Artikel
Melanoma reported as an adverse drug reaction
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Autoren
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Bernhardt Sachs
- Federal Institute for Drugs and Medical Devices, Bonn, Germany; Department for Dermatology and Allergy, University Hospital Aachen, Aachen, Germany
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Diana Dubrall
- Federal Institute for Drugs and Medical Devices, Bonn, Germany; Institute for Medical Biometry, Informatics and Epidemiology, University Hospital of Bonn, Bonn, Germany
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Klaus Kraywinkel
- Robert Koch Institute, Berlin, Germany
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Maike Schulz
- Central Research Institute of Ambulatory Health Care in Germany, Berlin, Germany
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Matthias Schmid
- Institute for Medical Biometry, Informatics and Epidemiology, University Hospital of Bonn, Bonn, Germany
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Jens Bäte
- Federal Institute for Drugs and Medical Devices, Bonn, Germany
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Wilma Fischer-Barth
- Federal Institute for Drugs and Medical Devices, Bonn, Germany
| Veröffentlicht: | 10. November 2021 |
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Gliederung
Text
Background: Melanoma accounts for the majority of skin cancer deaths. Its main environmental risk factor is ultraviolet light radiation. Further downstream, the elimination of neoplastic melanocytes by the immune system is of importance. The occurrence of melanoma associated with drug therapy has been described in literature. The first objective of this study was to analyse a large number of validated spontaneous adverse drug reaction (ADR) reports of melanoma with regard to their suspected drugs and reported characteristics. The second objective was to compare these characteristics to those of melanomas occurring in the general population. Here, we present first results of the analysis.
Materials and Methods: We identified spontaneous ADR reports of melanoma originating from Germany in a large ADR database (EudraVigilance) and analyzed them with regard to the aforementioned aspects. We then compared the results with an analyses of melanoma cases from the German cancer registries.
Results: Immunosuppressants dominated among the ten drugs most frequently suspected in the melanoma ADR reports. Over all reports, the median time to onset of melanoma diagnosis was only 2.0 years. The patients in the ADR reports of melanoma were substantially younger than melanoma patients of the cancer registries.
Conclusion: As a clinical translation of our findings, physicians treating patients with immunosuppressants should be aware that melanoma may occur at younger ages in these patients and may manifest within two years after initiating therapy. This underlines the importance of regular dermatological examinations of patients being treated with immunosuppressants.
