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ISSN 0864-3466 (Print)

2015, Number 2

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Revista Cubana de Salud Pública 2015; 41 (2)

Signals of new adverse drug reactions in children

Furones MJA, Barbón PN, Cruz BMA, López AÁF, Jiménez LG, Broche VL

Language: Spanish
References: 24
Page: 217-226
PDF size: 104.01 Kb.


ABSTRACT

Introduction: drug safety in children is not well established, so it is indispensable then to detect new adverse drug reactions called signals.
Objective: to detect signals in adverse drug reactions which have not been described in children but have been reported to the drug surveillance system in Cuba.
Methods: an analytical research was conducted in a universe of 2 237 adverse reactions that have not been described in patients aged 18 or less, but have been recorded in the national drug surveillance database from 2003 to 2012. The variables were warning, alert, suspicion of signal and signal. If the drug/adverse reaction pair was not reported at least three times and the adverse reaction was not described in the international reference sources, then odds ratios of reports were calculated. The pairs having odds rations ≥ 2; 95 % confidence interval excluding 1 and statistically significant Chi square statistic (p ≤ 0,05) were qualitatively evaluated by the experts to detect signals.
Results: one hundred and twenty eight drug/adverse reaction pairs were detected as signal warning, 58 alerts, 15 suspicions of signal and 13 signals. The signals with strongest association were lidocaine plus epinephrine-oral bleeding; ketotifenepistaxis and atropine-injection site pain.
Conclusions: signals of new adverse drug reactions are identified in children under treatment with widely used drugs in the Cuban health system as well as described adverse drug reactions that are omitted in the National Formulary of Pharmaceuticals.


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