Jorge E Machado-Alba, Andrés Gaviria-Mendoza, Manuel E Machado-Duque, Luis F Valladales-Restrepo, Albert Figueras
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引用次数: 0
Abstract
Purpose: Valproic acid is a known teratogen. The aim was to identify contraceptive use in a group of women using valproic acid.
Methods: Descriptive study. A total of 22 855 women of childbearing age (15-49 years) with at least 1 month of valproic acid use from January 2022 to December 2023 were selected from a Colombian drug-dispensing database. Data on the dispensing of hormonal contraceptives were searched during the study period. The time and rate of coverage (% of the period during which women took contraceptives while using valproic acid/total period of valproic acid consumption) with contraceptives were calculated.
Results: Among the women included, 71.4% (n = 16 308) used 250-mg valproic acid tablets. The mean age was 32.7 (standard deviation [SD]: 9.9) years, and the most common related diagnosis was migraine and headache (n = 5163, 22.6%). Only 8.0% (n = 1832) of the women had at least 1 day of coverage with some contraceptive while using valproate. For the patients with at least 1 day of coverage, the average duration of coverage was 72.5 (SD: 84.7) days (median: 30 days; IQR: 30-86 days). This represents an overall coverage rate of 5.3% (SD: 20.4%) (median: 0.0) and a coverage rate of 65.7% (SD: 35.1%) (median: 75.8%, IQR: 33.3-100%) for those with at least 1 day of coverage.
Conclusions: A significant proportion of women of childbearing age are likely at risk of becoming pregnant while taking valproic acid.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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