Nine signals were detected from EU Spontaneous Reporting Systems • Amlodipine, rifampicin – a signal of drug interaction between amlodipine and rifampicin leading to reduced antihypertensive effect of amlodipine.
• Cefalexin: a signal of acute generalised exanthematous pustulosis (AGEP)
• Dexmedetomidine – DEXDOR: a signal of polyuria
• Dulaglutide – TRULICITY: a signal of gastrointestinal stenosis and obstruction
• Hydroxycarbamide – SIKLOS: a signal of cutaneous lupus erythematosus
• Ipilimumab – YERVOY: a signal of histiocytosis haematophagic
• Filgrastim – ACCOFIL, FILGRASTIM HEXAL, GRASTOFIL, NIVESTIM, RATIOGRASTIM, TEVAGRASTIM, ZARZIO; lenograstim; lipegfilgrastim – LONQUEX; pegfilgrastim – NEULASTA, RISTEMPA: a signal of aortitis
• Pemetrexed – ALIMTA: a signal of nephrogenic diabetes insipidus.
• Rivaroxaban – XARELTO; Azithromycin; clarithromycin; dirithromycin; erythromycin; flurithromycin; josamycin; midecamycin; miocamycin; oleandomycin; rokitamycin; roxithromycin; solithromycin; spiramycin; telithromycin – KETEK; troleandomycin: a signal of increased risk of bleeding following drug interaction between rivaroxaban and macrolide antiobiotics.
Three new signals were detected from other sources
• Azithromycin: a signal of increased rate of relapses of haematological malignancies and mortality in hematopoietic stem cell transplantation (HSCT) patients with azithromycin.
• Doxycycline: a signal of Jarisch-Herxheimer reaction
• Megestrol; Vitamin K antagonists: acenocoumarol; fluindione; phenindione; phenprocoumon; warfarin: a signal of drug interactions leading to elevated INR/haemorrhage with megestrol and vitamin K agonists
Five signals were identified for follow up and prioritisation
• Azithromycin; tobramycin: a signal of possible interaction between tobramycin and azithromycin leading to lower effectiveness of tobramycin.
• Meningococcal group B vaccine (rDNA, component, adsorbed)
– BEXSERO: a signal of arthritis and synovitis
• Mesalazine: a signal of risk of photosensitivity reactions
• Methotrexate – JYLAMVO, NORDIMET: a signal of pulmonary alveolar haemorrhage
• Pramipexole – MIRAPEXIN, SIFROL, OPRYMEA, PRAMIPEXOLE TEVA, PRAMIPEXOLE ACCORD: a signal of dystonia