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2021, Number 4

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Rev Cubana Plant Med 2021; 26 (4)

Characterization of the profile of adverse reactions associated with the use of phytopharmaceuticals in Cuba

Ruiz SAK, García MAJ, Alfonso OI, Carrazana LA, García OM, Morales PM

Language: Spanish
References: 22
Page:
PDF size: 259.58 Kb.


ABSTRACT

Introduction: The use of phytopharmaceuticals has had a marked and upward boom worldwide. The increase in their use is mainly due to the perception that natural products can only be beneficial and lack health risks.
Objective: To characterize the adverse reactions associated with the use of phytopharmaceuticals in Cuba.
Methods: A descriptive, cross-sectional and pharmacovigilance case series study was conducted by spontaneous notification of all reports of suspected adverse reactions to phytopharmaceuticals received at the National Pharmacovigilance Coordinating Unit in the period 2003-2017. The variables studied were sex, age, phytopharmaceuticals and adverse reactions (affected organ system, intensity, imputability and avoidability according to the Standards and Procedures of the Cuban Pharmacovigilance System).
Results: 20.5 % of the cases were avoidable and 11.7 % were in adults. The ratio of women was 2:1 to men. The risk of suffering an avoidable adverse reaction by phytopharmaceutical was 0.04 x per 1000 inhabitants. In the female sex it was higher with a rate of 0.05 x per 1000 inhabitants Most cases were mild (54.6%). 68.5% were considered probable and 15.6% possible. The digestive system was the most affected (52%), regardless of whether they were avoidable or not, followed by the skin with 18.9%. 9.1% and 5.2% of the reactions developed in the cardiovascular and nervous systems, respectively. Garlic was the phytopharmaceutical responsible for most cases, followed by holy cane.
Conclusions: The research carried out allows to describe the safety profile of preventable phytopharmaceuticals in Cuba characterized by mild reactions in adult women. They were probably produced mostly by garlic and holy cane. The most affected organ system was the digestive and skin in second place.


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