Objective: To determine the incidence of adverse drug reactions (ADRs) in children in Camagüey Province, Cuba.
Methods: A national pharmacovigilance programme has been established in Cuba and involves suspected ADRs being reported to provinces. All suspected ADRs reported to Camagüey Province during 2008 were analysed and classified in relation to causality and severity.
Results: Over a 12-month period, there were 124 reports of 152 suspected ADRs in children. Most ADRs were mild (98, 79%), but two were fatal and five others were severe. Antibiotics were the group of medicines most likely to be associated with ADRs. The overall report rate of suspected ADRs was 634 per million children per year, which is considerably higher than previously reported rates.
Conclusions: ADRs in children are more frequent than previously reported. A successful pharmacovigilance programme can be established in lower middle income countries.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1136/adc.2009.180786 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Analyses of Adverse Drug Reactions to Fluoroquinolones in Spontaneous Reports Before and After the Referral and in Clinical Routine Cases.
Drugs R D
January 2025
Research Division, Federal Institute of Drugs and Medical Devices (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Germany.
Introduction: In November 2018, the European Medicines Agency (EMA) restricted the use of fluoroquinolones (used by mouth, injections or inhalation) in the context of a referral due to long-lasting and potentially irreversible adverse drug reactions (ADRs). Fluoroquinolones should no longer be used to treat mild or moderate bacterial infections unless other antibacterials cannot be used.
Objectives: The first aim of our study was to analyze whether in the period before compared with after the referral the characteristics of spontaneous ADR reports related to fluoroquinolones differed and whether specific ADRs were more frequently reported for fluoroquinolones compared with cotrimoxazole.
Medication Hazards and Outcome Patterns of Pediatric Drug-Associated Liver Injury in Taiwan: An Analysis of 1998-2017 Spontaneous Adverse Drug Reaction Reports.
Drugs Real World Outcomes
January 2025
School of Pharmacy, College of Medicine, National Taiwan University, Taipei, 100025, Taiwan.
Background And Objectives: Accumulating pediatric efficacy and safety data on drug use is inherently challenging yet essential. This study aimed to analyze the frequency and compute the odds of pediatric drug-associated liver injury across age groups (early childhood, middle childhood, and adolescence) and therapeutic categories using adverse drug reactions (ADRs) reporting data spanning nearly two decades.
Methods: We analyzed the reports of suspected ADRs occurring in children and adolescents in the Taiwan National Adverse Drug Reaction Reporting System during the period from May 1998 until July 2017.
Do Major Pharmacovigilance Databases Support Evidence of Second Trimester NSAID and Third Trimester Paracetamol Fetotoxicity?
Pharmaceuticals (Basel)
November 2024
Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy, Augustenburger Platz 1, 13353 Berlin, Germany.
Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used during pregnancy. Due to their fetotoxicity, NSAIDs are contraindicated during the third trimester. There is ongoing controversy about the extent to which NSAIDs may cause cardiovascular and renal impairment in the fetus earlier in the second trimester.
View Article and Find Full Text PDFReversible cerebral vasoconstriction syndrome in a methylphenidate-treated patient: a case report.
BMC Neurol
December 2024
Pharmacovigilance, Pharmacoepidemiology and Drug Information Centre, Department of Clinical Pharmacology, Rennes University Hospital, Rennes, 35033, France.
Background: Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe headaches, often thunderclap headaches, and a multifocal constriction of the cerebral arteries. Although RCVS can occur spontaneously, some cases occur after exposure to drugs. We describe the first case of RCVS in which methylphenidate, a drug with vasoconstrictive properties, is the only suspected drug.
View Article and Find Full Text PDFSpontaneous adverse drug reactions reported in a thirteen-year pharmacovigilance program in a tertiary university hospital.
Front Pharmacol
December 2024
Service of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
Objectives: We aimed to assess the characteristics of adverse drug reactions (ADRs) collected in a university hospital.
Methods: A retrospective analysis of ADRs spontaneously reported in the Hospital Pharmacovigilance Program database (RutiRAM) over a 13-year period was conducted. The analysis included a description of ADRs [System Organ Class (SOC)] and their seriousness, the drugs involved [level 1 of the Anatomical Therapeutic Chemical (ATC) Classification System], drug-drug interactions, medication errors, drugs 'under additional monitoring', positive rechallenge, and the 'pharmacovigilance interest' of ADRs.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!