Descriptive analysis of 179 German reports of melanoma reported to an adverse drug reaction database as a drug-related adverse effect, and comparison with melanoma cases contained in German cancer registries

Background: Malignant melanoma (MM) is one of the most aggressive forms of skin cancer. The occurrence of MM associated with drug therapy has been described in the literature. However, there is no analysis of a substantial number of validated reports of drug-associated MM. Aim: To analyse a substantial number of validated spontaneous reports of drug-associated MM with regard to the suspected drug and the reported characteristics, and to compare these analyses with those of MM cases occurring in the general population in Germany. Methods: Spontaneous reports of MM associated with drug therapy in Germany were identified in a large adverse drug reaction database (EudraVigilance). These results were then compared with analyses of MMs in the pooled data from a population-based German cancer registry. Results: The 10 most frequently suspected drugs in the MM reports all target the immune system, with 7 of these being immunosuppressants. The median time to onset to MM diagnosis was 2.0 years. Patients with drug-associated MM were 11 years (median) younger than patients with MM in the cancer registry, and this age difference was greater for female than for male patients. Conclusions: Our results emphasize the importance of regular dermatological examinations of patients being treated with immunosuppressants. Physicians should be aware that in these patients, MM might be detected at younger ages and even within 2 years after initiating therapy.Peer Reviewe

Stevens-Johnson-Syndrom und toxisch epidermale Nekrolyse – Anforderungen an die Produktinformationen

Die schweren arzneimittelinduzierten Hautreaktionen Stevens-Johnson-Syndrom und toxisch epidermale Nekrolyse sind potenziell lebensbedrohliche Krankheitsbilder, deren Prognose von der frühzeitigen Diagnose und dem Zeitpunkt des Absetzens des auslösenden Arzneimittels bestimmt wird. Für 14 Wirkstoffe wurde ein eindeutig erhöhtes Risiko des Auftretens dieser Hautreaktionen identifiziert. Da dieses Risiko in den Produktinformationen dieser Wirkstoffe in den EU-Mitgliedsstaaten nicht einheitlich und zum Teil nicht adäquat beschrieben ist, wurden auf europäischer Ebene einheitliche Kernaussagen für die entsprechenden Produktinformationen erarbeitet

Isotretinoin und Teratogenität: Konsequenzen für die klinische Anwendung

Isotretinoin verfügt über ein ausgeprägtes teratogenes Potenzial. Aufgrund der Anwendung bei schweren, auf andere Therapien nicht ansprechende Formen der Akne werden häufig jüngere Erwachsene behandelt.1 Um das Risiko des Auftretens von Schwangerschaften unter Anwendung von Isotretinoin und das damit verbundene Risiko von Missbildungen zu minimieren, sind besondere Sicherheitsmaßnahmen erforderlich, die in einem Schwangerschaftsverhütungsprogramm zusammengefasst sind. Die Auflagen dieses Programms sind bei der Anwendung von Isotretinoin unbedingt einzuhalten

Pharmakogenetik schwerwiegender kutaner Überempfindlichkeitsreaktionen auf Arzneimittel: Konsequenzen für die Produktinformationen?

Schwerwiegende kutane Überempfindlichkeitsreaktionen auf Arzneimittel, wie die toxisch epidermale Nekrolyse oder das DRESS-Syndrom, sind potenziell lebensbedrohliche Krankheitsbilder. In den letzten Jahren wurden innerhalb bestimmter Populationen HLA-Assoziationen für durch bestimmte Wirkstoffe ausgelöste Überempfindlichkeitsreaktionen gezeigt. Der folgende Artikel gibt einen Überblick über relevante Assoziationen und regulatorische Konsequenzen

Analyses of Basal and Squamous Cell Carcinoma Reported as an Adverse Drug Reaction and Comparison with Cases from the Cancer Registry from Germany

INTRODUCTION: In Germany, incidence rates of basal cell (BCC) and squamous cell carcinoma (SCC) rose significantly from 1998 to 2010. Ultraviolet (UV) light exposure, immunosuppressants and drugs with photosensitising potential are known to increase the risk to develop BCC and SCC. The aim of our study was to analyse the adverse drug reaction (ADR) reports from Germany referring to BCC and SCC and to compare them to BCC and SCC occurring in the general population. METHODS: We analysed all validated spontaneous ADR reports referring to BCC (n = 191) and SCC (n = 75) from Germany contained in the European ADR database EudraVigilance prior to 6 March 2019. These reports were compared to 1,267,210 BCC and 476,903 SCC cases from the German Centre for Cancer Registry Data recorded from 2006 to 2018. RESULTS: The number of BCC and SCC reports as well as the BCC and SCC incidences in the registry increased in the analysed time period. Patients with drug-associated BCC (60 years) and SCC (64 years) were younger than patients with BCC (72 years) and SCC (76 years) in the registry. In 57.1 and 60.0% of BCC and SCC reports immunosuppressants were reported as suspected. The reported suspected drug was assumed to possess a photosensitising potential in 41.9 and 44.0% of BCC and SCC reports. CONCLUSIONS: In Germany, drug-associated BCC and SCC occurred at a younger age than in the general population. The results underline the necessity for skin cancer screening of patients treated with immunosuppressants or with drugs with photosensitising potential