Carla Carnovale1, Emanuel Raschi2, Luca Leonardi2, Ugo Moretti3, Fabrizio De Ponti2, Marta Gentili1, Marco Pozzi4, Emilio Clementi4,5, Elisabetta Poluzzi2, Sonia Radice1. 1. a Unit of Clinical Pharmacology Department of Biomedical and Clinical Sciences L. Sacco , 'Luigi Sacco' University Hospital, Università di Milano , Milan , Italy. 2. b Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater Studiorum , University of Bologna , Bologna , Italy. 3. c Department of Diagnostics and Public Health, Section of Pharmacology , University of Verona , Verona , Italy. 4. d Scientific Institute , IRCCS E. Medea , Bosisio Parini , Italy. 5. e Clinical Pharmacology Unit, Department Biomedical and Clinical Sciences, CNR Institute of Neuroscience , L. Sacco University Hospital, Università di Milano , Milan , Italy.
Abstract
BACKGROUND: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. METHODS: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. RESULTS: 116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). CONCLUSION: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful.
BACKGROUND: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. METHODS: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. RESULTS: 116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). CONCLUSION: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful.
Entities:
Keywords:
Adverse event following immunization; antiepileptic toxicity; haemorrages; influenza vaccination; rhabdomyolysis; spontaneous reporting system database; vaccine-drug interactions