In utero antiepileptic drug exposure

Meador, Kimford J.; Baker, Gus A.; Finnell, Richard H.; Kalayjian, Laura A.; Liporace, Joyce; Loring, David W.; Mawer, G. E.; Pennell, Page B.; Smith, Jacqueline; Wolff, Markus

doi:10.1212/01.wnl.0000227919.81208.b2

Cited by 267 publications

(213 citation statements)

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“…2,3 This transition is propagated by the burgeoning lamotrigine reproductive safety data. Briefly, the overall risk of major fetal malformations after first-trimester prenatal exposure to lamotrigine is 2.6% (83 of 3176 exposures, including 0.32% [8 of 2537] for midline cleft formations), [4][5][6][7][8][9][10] rates that are within the range of births not involving drug exposures. A recent report by the North American Pregnancy Registry noted a relatively high rate of midline facial clefts (0.89% of 564 exposures) 8 ; however, the collective rate of orofacial clefts in the other registries was only 0.15% (2 of 1937 exposures).…”

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confidence: 99%

“…A recent report by the North American Pregnancy Registry noted a relatively high rate of midline facial clefts (0.89% of 564 exposures) 8 ; however, the collective rate of orofacial clefts in the other registries was only 0.15% (2 of 1937 exposures). [4][5][6][7]9,10 The United Kingdom Epilepsy and Pregnancy Register reported higher risk of malformations at maternal daily doses exceeding 200 mg, 10 although this was not confirmed in a subsequent analysis of the manufacturer's registry. 7 The transplacental passage of lamotrigine both in placental perfusion and umbilical cord blood at delivery indicates that fetal exposure is equal to maternal plasma concentrations.…”

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confidence: 99%

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Lamotrigine in Breast Milk and Nursing Infants: Determination of Exposure

et al. 2008

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OBJECTIVE-Although lamotrigine use during pregnancy has substantially increased over the past decade secondary to accumulated reproductive safety data, systematic data on lamotrigine during breastfeeding remains sparse. We sought to characterize the determinants of lamotrigine concentrations in breast milk and nursing-infant plasma.PATIENTS AND METHODS-Women who enrolled in a prospective investigation of perinatal medication pharmacokinetics, were treated with lamotrigine, and chose to continue lamotrigine while breastfeeding were included in the analysis. Breast milk samples were collected via breast Address correspondence to D. Jeffrey Newport, MD, Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, 1365 Clifton Rd NE, Suite B6100, Atlanta, GA 30322. jeff.newport@emory.edu. Financial Disclosure: Dr Newport has received research support from Eli Lilly, GlaxoSmithKline, Janssen, Wyeth, the National Alliance for Research on Schizophrenia and Depression, and the National Institutes of Health and speaker's honoraria from AstraZeneca, Eli Lilly, GlaxoSmithKline, and Pfizer; Dr Pennell has received research support from GlaxoSmithKline, the National Institutes of Health, Marinus Pharmaceuticals, and UCB Pharma, has served on advisory boards for GlaxoSmithKline and UCB Pharma, and received speaker's honoraria from GlaxoSmithKline and UCB Pharma; Ms Calamaras has received National Institutes of Health research support; Dr Ritchie has received research support from GlaxoSmithKline and has served on advisory boards for CeNeRx Pharma and Abaxis; Ms Newman has received research support from GlaxoSmithKline, the National Institutes of Health, Marinus Pharmaceuticals, and UCB Pharma; Ms Knight has received research support from Bristol-Myers Squibb, Cyberonics, Eli Lilly, Forest, Janssen, the National Institutes of Health, Novartis, and Wyeth; Dr Viguera has received research support from the National Institutes of Health, the National Alliance for Research on Schizophrenia and Depression, a Harvard Medical School Scholars in Medicine Fellowship Award (Claflin Award), the Stanley Medical Research Institute, Astra-Zeneca, Berlex Laboratories, Eli Lilly, Forest, Pfizer, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sepracor, and Wyeth, has served on advisory boards to GlaxoSmithKline, Novartis, and Wyeth, and received speakers' honoraria from Astra-Zeneca, Eli Lilly, GlaxoSmithKline, Novartis, and Wyeth; Dr Liporace receives research support from the National Institutes of Health and is on the speaker's bureau and advisory board for UCB Pharma and GlaxoSmithKline but does not receive financial compensation for these services; and Dr Stowe has received research support from GlaxoSmithKline, the National Institutes of Health, and Wyeth, served on advisory boards for Wyeth, Bristol-Myers Squibb, and GlaxoSmithKline, and received speakers' honoraria from Eli Lilly, GlaxoSmithKline, Pfizer, and Wyeth. pump from foremilk to hindmilk from a single breast to determine the excretion gradient and...

