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CLINICAL SCIENCES doi: 10.3325/cmj.2011.52.604
Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study
Nikica Mirošević Skvrce1, Viola Macolić Šarinić1, Iva Mucalo2, Darko Krnić1, Nada Božina3, Siniša Tomić4 Pharmacovigilance Department, Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
1
Centre for Applied Pharmacy, Faculty of Pharmacy and Biochemistry, University of Zagreb, Zagreb, Croatia
2
Department of Laboratory Diagnostics, University School of Medicine and University Hospital Center, Zagreb, Croatia
3
Aim To analyze potential and actual drug-drug interactions reported to the Spontaneous Reporting Database of the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and determine their incidence.
Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
4
Methods In this retrospective observational study performed from March 2005 to December 2008, we detected potential and actual drug-drug interactions using interaction programs and analyzed them. Results HALMED received 1209 reports involving at least two drugs. There were 468 (38.7%) reports on potential drug-drug interactions, 94 of which (7.8% of total reports) were actual drug-drug interactions. Among actual drugdrug interaction reports, the proportion of serious adverse drug reactions (53 out of 94) and the number of drugs (n = 4) was significantly higher (P
