Topiramate use in pregnancy and the birth prevalence of oral clefts

Mines, Daniel; Tennis, Patricia; Curkendall, Suellen M.; Li, De-Kun; Peterson, Craig A.; Andrews, Elizabeth; Calingaert, Brian; Chen, Hong; Deshpande, Gaurav; Esposito, Daina B.; Everage, Nicholas J.; Holick, Crystal N.; Meyer, Nicole; Nkhoma, Ella T.; Quinn, Sherry; Rothman, Kenneth J.; Chan, K. Arnold

doi:10.1002/pds.3612

Cited by 76 publications

(60 citation statements)

References 21 publications

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“…Some earlier studies could not identify any deleterious effect of maternal migraine on the development of birth defects, but the analysis of the first part of the HCCSCA has already shown this increased risk . In the case of maternal migraine, it is not clear whether the elevated risk of cleft formation is a consequence of the illness itself or of the drugs used to alleviate its symptoms . Our present findings showed an increased risk of CPO among mothers suffering from cholelithiasis, urolithiasis or neuro‐musculoskeletal pain syndromes as well.…”

Section: Discussioncontrasting

confidence: 66%

Maternal‐related factors in the origin of isolated cleft palate—A population‐based case‐control study

Ács

Bányai

Nemes

et al. 2020

Orthod Craniofacial Res

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Objects Isolated cleft palate (CPO) is the rarest form of oral clefting affecting 1‐25 per 10 000 newborns worldwide. There is increasing evidence for the different pathogenetic backgrounds of CPO and cleft lip with or without cleft palate. The role of environmental factors in the origin of non‐syndromic and syndromic CPO is unclear in most patients. The aim of this study was to estimate possible maternal risk factors in the origin of CPO. Setting and Sample Population The Hungarian Case‐Control Surveillance of Congenital Abnormalities contains data of 32 345 birth defect cases and 57 231 control newborns. The study samples included 751 cases with isolated CPO, 1196 matched controls and 57 231 population controls. Material and Methods Maternal diseases during pregnancy in cases and population controls were compared, and adjusted ORs with 95% CI were calculated in a multivariable unconditional logistic regression model. Results Beyond the well‐known robust female excess (58.9%)—maternal smoking (OR with 95% CI: 2.34, 1.94‐2.81) medically recorded maternal anaemia, threatened abortion and excessive vomiting in pregnancy were associated with a higher risk for CPO in the offspring. An elevated risk was found in Graves’ disease (OR: 4.30, 1.74‐10.62), epilepsy (OR: 4.64, 2.44‐8.82), migraine (OR: 2.82, 1.18‐6.76) and essential hypertension (OR: 2.33, 1.32‐4.10). Among acute diseases common cold (OR: 4.94, 3.48‐7.03), acute respiratory infections (OR: 4.20, 1.49‐11.82), influenza (OR: 2.95, 1.75‐4.95), pulpitis (OR: 7.85, 2.80‐22.03), cholecystitis (OR: 3.15, 1.16‐8.60), acute urinary tract infections (OR: 4.08, 2.22‐7.49) and pelvic inflammatory diseases (OR: 3.93, 1.62‐9.53) during pregnancy also were associated with an increased risk for developing CPO. Conclusion The findings of this study suggest that maternal diseases and lifestyle factors during the first trimester play a significant role in the development of isolated cleft palate.

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Section: Discussioncontrasting

confidence: 66%

Maternal‐related factors in the origin of isolated cleft palate—A population‐based case‐control study

Ács

Bányai

Nemes

et al. 2020

Orthod Craniofacial Res

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“…The increased risk of oral clefts with topiramate was subsequently confirmed in other studies. 26,27 However, the magnitude of the signal for lamotrigine was not confirmed with a larger sample size. 13,28 Thus, when PERs are inadequately powered to study associations for specific MCMs, a much larger number of exposed infants must be surveyed to base an estimate of risk with greater certainty.…”

Section: Target Sample Size and Power Considerationsmentioning

confidence: 88%

A systematic review of pregnancy exposure registries: examination of protocol-specified pregnancy outcomes, target sample size, and comparator selection

Gelperin

Hammad

Leishear

et al. 2016

Pharmacoepidemiol Drug Saf

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No registries were designed to have sufficient power to assess specific malformations, despite the plausibility that most teratogens cause specific defects. Only half of the registries included a power analysis. Despite their common use, external comparators, including MACDP, have important limitations. In the absence of randomized controlled trial data in pregnant women, pregnancy registries remain an important tool as part of a comprehensive pregnancy surveillance program; however, pregnancy registries alone may not be sufficient to obtain adequate data regarding risks of specific malformations. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

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“…NAAPR has also observed a 10-fold increase in the rate of oro-facial clefts among infants exposed to topiramate monotherapy compared to unexposed [15]. A multi-database cohort study recently reported a prevalence of non-syndromic oral clefts 5.4 times higher among children exposed to topiramate in utero compared to unexposed children [16].…”

Section: Different Types Of Mcmsmentioning

confidence: 97%

Major congenital malformations in children of women with epilepsy

Tomson

Hai

Battino

2015

Seizure

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It has been long known that the risk of major congenital malformations is increased among children of mothers with epilepsy. This is mainly due to the teratogenic effects of antiepileptic drugs although other factors, such as genetically determined individual susceptibility, are likely to contribute. Recent large scale prospective epilepsy and pregnancy registries have indicated that the rate of major congenital malformations may be at most two-fold higher than expected with exposure in utero to the presently most frequently used antiepileptic drugs such as carbamazepine or lamotrigine. Higher rates are consistently reported with exposure to valproate. The risk of teratogenic effects appears to be dose dependent and the lowest effective dose should thus be established before pregnancy regardless of which antiepileptic drug the woman is taking. Major changes such as switches between drugs should be avoided when pregnancy is established.

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Topiramate use in pregnancy and the birth prevalence of oral clefts

Abstract: Consistent with other recent epidemiologic research, first-trimester TPM exposure was associated with an elevated birth prevalence of OC.

Cited by 76 publications

References 21 publications

Maternal‐related factors in the origin of isolated cleft palate—A population‐based case‐control study

Maternal‐related factors in the origin of isolated cleft palate—A population‐based case‐control study

A systematic review of pregnancy exposure registries: examination of protocol-specified pregnancy outcomes, target sample size, and comparator selection

Major congenital malformations in children of women with epilepsy

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