Association Between Topiramate and Zonisamide Use During Pregnancy and Low Birth Weight

Hernández–Dı́az, Sonia; Mittendorf, Robert; Smith, C. R.; Hauser, W. Allen; Yerby, Mark S.; Holmes, Lewis B.

doi:10.1097/aog.0000000000000018

Cited by 66 publications

(41 citation statements)

References 22 publications

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“…The Australian pregnancy register reported a particularly high rate of MCMs for TPM when used as polytherapy, at 14.1 % with a relative risk of 4.32 (95 % CI 1.57-11.05) compared with no AED exposure [13]. Another major concern is a high rate of small for gestational age (SGA) births following in utero exposure to TPM; the NAAPR reported that 17.9 % of TPMexposed infants were SGA with a relative risk of 2.4 (95 % CI 1.8-22) compared with LTG [14]. In 2011, the Food and Drug Administration made a label change, from a Pregnancy Category C to D, based on these reports [15].…”

Section: Tpmmentioning

confidence: 99%

“…Findings from the 2009 AAN/AES practice parameter Update [1] concluded the following : neonates of WWE taking AEDs probably have an increased risk of being SGA of about twice the expected rate. In addition to TPM, elevated prevalence of SGA births has been reported with zonisamide, VPA, and CBZ [14,19]. A retrospective, cross-sectional study utilizing 2 nationwide population-based data sets reported increased ORs (1.3-1.6) for SGA, low birth weight, and preterm deliveries in women who had seizures during pregnancy compared with women without epilepsy, and the risk of SGA births was still increased when compared with WWE who were seizure-free during pregnancy (OR 1.34; 95 % CI 1.01-1.84).…”

Section: Neonatal and Obstetric Complicationsmentioning

confidence: 99%

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Use of Antiepileptic Drugs During Pregnancy: Evolving Concepts

Pennell

2016

Neurotherapeutics

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Although prenatal exposure to antiepileptic drugs (AEDs) is known to impart relatively higher risks of major congenital malformations, prospective studies have provided refined data that allow us to differentiate the risks of different types and doses of AEDs. As the number of AED prescriptions has dramatically increased in reproductive-aged women with a variety of neuropsychiatric indications, the evolving concepts learned from studies in women with epilepsy can be applied to a much larger group of pregnant women to improve child outcomes while maintaining maternal disease control. In addition to careful selection of the type of medication, the amount of fetal exposure at conception and in the first trimester probably matters across all AEDs. Some AED polytherapy regimens are not associated with a higher risk of malformations, although other outcomes have not yet been formally studied. The individual woman's drug target concentration should be established preconception and maintained during pregnancy, to prevent seizure worsening. Substantial pharmacokinetic changes occur with many of the medications during pregnancy and postpartum, and interindividual variability supports the use of therapeutic drug monitoring for most AEDs. During pregnancy, vigilance and close monitoring should also include intrauterine fetal growth, obstetric complications, and neonatal complications. Breastfeeding can provide additional neurodevelopmental benefit and should be an option for women on AEDs. Knowledge of these key principles enhances our ability to make treatment recommendations with resultant improved maternal and child outcomes. Additional prospective studies are needed to further define the risk-benefit ratio across a variety of medications, dosing strategies, and neuropsychiatric disorders.

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Section: Tpmmentioning

confidence: 99%

Section: Neonatal and Obstetric Complicationsmentioning

confidence: 99%

Use of Antiepileptic Drugs During Pregnancy: Evolving Concepts

Pennell

2016

Neurotherapeutics

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“…61 In 2014, the registry also reported an increase in the incidence of low birth weight among infants exposed to TPM in utero (17.9%) compared with controls (5.0%). 62 When compared with lamotrigine-exposed babies, TPM-exposed babies had a 221 g decreased birth weight with a 1 cm decreased mean length. 62 This effect appeared to persist despite adjusting for factors such as age, parity, smoking, education, and folic acid intake.…”

Section: Use In Pregnancymentioning

confidence: 99%

“…62 When compared with lamotrigine-exposed babies, TPM-exposed babies had a 221 g decreased birth weight with a 1 cm decreased mean length. 62 This effect appeared to persist despite adjusting for factors such as age, parity, smoking, education, and folic acid intake. The serum concentrations of TPM appear to decline gradually during pregnancy.…”

