| アブストラクト | INTRODUCTION: Acquired hemophilia A (AHA) is a rare autoimmune hemorrhagic disease occurring in several underlying conditions. Drug-associated AHA (D-AHA) is poorly addressed nowadays. AIM: This work aims to identify and characterize which drugs are associated with AHA using the WHO global database of reported potential effects of medicinal products (VigiBase). METHODS: First, we realized a disproportionality analysis using the information component (IC) to identify D-AHA in VigiBase. IC compares observed- and expected-values in order to find associations between drugs and adverse drug reactions (ADRs) using disproportionate Bayesian reporting. IC(025) is the lower end of a 95% credibility interval for the IC. Then, we collected cases of drugs significantly associated with AHA from July 2004 to November 2021. RESULTS: 14 drugs with IC(025) > 0 were identified representing a total of 185 cases. D-AHA occurred more frequently in men (59%) than women (41%). The median (min-max) age at onset was 75 years (8-98). The median [Q1-Q3] time to onset of D-AHA from the start of the suspected drug was 30 days [9.5-73.75] and 10% of cases resulted in a fatality. The drugs associated with the highest IC(025) (IC(025) > 2) were Clopidogrel, Alemtuzumab, Omalizumab. This study retrieved for the first time three usually used drugs (3/14) that exhibit a significant pharmacovigilance signal for D-AHA. CONCLUSION: This worldwide pharmaco-epidemiologic study updates the list of the drugs associated with AHA. The clinician should be aware of these possible severe ADR, which might require larger epidemiological and pathophysiologic studies. |
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| 投稿者 | Konstantinov, Konstantin; Dolladille, Charles; Gillet, Benjamin; Alexandre, Joachim; Aouba, Achille; Deshayes, Samuel; Repesse, Yohann |
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| 組織名 | Haematology Laboratory, CHU Caen Normandie, Caen, France.;UNICAEN, EA4650 SEILIRM, CHU de Caen Normandie, Normandie University, Caen,;France.;Department of Pharmacology, CHU de Caen Normandie, Caen, France.;Department of Internal Medicine, UNICAEN, CHU de Caen Normandie, Normandie;University, Caen, France.;Unicaen, Inserm, Physiopathology and Imaging of Neurological Disorders (PhIND),;Normandie University, Caen, France. |
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