The AED (Antiepileptic Drug) Pregnancy Registry

Holmes, Lewis B.; Wyszynski, Diego F.; Lieberman, Ellice

doi:10.1001/archneur.61.5.673

Cited by 209 publications

(121 citation statements)

References 24 publications

(14 reference statements)

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“…There is not any particular rationale or specific reason that PB has been listed as a scheduled substance other than that it is a barbiturate and therefore has a potential to be a drug of abuse. 3 In China, where large demonstration project and national epilepsy programs have taken place, there have been no major negative impact on cognitive function of people with convulsive seizures treated with PB, but instead cognitive gains have been observed as a result of PB treatment. 4 Treatment guidelines call for controlled substances such as AEDs to be readily available, but this has not been the case in many LMICs.…”

Section: Essential Drug Status Versus Controlled Substance Statusmentioning

confidence: 99%

“…16 The teratogenic risk of PB in pregnancy may be higher than that of some other AEDs. 3 But for the moment, LMICs are often presented with either having a treatment with PB or having no treatment at all. 17 Therefore, any barriers to its use in countries needing it should be reduced.…”

Section: Potential Cons Of Pbmentioning

confidence: 99%

“…The low interest in our study on genetic risk factors could potentially also be explained by the fact that, although it was an anonymous study, there still was the fear that the results would have consequences for other family members. This issue was addressed by Dlugos et al, 3 who looked at the inclusion rate of children in a genetic susceptibility study on the common forms of epilepsy. In their study, they found that patients refused because of the fear of phlebotomy and not because of the fear of genetic testing.…”

Section: Recruitment Of Patients With Both Epilepsy and Intellectual mentioning

confidence: 99%

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Undue regulatory control on phenobarbital—an important yet overlooked reason for the epilepsy treatment gap

et al. 2015

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International audienceEpilepsy is a major chronic noncommunicable neurologic disorder. Although a simple, safe, efficacious, and low-cost treatment has been available for nearly 100 years, the treatment gap remains disturbingly high in many low- and middle-income countries (LMICs).[1] Treatment gap is generally defined as a “difference between the number of people with active epilepsy and the number being appropriately treated.” There are many reasons for this treatment gap; one important reason is an overly restrictive regulation on barbiturates such as phenobarbital (PB). These restrictive regulations deserve a wider and open discussion, even though epileptologists and others are intensely engaged on reducing the epilepsy treatment gap. With this article, we provide our viewpoint with an aim of raising an extremely important issue: undue regulatory restriction on phenobarbital, an essential lifesaving antiepileptic drug (AED)

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Section: Essential Drug Status Versus Controlled Substance Statusmentioning

confidence: 99%

Section: Potential Cons Of Pbmentioning

confidence: 99%

Section: Recruitment Of Patients With Both Epilepsy and Intellectual mentioning

confidence: 99%

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Undue regulatory control on phenobarbital—an important yet overlooked reason for the epilepsy treatment gap

et al. 2015

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“…20 Phenobarbital is associated with a significantly increased risk of fetal abnormalities. 21 Hepatic metabolism is induced by PB, and the clearance of concomitantly administered hepatically metabolized drugs, including hormonal contraceptives, 15 is increased.…”

Section: Phenobarbitalmentioning

confidence: 99%

Currently Available Antiepileptic Drugs

Schachter

2007

Neurotherapeutics

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Summary:Many new antiepileptic drugs (AEDs) have become available over the past 15 years. At the same time, the emphasis on treating patients with epilepsy has grown from stopping seizures to avoiding side effects and maximizing quality of life. This review summarizes currently available AEDs, and presents general treatment principles and guidelines for AED selection. Unfortunately, despite the increased treatment options of today, seizure freedom without side effects remains unattainable for too many patients with epilepsy. Consequently, there remains a significant need for further development of new therapies.

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“…Major malformations affected 4.5% and 8.6% of these infants, respectively. Other authors observed major birth defects in 3.2 -7.8% of pregnancies complicated by AED monotherapy, and 6.0 -9.3% in AED polytherapy [Artama et al, Canger et al, 1999;Cunnington et al, 2005;Kaaja et al, 2003;Kaneko et al, 1999;Mawer et al, 2010;Morrow et al, 2006;Samren et al 1999;Wide et al, 2004;Wyszynski et al, 2004;. The meta analysis of 26 studies compiled by Tomson and Battino revealed a major congenital malformation (MCM) rate of 6.1% in offspring of women with epilepsy who were treated with AEDs, 2.8% among children of women with untreated epilepsy, and 2.2% in the healthy control group .…”

Section: Introductionmentioning

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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The AED (Antiepileptic Drug) Pregnancy Registry

Abstract: A hospital-based pregnancy registry can establish the fetal risk of major malformations for a commonly used drug. Prenatal exposure to phenobarbital is associated with a significantly increased risk of fetal abnormalities.

Cited by 209 publications

References 24 publications

Undue regulatory control on phenobarbital—an important yet overlooked reason for the epilepsy treatment gap

Undue regulatory control on phenobarbital—an important yet overlooked reason for the epilepsy treatment gap

Currently Available Antiepileptic Drugs

Antiepileptic Drugs and Pregnancy Outcomes

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