In utero drug exposure and hearing impairment in 2-year-old children A case-control study using the EFEMERIS database

Foch, Caroline; Araujo, Mélanie; Weckel, Alexandra; Damase‐Michel, Christine; Montastruc, Jean‐Louis; Bénevent, Justine; Durrieu, Geneviève; Lacroix, Isabelle

doi:10.1016/j.ijporl.2018.07.035

Cited by 12 publications

(6 citation statements)

References 14 publications

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“…Valproic acid is a known teratogen [49], and a dose-response relation has been reported for this association [5], with variations across types of major congenital malformations [50]. In-utero exposure to valproic acid has also been reported to be associated with hearing impairment [51] and to have a dose-response relation with adverse developmental, cognitive, and behavioral outcomes [8, 10, 52]. In 2014, the European Medicines Agency (EMA) conducted a review on the pregnancy safety of valproic acid, after which it imposed a number of risk minimization activities in Europe [53].…”

Section: Discussionmentioning

confidence: 99%

Relation of in-utero exposure to antiepileptic drugs to pregnancy duration and size at birth

Margulis¹,

Hernández–Dı́az

McElrath

et al. 2019

PLoS ONE

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Background The associations of individual antiepileptic drugs (AEDs) with pregnancy duration and size at birth, and potential dose relations, are not well characterized. Methods This cohort study used nationwide Swedish register data (1996–2013). Adjusting for smoking, epilepsy and other AED indications, we used linear and quantile regression to explore associations with pregnancy duration, and birth weight, length, and head circumference (the last three operationalized as z-scores). We used logistic regression for preterm delivery, small for gestational age, and microcephaly. Lamotrigine was the reference drug. Results 6,720 infants were exposed to AEDs in utero; AED exposure increased over the study period. Relative to lamotrigine-exposed infants, carbamazepine-exposed infants were born, on average, 1.3 days earlier (mean [95% confidence interval]: -1.3 [-2.3 to -0.3]); were 0.1 standard deviations (SDs) lighter (-0.1 [-0.2 to 0.0]); and had a head circumference that was 0.2 SDs smaller (-0.2 [-0.3 to -0.1]). Pregabalin-exposed infants were born, on average, 1.1 days earlier (-1.1 [-3.0 to 0.8]); were 0.1 SDs lighter (-0.1 [-0.3 to 0.0]); and had the same head circumference as lamotrigine-exposed infants. Levetiracetam-exposed infants were born, on average, 0.5 days earlier (-0.5 [-2.6 to 1.6]); were 0.1 SDs lighter (-0.1 [-0.3 to 0.0]); and had a head circumference 0.1 SDs smaller (-0.1 [-0.3 to 0.1]). Valproic acid–exposed infants had, on average, the same duration of gestation and birth weight z-score as lamotrigine-exposed infants, but had a head circumference 0.2 SDs smaller (-0.2 [-0.2 to -0.1]). Associations between carbamazepine exposure and pregnancy duration and between valproic acid exposure and pregnancy duration and birth weight z-score were more negative at the left than at the right tails of the outcome distributions. Effect-measure modification and dose-response relations were noted for some of the associations. Conclusions Relative to lamotrigine, valproic acid and carbamazepine were associated with smaller head circumference.

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Section: Discussionmentioning

confidence: 99%

Relation of in-utero exposure to antiepileptic drugs to pregnancy duration and size at birth

Margulis¹,

Hernández–Dı́az

McElrath

et al. 2019

PLoS ONE

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“…A similar high proportion of SNHL was also reported by Bastos et al in a review of hearing loss in Tanzanian school children, as well as reports from Pakistan and Nigeria (44–47). This higher rate of SNHL in LMIC compared with high-income countries is believed to be because of that relative high prevalence of infectious causes (e.g., meningitis, rubella, CMV, or untreated otitis media), exposure to ototoxic medications, genetic etiologies (especially in communities with high rates of consanguinity) and exposure to environmental toxins (4,18,48–54).…”

Section: Discussionmentioning

confidence: 99%

“…Unfortunately, our dataset does not include information regarding the specific types of drug or pesticide exposures. Maternal drug exposures and tobacco exposures are suspected to increase the risk of congenital hearing loss (48,55). We did not find an association with tobacco use in this cohort.…”

