ObjectiveTo perform a systematic review of studies describing paediatric adverse drug reactions (ADRs) conducted from national pharmacovigilance databases. MethodsA systematic literature search of studies describing results for paediatric ADRs from national pharmacovigilance databases was performed. PubMed database, Embase and MEDLINE were searched up to March 2015. The descriptive studies included were analysed for country of origin, reporters, and ADR reporting rate, drugs, ADRs and number of fatalities. Results20 studies were identified. Doctors were the largest group of reporters in all the studies, and with more consumer reports seen in USA. The studies ranged from 3 -37 years. The highest ADR reporting rate was 1458 reports per year per million children in Cuba. Antibiotics and vaccines were the most frequently reported drugs, in almost all the studies. The most frequent ADRs were skin and nervous system disorders. The highest proportion of fatalities and serious reports was from North America.Drugs used for treating attention deficit hyperactivity disorders (ADHD) and isotretinoin were the most frequently reported drugs for ADRs in North America. ConclusionsThere were geographical differences in drugs responsible for ADRs and their seriousness, especially in North America. Very few studies were conducted in Asia and Latin America, none were found from Africa.2
Anti-infective agents (antibiotics, anti-malarials and anti-retrovirals) were associated with a majority of the ADRs. Stevens-Johnson syndrome was the most frequent severe ADR. Some of the fatalities were associated with sub-standard and herbal medications.
Aim To describe reported adverse drug reactions (ADRs) for children in the Nigerian pharmacovigilance database. Nigeria has a population of 31 million children. Method The analysis of reports for children aged 0 – 17 years submitted to the Nigerian pharmacovigilance centre from September 2005 to November 2012 was conducted. The data was analysed for number of reports, type of reporters, age and sex of patients. ADRs were classified according to system organ class and preferred terms, severity and outcomes. Results A total of 297 reports were received during the period. For the first 4 years, <10 reports were submitted annually. From 2008, the number of reports has steadily increased to 182 in 2012. The reporting rate by 2012 was 5.9 reports per million children per year. Fifty two percent of the reports were for boys, and children aged 2 – 11 years had more reports (57%) than the other age groups. Pharmacists (49%) submitted more reports than physicians (22%) and other health professionals (23%). Antibiotics (23%), antimalarials (18%) and antivirals (12%) were the most commonly reported drugs. The most frequently reported ADRs were rash (16%), fever (10%), and pruritus (7%). 21 children died (8 from acute renal failure). Seven of the cases of acute renal failure were associated with substandard medicines used for teething problems. Diethylene glycol was identified as a contaminant in 4 of these cases and a further 3 were associated with calcium phosphate/coffee arabica/matricaria recutita/atropa belladonna, an herbal remedy. Fifteen children also experienced a variety of serious ADRs. Metamizole (dipyrone) was associated with 2 deaths and 2 serious ADRs. It was subsequently banned in 2005 in Nigeria. Four children experienced serious ADRs to the antimalarial, dapsone/chlorproguanil. Conclusion The ADR reporting rate for children in Nigeria remains low compared to other countries; however, it has improved dramatically during the last three years. Some of the fatalities were associated with substandard medications. Concerted effort to check and limit these medications in the Nigerian market is recommended.
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