Adverse Effects of Nonsteroidal Anti-inflammatory Drugs in Pediatrics: Case Series According to the Doctor Reports in Republic of Crimea through 2010 to 2018

Abstract

Background. Nonsteroidal anti-inflammatory drugs safety profile (NSAIDs) is well-studied in clinical trials. Meanwhile, the monitoring of adverse effects (AEs) of this drug class and analysis of AEs structure in pediatrics is essential. Our aim was to study AEs related to NSAIDs in children. Methods. Retrospective analysis of doctor reports about AEs associated with drugs from N02B and M01A groups (according to Anatomical Therapeutic Chemical Classification System) administration in patients under 18 years old in healthcare facilities or outpatiently (self-medication included) was carried out. Data source — regional database (Republic of Crimea) of spontaneous reports about AEs. Recall period — January 2010–December 2018. Results. 201 AEs cases were registered during research period. Most commonly AEs on NSAIDs were reported in infants — 87 (43.3%) cases, and in children at 1–3 years old — 65 (32.3%). Development of 126 (62.7%) AEs cases were associated with administration of Ibuprofen drugs, and 53 (26,4%) cases — with Paracetamol drugs. Significance level of cause-effect relationship was estimated in compliance with WHO Collaborating Centre method. For most cases AEs have started with such hypersensitivity reactions (193 cases, 96%) as hives, hyperemia, skin itching. Much less often AEs have presented with respiratory and gastrointestinal disorders. AEs were slight and posed no threat to children in 57% of all cases. Conclusion. AEs development on NSAIDs administration was associated with Ibuprofen and Paracetamol drugs in most cases. Immediate hypersensitivity reactions were the main clinical manifestations of AEs on NSAIDs.