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Lamotrigine in Breast Milk and Nursing Infants: Determination of Exposure

et al. 2008

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“…The UK Pregnancy Registry had three-times as many MCM cases from VPA exposure as from CBZ (6.2 versus 2.2%) [Morrow et al, 2006], and the International Lamotrigine (LMT) Pregnancy Registry found 12.5% MCMs when mothers received LMT polytherapy with valproate versus 2.7% MCMs from other LMT polytherapy regimens without valproate [Cunnington and Tennis, 2005]. Most recently, the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) Study Group confirmed both an increased risk of adverse fetal outcomes (MCM or death) and the dosedependent effect of VPA in a prospective study (20.3% with VPA as opposed to 10.7% with PHT, 8.2% with CBZ and 1% with LMT) [Meador et al, 2006].…”

Section: Phenobarbital (Solfoton)mentioning

confidence: 99%

Antiepileptic Drugs and Pregnancy Outcomes

Wlodarczyk

Palacios

George³

et al. 2012

Obstetrical &Amp; Gynecological Survey

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The treatment of epilepsy in women of reproductive age remains a clinical challenge. While most women with epilepsy require anticonvulsant drugs for adequate control of their seizures, the teratogenicity associated with some antiepileptic drugs is a risk that needs to be carefully addressed. Antiepileptic medications are also used to treat an ever broadening range of medical conditions such as bipolar disorder, migraine prophylaxis, cancer and neuropathic pain. Despite the fact that the majority of pregnancies of women with epilepsy who are receiving pharmacological treatment are normal, studies have demonstrated that the risk of having a pregnancy complicated by a major congenital malformation is doubled when comparing the risk of untreated pregnancies. Furthermore, when antiepileptic drugs (AEDs) are used in polytherapy regimens, the risk is tripled, especially when valproic acid (VPA) is included. However, it should be noted that the risks are specific for each anticonvulsant drug. Some investigations have suggested that the risk of teratogenicity is increased in a dose-dependent manner. More recent studies have reported that in utero exposure to AEDs can have detrimental effects on the cognitive functions and language skills in later stages of life. In fact, the FDA just issued a safety announcement on the impact of VPA on cognition (Safety Announcement 6-30-2011). The purpose of this document is to review the most commonly used compounds in the treatment of women with epilepsy, and to provide information on the latest experimental and human epidemiological studies of the effects of antiepileptic drugs in the exposed embryos.

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“…NCC give rise to rib cage (Henderson et al, 1999); (1) (Grandjean et al, 1997); (2) (Grandjean and Landrigan, 2006); (3) (Opler et al, 2008); (4) (Ha et al, 2009); (5) (Tian et al, 2009); (6) (Kippler et al, 2012); (7) (Hamadani et al, 2011); (8) (Saha et al, 2012); (9) (Eubig et al, 2010); (10) (Patandin et al, 1999); (11) (Valvi et al, 2012); (12) (Lai et al, 2002); (13) (Chen et al, 1992); (14) (Zarn et al, 2004); (15) (Di Renzo et al, 2007); (16) (Machera, 1995); (17) (Giavini and Menegola, 2010); (18) (Krieger, 2004); (19) (Dean et al, 2002); (20) (Arndt et al, 2005); (21) (Meador et al, 2006); (22) (Rasalam et al, 2005); (23) (Menegola et al, 2005b); (24) (Verbois, 2006); (25) (Valenzuela-Fernandez et al, 2008).…”

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