Information about new adverse drug reactions (ADRs) is generally transmitted through publication in medical journals and spontaneous reporting to regulatory agencies. Paediatricians have partly been deterred from making confidential reports of suspected ADRs due to the > use of drugs in children. Case reports of ADRs published in biomedical journals remain thus an important source of information on the benefit/risk profile of therapies received by children. To define and evaluate the current attention devoted to paediatric drug surveillance in biomedical literature, we performed a systematic survey of recently published case reports. All the relevant case reports on ADRs in children, published in biomedical journals from January 1995 until August 1997 were found through a manual search of the issues of Reactions. A total of 189 references concerning 255 children was retrieved and considered in the analysis. The information was distributed among 88 different journals, but 54 journals (62%) published only one paper each. The most involved were Journal of Pediatrics (15 references) and Medical and Pediatric Oncology (9), 29 countries resulted as having contributed, with the greatest amount of references coming from the USA (77 papers) and the UK (18). A total of 269 ADRs was reported; the most common were behaviour disorders (15 cases), anaphylaxis (13) and seizures (10). A total of 126 different drugs, concerning 275 prescriptions, was suspected of causing the ADRs; gabapentin and valproic acid (12 cases each) were the drugs most frequently involved. ADRs in children remain in > reality in biomedical literature. A multifactorial approach is mandatory to assure a wide enough network of observational points to adequately reflect the variety of contexts influencing the benefit/risk profile of therapy, as part of an > of the overall management of children their problems.
|Translated title of the contribution||Adverse drug reactions in children: A systematic review of published case reports|
|Number of pages||7|
|Journal||Giornale Italiano di Farmacia Clinica|
|Publication status||Published - 1998|
ASJC Scopus subject areas
- Pharmacology (medical)