Relationship between adverse drug reactions to antibacterial agents and the Klebsiella pneumoniae carbapenemase-producing (KPC) Klebsiella pneumoniae outbreak: insight from a pharmacovigilance study

Table 4 Serious ADR reports collected in AIFA and Yellow Card Scheme Databases

Antibiotics	1999–2008^a	2009–2018^c	p value
Colistin
AIFA (mean per year ± SD)	0.3 ± 0.5	5 ± 3.7	0.00291
Yellow Card Scheme (mean per year ± SD)	1.6 ± 3.3	6.5 ± 2.9	0.00264
Gentamicin
AIFA (mean per year ± SD)	2.3 ± 2.4	7.9 ± 5.0	0.015
Yellow Card Scheme (mean per year ± SD)	10.7 ± 4.6	26 ± 14.7	0.00977
Meropenem
AIFA (mean per year ± SD)	2 ± 1.7	19.5 ± 7.3	< 0.0001
Yellow Card Scheme (mean per year ± SD)	7.9 ± 4.5	29.8 ± 8.5	< 0.001
Tigecyclin
AIFA^b(mean per year ± SD)	0.3 ± 0.6	6.3 ± 3.0	< 0.001
Yellow Card Scheme^b(mean per year ± SD)	9.3 ± 4.6	5.7 ± 3.4	0.30
Ceftazidime-Avibactam^c
AIFA (mean per year ± SD)	–	5.7 ± 4.0	–
Yellow Card Scheme (mean per year ± SD)	–	4.7 ± 5.0	–

ISSN: 2050-6511