Evaluation of developmental toxicity of guaifenesin using pregnant female rats

Shabbir, Arham; Shamsi, Sadia; Shahzad, Muhammad; Butt, Hajra Ikram; Aamir, Khurram; Iqbal, Javed

doi:10.4103/0253-7613.182891

Cited by 3 publications

(3 citation statements)

References 11 publications

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“…Andaloro et al 3 observed that avian embryos exposed to N-methyl-D-aspartate receptor antagonists, including DM, exhibited neural crest defects and NTDs; however, the relevance of these avian experiments to human prenatal exposure generated considerable debate. 20–23 In a study of pregnant female rats, those administered GG had fetuses with decreased fetal weight and decreased skull, forelimb, hindlimb and tail lengths 5 ; however, we did not observe an association between GG and limb deficiencies.…”

Section: Discussioncontrasting

confidence: 72%

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Maternal use of cough medications during early pregnancy and selected birth defects: a US multisite, case–control study

et al. 2021

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ObjectiveTo examine associations between maternal use of cough medications containing dextromethorphan (DM) without guaifenesin (glyceryl guaiacolate (GG)) (‘DM alone’), GG without DM (‘GG alone’) or DM +GG and major birth defects in offspring.DesignPopulation-based case–control study.SettingThe multisite, US National Birth Defects Prevention Study.ParticipantsMothers of 1644 children with neural tube defects (NTDs), 15 110 with non-NTDs, and 10 671 control children without a birth defect diagnosis.Main outcome measuresORs and 95% CIs.ResultsFor NTD analysis, 1.7% of mothers of case children and 1.2% of mothers of control children reported using DM alone, 1.1% and 0.6% GG alone, and 0.4% and 0.2% DM +GG. Respective percentages for non-NTD analysis were 2.2% and 1.9% for DM alone, 1.7% and 1.6% for GG alone, and 0.5% and 0.4% for DM +GG. For all NTDs and subtypes, adjusted OR estimates for DM alone were near the null with 95% CIs that included 1.0. Estimates (95% CI) were 1.8 (1.0 to 3.3) for GG alone and 1.8 (0.6 to 4.8) for DM +GG with all NTDs and 2.2 (1.1 to 4.3) for GG alone with spina bifida. Of the 45 adjusted OR estimates for non-NTDs, 39 ranged from 0.5 to 1.6 with 95% CIs that included 1.0. Near twofold or higher estimates (95% CI) were observed for the remainder and included 1.9 (1.0 to 3.7) for hydrocephalus, 2.9 (1.3 to 6.5) for atrioventricular septal defect and 1.8 (1.1 to 3.0) for transverse limb deficiency with DM alone; 2.1 (1.1 to 4.0) for small intestinal atresia/stenosis and 2.1 (0.9 to 4.5) for omphalocele with GG alone; and 3.2 (1.5 to 6.9) for gastroschisis with DM +GG.ConclusionsMaternal use of medications containing DM alone, GG alone or DM +GG showed positive associations with a small number of birth defects. These observations, which should be interpreted with caution due to small proportions of exposed mothers, may represent true signals or chance findings and warrant evaluation in future studies.

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Section: Discussioncontrasting

confidence: 72%

“…The only animal study, to our knowledge, involving GG reported decreased fetal weight and impaired skeletal development in fetuses of exposed female rats. 5 …”

Section: Introductionmentioning

confidence: 99%

Maternal use of cough medications during early pregnancy and selected birth defects: a US multisite, case–control study

et al. 2021

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“…Pregnancy category C status for GGE was determined by the FDA based on the absence of definitive studies assessing potential risks to the fetus [ 3 , 51 ]. Results of a recently published study in female, pregnant rats, after testing very high doses of guaifenesin, suggest that the risk of fetal abnormalities cannot be ruled out [ 52 ]. The medical literature and safety databases do not show meaningful signals suggesting a significant risk of fetal development issues after pregnant women used guaifenesin.…”

Section: Clinical Safetymentioning

confidence: 99%

Role of guaifenesin in the management of chronic bronchitis and upper respiratory tract infections

Albrecht

Dicpinigaitis

Guenin

2017

Multidiscip Respir Med

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Guaifenesin, a mucoactive drug, acts by loosening mucus in the airways and making coughs more productive. It is used for relief of wet cough and chest congestion due to the common cold, and remains the only legally marketed expectorant in the US (per OTC Monograph). An ingredient in numerous over-the-counter (OTC) cough/cold medications, guaifenesin has a secondary indication for use in stable chronic bronchitis (professional indication). Clinical pharmacology and patient studies support the clinical utility of guaifenesin in respiratory conditions where mucus hypersecretion is prevalent: acute upper respiratory tract infections (URTIs), stable chronic bronchitis, and possibly rhinosinusitis. Guaifenesin has a well-established and favorable safety and tolerability profile in adult and pediatric populations. Its dosing range (200–400 mg 4-hourly, up to 6× daily) allows flexible dose titration to allow an increase of plasma concentrations. Multiple daily doses are needed to maintain 24-h therapeutic effect with immediate-release formulations. Extended-release guaifenesin tablet formulations are available, providing convenience with 12-hourly dosing and portability compared to liquids. Guaifenesin is considered as a safe and effective expectorant for the treatment of mucus-related symptoms in acute URTIs and stable chronic bronchitis. Its clinical efficacy has been demonstrated most widely in chronic respiratory conditions, where excess mucus production and cough are more stable symptoms. Progress is being made to establish clinical models and measures that are more appropriate for studying symptomatic relief with guaifenesin in acute respiratory infections. This will help generate the up-to-date and high-quality data needed to optimize guaifenesin’s effectiveness in established uses, and in new respiratory indications associated with mucus hypersecretion.

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Guaifenesin

Wiegand

2024

Encyclopedia of Toxicology

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Evaluation of developmental toxicity of guaifenesin using pregnant female rats

Cited by 3 publications

References 11 publications

Maternal use of cough medications during early pregnancy and selected birth defects: a US multisite, case–control study

Maternal use of cough medications during early pregnancy and selected birth defects: a US multisite, case–control study

Role of guaifenesin in the management of chronic bronchitis and upper respiratory tract infections

Guaifenesin

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