Section: Discussionmentioning

confidence: 99%

School Hearing Screening With a Portable, Tablet-Based, Noise-Attenuating Audiometric Headset in Rural Nicaragua

et al. 2022

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Objective: To investigate the utility and effectiveness of a noiseattenuating, tablet-based mobile health system combined with asynchronous telehealth evaluations for screening rural Nicaraguan schoolchildren for hearing loss. Study Design: Prospective population-based survey. Setting: Rural Nicaraguan communities. Patients: There were 3,398 school children 7 to 9 years of age. Intervention(s): Diagnostic automated and manual audiometry, detailed asynchronous telehealth evaluations Main Outcome Measure(s): Referral rates, ambient noise levels, and audiometric results as well as hearing loss prevalence, types, and risk factors. Results: Despite high ambient noise levels during screening (46.7 dBA), no effect of noise on referral rates on automated audiometry or confirmatory manual audiometry in those who failed automated testing was seen. The overall audiometric referral rate was 2.6%. Idiopathic sensorineural hearing loss (SNHL) and cerumen impaction were the most common types of hearing loss in this population with an estimated prevalence of hearing loss (all types) of 18.3 per 1,000 children. SNHL was associated with both drug exposure during pregnancy (p = 0.04) and pesticide exposure in the home (p = 0.03). Conclusion: Hearing screening using a tablet-based, noise-attenuating wireless headset audiometer is feasible and effective in rural low-resource environments with moderately elevated ambient noise levels. The referral rate with noise-attenuating headsets was much lower than that previous reports on this population. In addition, manual audiometry resulted in much lower referral rates than automated audiometry. The confirmed hearing loss rate in this study is comparable to reports from other low-income countries that use some form of noise attenuation during screening. Pesticide exposure and drug exposure during pregnancy are potential causes of SNHL in this population.

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“…26 In addition, one case-control study showed that when used during pregnancy this drug was associated with the occurrence of hearing loss in the child. 27 Most medications used before pregnancy were classified by the FDA as risk C in the first months of pregnancy and contraindicated by Anvisa. This situation is explained because most women were not aware of their pregnancy and so used contraindicated medications.…”

Section: Maternal Characteristicsmentioning

confidence: 99%

Use of medications by pregnant women in the Family Health Strategy in the Northeast of Brazil

Campos

Mattos

Gomes

2022

Rev. Bras. Saude Mater. Infant.

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Objectives: To evaluate the medication use, exposure to potential risks, and associated factors before and during pregnancy of pregnant women receiving care at the Family Health Strategy in a municipality in the Northeast of Brazil. Methods: This is a cross-sectional study of pregnant women receiving care in the municipality of Barreiras, in Bahia, Brazil. In data analysis process, prevalence and frequency of medication use were estimated. To investigate the association between variables, the outcome measure was expressed by the prevalence ratio (crude and adjusted) with a 95% confidence interval via Poisson regression. Results: The prevalence of medication use before pregnancy was 35% and during pregnancy, it was 80.7%. Analgesics and antianemics were the prevalent groups of medications before and during pregnancy, respectively. Family income (≤1 minimum wage; PR=1.62; CI95%=1.02-2.55) showed an association with prior use; health problems (PR=2.3; CI95%=1.27-4.22) and complaints in pregnancy (PR=2.39; CI95%=1.28-4.47) had an association with use during pregnancy. Conclusion: The characterization of a high prevalence of use of medicines by pregnant women, combined with a trend of failures in family planning could demonstrate the exposure of the risks of using some harmful substances in periods close to conception and pregnancy.

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In utero drug exposure and hearing impairment in 2-year-old children A case-control study using the EFEMERIS database

Cited by 12 publications

References 14 publications

Relation of in-utero exposure to antiepileptic drugs to pregnancy duration and size at birth

Relation of in-utero exposure to antiepileptic drugs to pregnancy duration and size at birth

School Hearing Screening With a Portable, Tablet-Based, Noise-Attenuating Audiometric Headset in Rural Nicaragua

Use of medications by pregnant women in the Family Health Strategy in the Northeast of Brazil

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