Un EPF pas comme les autres

Introduction (contexte de la recherche) L'érythème pigmenté fixe (EPF) est une toxidermie médiée par les lymphocytes T CD8+. La forme habituelle se caractérise par une ou plusieurs lésions érythémateuses récidivant au même endroit avec une pigmentation résiduelle. Les atteintes muqueuses concernent 10 % des patients avec une atteinte cutanée. Les médicaments fréquemment pourvoyeurs d'EPF sont les antibiotiques, les AINS et le paracétamol. Objectif Rapporter un cas se démarquant par une atteinte de l'ensemble des lèvres rouges. Méthodes Description de cas d'un patient de 77 ans. Résultats En 2018, 15 minutes après un traitement par paracétamol, josamycine, sirop antitussif et corticoïdes par voie nasale, le patient présente un prurit labial. Le lendemain, il rapporte des lésions hyperpigmentaires diffuses des lèvres, puis 3 à 4 jours plus tard une desquamation labiale, conduisant à l'arrêt de l'ensemble des traitements. En 2020, quelques jours après le début d'un traitement ne comprenant pas de paracétamol d'après ses souvenirs, il présente un prurit des lèvres et des paupières. Le lendemain, il présente des lésions hyperpigmentaires atteignant l'ensemble des lèvres et des paupières, évoluant vers une desquamation 3 à 4 jours plus tard. En 2021, quelques jours après le début d'un traitement par paracétamol dans un contexte d'infection à COVID-19, il présente un prurit des lèvres et des paupières, avec lésions hyperpigmentaires le lendemain, et desquamation 3 à 4 jours plus tard. En novembre 2022, les IDR et patch-test au paracétamol réalisés en zone saine étaient négatifs. Au premier jour d'une réintroduction de paracétamol en décembre 2022, le patient présente une récidive avec paresthésies des lèvres et des paupières, puis hyperpigmentation des lèvres avec un discret œdème labial, lésions érosives des lèvres, et au 5e jour une desquamation des lèvres, paupières, du front et du menton d'évolution favorable sans cicatrice. Conclusions Ce cas d'EPF au paracétamol est original devant son atteinte diffuse des lèvres. En effet, il n'y a que très peu de cas rapporté d'EPF avec une telle atteinte.

RESPIR'Nantes Study: What About the Safety ?

Introduction: Remdesivir, has been evaluated in the treatment of SARS-CoV-2 pneumonia in several clinical trials, then it has been used in routine care since the European approval in this indication. Objective(s): The main objective of the RESPIR'Nantes study was to describe the clinical outcome and safety of patients treated with remdesivir in real life. We chose here to focus on safety outcomes. Method(s): To describe the safety, we considered adverse events (AEs), based on those reported to date in the Summary of Product Characteristics and potential post-marketing signals from the international pharmacovigilance database Vigilyze-. AEs were classified according to the System Organ Class (SOC) of the Medical Dictionary of Adverse Events terminology. The AEs of SOC ''hepatobiliary disorders'' and ''renal and urinary disorders'' being the most reported to date, a detailed analysis was performed Results: A total of 76 patients were included in the study from March 13 to December 31, 2020. The most common AEs were metabolism and nutrition disorders, hepatobiliary disorders, gastrointestinal disorders and renal and urinary disorders. Patients with hepatobiliary disorders had mainly include transaminases increases and 60% had pre-existing hepatobiliary disease that worsened during treatment. The median time to onset or worsening of hepatobiliary disease was one day [1-2]. It led to discontinuation of treatment in one case. Among patients with renal and urinary disorders, 50% had increased blood creatinine levels prior therapy initiation. The median time to onset or worsening of renal and urinary disorders was one day [0-16]. It led to discontinuation of treatment in two cases. Conclusion(s): A potential signal of pharmacovigilance has been identified for liver and renal disorders in Vigilyze and we have reported the expected remdesivir Aes. However, it is difficult to suspect remdesivir only without considering the pathology itself, but remdesevir appears to have favorable safety profile in patients who require minimal supplemental oxygen.

RESPIR'Nantes Study: What About the Safety ?: An International Journal of Medical Toxicology and Drug Experience

Introduction: Remdesivir, has been evaluated in the treatment of SARS-CoV-2 pneumonia in several clinical trials, then it has been used in routine care since the European approval in this indication. Objective: The main objective of the RESPIR'Nantes study was to describe the clinical outcome and safety of patients treated with remdesivir in real life. We chose here to focus on safety outcomes. Methods: To describe the safety, we considered adverse events (AEs), based on those reported to date in the Summary of Product Characteristics and potential post-marketing signals from the inter- national pharmacovigilance database Vigilyze®. AEs were classified according to the System Organ Class (SOC) of the Medical Dic- tionary of Adverse Events terminology. The AEs of SOC "hepatobiliary disorders" and "renal and urinary disorders" being the most reported to date, a detailed analysis was performed Results: A total of 76 patients were included in the study from March 13 to December 31, 2020. The most common AEs were metabolism and nutrition disorders, hepatobiliary disorders, gastrointestinal dis- orders and renal and urinary disorders. Patients with hepatobiliary disorders had mainly include transami- nases increases and 60% had pre-existing hepatobiliary disease that worsened during treatment. The median time to onset or worsening of hepatobiliary disease was one day [1-2]. It led to discontinuation of treatment in one case. Among patients with renal and urinary disor- ders, 50% had increased blood creatinine levels prior therapy initiation. The median time to onset or worsening of renal and urinary disorders was one day [0-16]. It led to discontinuation of treatment in two cases. Conclusion: A potential signal of pharmacovigilance has been identified for liver and renal disorders in Vigilyze® and we have reported the expected remdesivir Aes. However, it is difficult to suspect remdesivir only without considering the pathology itself, but remdesevir appears to have favorable safety profile in patients who require minimal supplemental oxygen.

RESPIR'Nantes study: What about the safety?

Introduction: Remdesivir has been evaluated in the treatment of SARS-CoV-2 pneumonia in several clinical trials, then it has been used in routine care since the European approval in this indication. The main objective of the RESPIR'Nantes study was to describe the clinical outcome and safety of patients treated with remdesivir in real life. We chose here to focus on safety outcomes. Material and methods: To describe the safety, we considered adverse events (AEs), based on those reported to date in the Summary of Product Characteristics and potential post-marketing signals from the international pharmacovigilance database Vigilyze®. AEs were classified according to the System Organ Class (SOC) of the Medical Dictionary of Adverse Events terminology. The AEs of SOC "hepatobiliary disorders and "renal and urinary disorders" being the most reported to date, a detailed analysis was performed. Results: A total of 76 patients were included in the study from March 13 to December 31, 2020. The most common AEs were metabolism and nutrition disorders, hepatobiliary disorders, gastrointestinal disorders and renal and urinary disorders. Patients with hepatobiliary disorders had mainly include transaminases increases and 60% had pre-existing hepatobiliary disease that worsened during treatment. The median time to onset or worsening of hepatobiliary disease was one day [1-2]. It led to discontinuation of treatment in one case. Among patients with renal and urinary disorders, 50% had increased blood creatinine levels prior therapy initiation. The median time to onset or worsening of renal and urinary disorders was one day [0-16]. It led to discontinuation of treatment in two cases. Discussion/Conclusion: A potential signal of pharmacovigilance has been identified for liver and renal disorders in Vigilyze® and we have reported the expected remdesivir AEs. However, it is difficult to suspect remdesivir only without considering the pathology itself. Remdesevir appears to have favorable safety profile in patients who require minimal supplemental oxygen.