Adverse drug reactions of analgesic medicines: analysis of the Romanian pharmacovigilance database
| العنوان: | Adverse drug reactions of analgesic medicines: analysis of the Romanian pharmacovigilance database |
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| المؤلفون: | Felicia Loghin, Irina Cazacu, Françoise Haramburu, Cristina Mogosan, Roxana Dondera, Annie Fourrier-Réglat, Roxana Stroe |
| المساهمون: | Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| المصدر: | Fundamental and Clinical Pharmacology Fundamental and Clinical Pharmacology, Wiley, In press, 32 (3), pp.330-336. ⟨10.1111/fcp.12343⟩ |
| بيانات النشر: | Wiley, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Adolescent, Databases, Factual, Drug-Related Side Effects and Adverse Reactions, Analgesic, Marketing authorization, 030226 pharmacology & pharmacy, Rational use, Pharmacovigilance, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, medicine, Adverse Drug Reaction Reporting Systems, Humans, Pharmacology (medical), 030212 general & internal medicine, Drug reaction, Child, Aged, Retrospective Studies, Aged, 80 and over, PharmacoEpi-Drugs, Pharmacology, Analgesics, Safety studies, Romania, business.industry, Infant, Middle Aged, Prognosis, Metamizole, medicine.disease, 3. Good health, Hospitalization, Child, Preschool, Emergency medicine, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Adverse drug reaction, medicine.drug |
| الوصف: | 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. |
| تدمد: | 0767-3981 1472-8206 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7c089448790b5a15048214dc814902fbTest https://doi.org/10.1111/fcp.12343Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....7c089448790b5a15048214dc814902fb |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 07673981 14728206 |
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