Section: Use In Pregnancymentioning

confidence: 99%

Topiramate Extended-Release Options: A Focus on Efficacy and Safety in Epilepsy and Comorbidities

Wang

Wagner

Kaufman

et al. 2017

Clinical Medicine Insights: Therapeutics

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Topiramate (TPM) is effective for multiple seizure types and epilepsy syndromes in children and adults. Topiramate has adverse effects (including cognitive, depression, renal stones), but many of these are low incidence when started at a low dose and slowly titrated to 100 to 200 mg/day. Also, TPM has proven benefit for migraine, obesity, eating disorders, and alcohol use disorders, which can be comorbid in patients with epilepsy and may also be effective in subpopulations within specific psychiatric diagnoses. Recently approved extended-release formulations of TPM (Trokendi and Qudexy in the United States) have reliable data supporting their safety and efficacy for patients with epilepsy. They have potential for more rapid titration within 1 month to 200 mg/day and have better patient retention than TPM immediate-release, but there are no robust double-blind randomized controlled trials comparing the different formulations. We expect the once per day extendedrelease formulations to improve medication adherence compared with the twice per day formulations. This has significant potential to improve outcomes in epilepsy and the other TPM-responsive disorders.

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“…1,18,25 Topiramate has been associated with increased risk of cleft abnormalities, as well as low birth weights and small for gestational age infants. 1,25,27 Emerging data on newer AEDs as monotherapy have demonstrated the relative safety of levetiracetam, 19,28 lamotrigine, 19 oxcarbazepine, and zonisamide 29 in WWE who are pregnant; however, data are more limited for the latter two. Levetiracetam and lamotrigine in particular have not been associated with increased risk of MCM compared to controls and are generally considered safe to use in pregnancy.…”

mentioning

confidence: 99%

Practice Current: How do you treat epilepsy in pregnancy?

George

2017

Neur Clin Pract

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E pilepsy affects millions worldwide and women of childbearing age constitute between 25% and 40% of all patients with epilepsy.1,2 Estimates based on the population in the United States in the 1990s approximate that 25,000 children are born to women with epilepsy (WWE) annually.3,4 For WWE who are pregnant or planning to become pregnant, providers should consider the potential risks regarding seizure control, obstetric complications, and teratogenicity of antiepileptic drugs (AEDs) when counseling patients and determining a treatment plan. 5,6 Studying pregnant women poses unique challenges. Randomized control trials are difficult to conduct in this population, and much of the available data is observational by necessity, which precludes many studies from reaching the most rigorous levels of evidence. Several aspects of the care of pregnant WWE are discussed in this commentary, with a special focus on teratogenicity and drug monitoring. Contraception and prepregnancy planningThe first trimester is the most vulnerable period for fetal development; however, a high rate of pregnancies in WWE-estimated at 65%-are unplanned and may not be recognized until after this time.7 One of the possible causes of this high unplanned pregnancy rate is the interaction between hormonal contraception and enzyme-inducing AEDs, leading to decreased efficacy in preventing pregnancy.As part of prepregnancy planning, folic acid supplementation is often recommended. Evidence for the role of folic acid in preventing major congenital malformations (MCMs) is mixed. Ban et al 8 found no difference between MCM rates between WWE on highdose folic acid (5 mg) and those on low or no folic acid (adjusted odds ratio [aOR] 1.75, 95% confidence interval [CI] 1.01-3.03 vs aOR 1.94, 95% CI 1.21-3.13), although a significant confounder was that a large number of participants were not taking this

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Association Between Topiramate and Zonisamide Use During Pregnancy and Low Birth Weight

Abstract: II.

Cited by 66 publications

References 22 publications

Use of Antiepileptic Drugs During Pregnancy: Evolving Concepts

Use of Antiepileptic Drugs During Pregnancy: Evolving Concepts

Topiramate Extended-Release Options: A Focus on Efficacy and Safety in Epilepsy and Comorbidities

Practice Current: How do you treat epilepsy in pregnancy?

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