Exposure to pseudoephedrine during pregnancy and major congenital malformations: Findings from a large population-based cohort of pregnancies.

IF 3.1 3区医学 Q2 PHARMACOLOGY & PHARMACY

British journal of clinical pharmacology Pub Date : 2025-02-16 DOI:10.1002/bcp.70001

Saar Dor, Tal Michael, Yael Levi, Gali Pariente, Eitan Lunenfeld, Amalia Levy, Shira Birenstock-Cohen, Sharon Daniel

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引用次数: 0

Abstract

Aims: The aim of this study was to assess the risk of major congenital malformations following first-trimester pseudoephedrine (PSE) exposure.

Methods: A population-based observational cohort study was conducted on pregnancies of women aged 15-49 years, insured by Clalit Health Services in southern Israel, who gave birth or had elective pregnancy terminations due to suspected fetal malformation at Soroka Medical Center (1999-2017). The study focused on Clarinase, a drug that contains a high dose of PSE (120 mg) and 5 mg of loratadine. Multivariable negative binomial regression models were used to evaluate the risk for major congenital malformations, adjusting for potential confounders.

Results: Of 251 543 pregnancies, 313 (0.12%) were exposed to high-dose PSE in the first trimester. PSE exposure was not associated with major congenital malformations overall (adjusted relative risk [aRR] = 0.90, 95% confidence interval [CI] 0.558-1.45; P = 0.66) or by organ system (cardiovascular: aRR = 0.938, 95% CI 0.499-1.762; central nervous system: aRR = 0.618, 95% CI 0.086-4.451; musculoskeletal: aRR = 1.800, 95% CI 0.801-4.042; gastrointestinal: aRR = 1.013, 95% CI 0.142-7.241; genitourinary: aRR = 0.704, 95% CI 0.225-2.204).

Conclusions: First-trimester PSE exposure was not an independent risk factor for major congenital malformations, either overall or by organ system.

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来源期刊

British journal of clinical pharmacology 医学-药学

CiteScore

6.30

自引率

8.80%

发文量

419

审稿时长

1 months

期刊介绍： Published on behalf of the British Pharmacological Society, the British Journal of Clinical Pharmacology features papers and reports on all aspects of drug action in humans: review articles, mini review articles, original papers, commentaries, editorials and letters. The Journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry. It also publishes research on new methods, new drugs and new approaches to treatment. The Journal is recognised as one of the leading publications in its field. It is online only, publishes open access research through its OnlineOpen programme and is published monthly.