Abstract
Children are more exposed to inappropriate medicine use and its consequent harms. Spontaneous reporting of suspected Serious Adverse Drug Reactions (SADR) increases knowledge and prevention of pharmacotherapy risk. Disproportionality measures are useful to quantify unexpected safety issues associated with a given drug-event pair (signals of disproportionality). This cross-sectional study aimed to assess SADR reporting and safety signals for Brazilian children from 0-12 years old, notified between January 2008 and December 2013 from the Brazilian Surveillance Agency (Notivisa). Information from serious reports (gender and age of the patient, event description, suspected drug) was included. Disproportionality analysis based on Reporting Odds Ratios with a confidence interval of 95% was conducted to identify possible signals of disproportionate reporting (SDR). Almost 30% of 1,977 suspected SADR was related to babies (0-1-year-old). 69% of reports happened with intravenous dosage forms, and 35% of suspected SADR involved off label use according to age. Laronidase, miglustat, imipenem/cilastatin, and clofarabine were involved in six or more suspected deaths among 75 deaths reported. There were 107 SDRs, of which 16 events (15%) were not described in the product labels. There was a relatively higher number of SADRs in Brazilian children compared with studies from other countries. SDRs found, (especially drug-event pairs ‘imipenen/cilastatin–pneumonia’ and ‘laronidase–respiratory insufficiency’) should be investigated more. The reports of SADR with IV dosage forms and OL drug use suggest the need for drug research and the use of better dosage forms for children in Brazil.
Highlights
Ensuring safety, efficacy, and quality of medicines for the pediatric population is a challenge because data on many medicines are scarce due to the lack of clinical trials involving children (Joseph et al, 2015)
Serious Adverse Drug Reactions (SADR) were more common in boys (54%) than in girls
28% of suspected SADRs were associated with death, were life-threatening, and caused prolonged hospitalization (Table 1)
Summary
Efficacy, and quality of medicines for the pediatric population is a challenge because data on many medicines are scarce due to the lack of clinical trials involving children (Joseph et al, 2015). Reports of ADRs screening from surveillance systems may offer information about a different drug‐event combination (or pairs) by the mining of a large volume of data (Harpaz et al, 2012). Such safety signals—a potentially causal association or a new aspect of a known association between an intervention and a set of related events—may be critical for drug regulation and improvements in child health (CIOMS, 2010; Osokogu et al, 2016). In Brazil, the first exclusive investigation about children from the Brazilian database (Notivisa) assessed 3,330 spontaneous reports of suspected ADRs and showed approximately 60% were classified as serious events (Lima et al, 2019). This new study aimed to analyze deaths and other serious ADR reports and to identify safety signals in children
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