Five signals were detected from EU Spontaneous Reporting Systems

• Apixaban – ELIQUIS; dabigatran – PRADAXA; edoxaban – LIXIANA; rivaroxaban – XARELTO – a signal of cholesterol embolisms

• Baricitinib – OLUMIANT – a signal of pneumonia

• Exenatide – BYDUREON, BYETTA – a signal of cardiac arrhythmias

• Iloprost – VENTAVIS – a signal of bradycardia

• Teriflunomide – AUBAGIO – a signal of lymphoma One signal was detected from other sources

• Gonadotropin-releasing hormone (GnRH) agonists: Buserelin; goserelin; leuprorelin; triptorelin – a signal of thromboembolic events

Eight signals were identified for follow up and prioritisation

• Acetazolamide – a signal of acute generalised exanthematous pustulosis (AGEP)

• Azithromycin; clarithromycin; erythromycin; roxithromycin – a signal of AGEP

• Cladribine – LITAK – a signal of progressive multifocal leukoe cephalopathy (PML)

• Desloratadine – AERINAZE; AERIUS, AZOMYR, DASSELTA, DESLORATADINE ACTAVIS, DESLORATADINE RATIOPHARM, DESLORATADINE TEVA, NEOCLARITYN; loratadine – a signal of weight increase in children

• Doxycycline – a signal of doxycycline induced Jarisch-Her heimer reaction

• Flucloxacillin – a signal of high anion gap metabolic acidosis (HAGMA)

• Gefitinib – IRESSA – a signal of recall phenomenon

Insulin: insulin aspart – NOVOMIX, NOVORAPID, RYZODEG; insulin bovine; insulin degludec – TRESIBA; liraglutide – XULTOPHY; insulin detemir – LEVEMIR; insulin glargine – ABASAGLAR, LANTUS, LUSDUNA, TOUJEO; insulin glulisine – APIDRA; insulin human (rDNA) – ACTRAPHANE, ACTRAPID, INSULATARD, INSULIN HUMAN WINTHROP; INSUMAN – MIXTARD, PROTAPHANE; insulin human; insulin isophane; insulin lispro – HUMALOG, LIPROLOG; insulin porcine – a Signal of potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia