Adverse drug reactions of analgesic medicines: analysis of the Romanian pharmacovigilance database

Abstract

The results of national safety studies are essential for decision-making at the regulatory level and have also educational implications for prescribing patterns. The aim of this study was to analyze the adverse drug reactions (ADRs) of analgesic medicines spontaneously reported to Pharmacovigilance and Risk Management Service of the Romanian National Agency for Medicines and Medical Devices between 2011 and 2015. For the 71 reports, patients had a mean age of 39.8 years; 60.6% of patients were female, and 38% male and 1.4% were unknown. Reporters were mainly physicians (74.7%), and 52.1% of ADR reports were transmitted through marketing authorization holders. Of the serious ADRs (32.4%), 34.7% led to hospitalization or prolonged hospitalization. The most frequent ADRs reported were skin and subcutaneous tissue disorders (25.8%) and general disorders and administration site conditions (19.2%). Metamizole, alone or in combination, was the main analgesic suspected in almost 15.5% of the cases and remains one of the most popular analgesics in Romania. Ten cases were assessed as preventable or potentially preventable (14%), of which two cases were serious. Even if the level of reporting is still low, this study conducted on ADRs of analgesics reported to the national pharmacovigilance center represents an essential step toward promoting the rational use of analgesics in Romania.

Adverse drug reactions induced by cotrimoxazole: Still a lot of preventable harm

“…Because recommendations for cotrimoxazole prescription (i.e., indication, contraindication, and special warning) did not change, many ADRs related to this antibiotic are still reported, and recent publication of the revival of this antibiotic due to antimicrobial resistance, our results are still useful [14]. Furthermore, our study shows interest of pharmacovigilance databases to identify situations of antibiotic misuse, paving the the way for implementation of improvement measures [15].…”

One hundred years of dipyrone (metamizole): the recent evidence on its safety

“…As the studies cover several aspects related to the safety implications of dipyrone therapy, a didactic division has been made to group the issues in the discussion: dipyrone in children [22][23][24][25][26][27], dipyrone during pregnancy [28], dipyrone and blood dyscrasias [29][30][31][32][33][34], dipyrone in specific diseases [35][36][37][38][39][40][41][42][43][44], in addition to anaphylactic reactions and general adverse effects of dipyrone [45][46][47][48][49][50][51]. About the quality of the studies, it is worth mentioning the scarcity of clinical trials, with the majority being of observational retrospective or cohort design (n = 27).…”

Fatal Events Associated with Adverse Drug Reactions in the Korean National Pharmacovigilance Database

“…The majority of ADEs are mild to moderate, resulting in no harm to reversible harm to patients. The proportion of serious ADEs including life-threatening events and death is not negligible, reported from < 1% up to 67.0% depending on the study population and medications [23][24][25][26][27]. Despite the significance of serious ADEs, few published pharmacovigilance data are available focusing on drug-induced fatal cases [3,6,9,10].…”