dissertation, LMU München: Faculty of Veterinary Medicine
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Abstract

The aim of the present study was the analysis of all ADRs reported to the spontaneous reporting system of the German Pharmacovigilance Database. One main focus was on the detection of so far unknown, rare or serious events. In addition, statistical analysis was used to reveal potential risk factors for the respective ADRs. In a final step all ADRs reported to the PhV-database were compared to the real incidences of a control group. The German Pharmacovigilance database contained 294 case reports of CyA-related ADRs during a 6 year period after the introduction of Atopica® into veterinary medicine that were compared to 54 cases observed at the Clinic of Small Animal Medicine of the University of Munich, Germany. The survey showed that during this time period CyA/Atopica® was used for a number of off-label indications and at a wide dosing range. The incidence rates of commonly known CyA-associated ADRs in the medical database were as follows: emesis (54%), diarrhoea (48%), verruciform lesions of the skin (22%), anorexia (22 %), and gingival hyperplasia (7%). The pharmacovigilance database revealed the existence of a broad spectrum of rare drug events not stated in the package leaflet of Atopica®, including abnormal test results (39%), neoplasms (23%), cardiovascular disorders (14%), haematological disorders (13%), diabetes mellitus (10%), weight loss (7%), allergic diseases (7%), lethargy/hyperactivity (5%), and muscle disorders (3%). The statistical analysis revealed a significant influence of the co-medication of ketoconazole and the development of tumours possibly due to an increase of the blood level of cyclosporine. Furthermore, an increased risk for disorders in glucose metabolism or even for the development of diabetes mellitus was observed when glucocorticoids were administered concurrently to the patient. These results suggest that despite its availability as a licensed drug, long-term use of CyA in routine veterinary practice is associated with a high frequency of common ADRs and a remarkable number of less frequently observed drug events that requires careful prescription and continued surveillance of the patients