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2015, Number 2

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Rev Cubana Farm 2015; 49 (2)

Non-described adverse reactions in pregnant women in Cuba

Furones MJA, Druyet CD, López AÁF, Cruz BMA, Jiménez LG

Language: Spanish
References: 31
Page: 291-303
PDF size: 128.84 Kb.


ABSTRACT

Introduction: The safety profile of drugs in pregnant women is incomplete because they are excluded from the clinical assays. The purpose of pharmacosurveillance is to detect new adverse drug reactions.
Objective: To characterize the non-described adverse reactions in pregnant women in Cuba.
Method: A descriptive and cross-sectional study was conducted and the universe of study was adverse drug reactions in pregnant women reported to the database of the Cuban pharmacosurveillance system. The sample was made up of 126 non described reactions reported from 2003 to 2012. The variables were demographic data, adverse reaction, severity, system of organs, medication, pharmacological group, level of care and notification. Non described adverse reaction was considered as that one not included in the National Formulary of Drugs. The statistical analysis was descriptive.
Results: Non described adverse reactions predominated in pregnant women aged 20 to 30 years (57%), with imprecise gestational age (77%). The most reported year (26%) was 2003. The most common undesirable reactions were headache, tachycardia and nauseas (7.9%), the mild reactions (52.3%) affected the central nervous system (21.4%) caused by antimicrobials (23%), Prenatal® (14.2 %) and risk B drugs (33%) in pregnancy reported more by physicians (67%) of the secondary health care level (56%).
Conclusions: Adverse drug reactions which are not described in pregnant women represented a small portion of the notified ones in the studied decade, with similar characteristics to those of described adverse reactions in terms of severity, category of drug risk in pregnancy and notifying professional.


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