Levetiracetam use and pregnancy outcome

Berg, K. ten; Samrén, E. Bettina; Oppen, A. Carla van; Engelsman, Martijn; Lindhout, Dick

doi:10.1016/j.reprotox.2004.12.001

Cited by 45 publications

(7 citation statements)

References 13 publications

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“…There were also no minor malformations in the LEV monotherapy group which included 39 monotherapy exposures. Other smaller reports also did not identify any LEV-related malformations (Long 2003; ten Berg et al 2005). Four infants exposed to LEV monotherapy had a low birth rate, but the mean birth weight for infants exposed to LEV was within the normal range (Hunt et al 2006).…”

Section: Levetiracetammentioning

confidence: 77%

Levetiracetam in the treatment of epilepsy

Abou‐Khalil

2008

NDT

198

136

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Epilepsy is a common chronic disorder that requires long-term antiepileptic drug therapy. Approximately one half of patients fail the initial antiepileptic drug and about 35% are refractory to medical therapy, highlighting the continued need for more effective and better tolerated drugs. Levetiracetam is an antiepileptic drug marketed since 2000. Its novel mechanism of action is modulation of synaptic neurotransmitter release through binding to the synaptic vesicle protein SV2A in the brain. Its pharmacokinetic advantages include rapid and almost complete absorption, minimal insignifi cant binding to plasma protein, absence of enzyme induction, absence of interactions with other drugs, and partial metabolism outside the liver. The availability of an intravenous preparation is yet another advantage. It has been demonstrated effective as adjunctive therapy for refractory partial-onset seizures, primary generalized tonic-clonic seizures, and myoclonic seizures of juvenile myoclonic epilepsy. In addition, it was found equivalent to controlled release carbamazepine as fi rst-line therapy for partial-onset seizures, both in effi cacy and tolerability. Its main adverse effects in randomized adjunctive trials in adults have been somnolence, asthenia, infection, and dizziness. In children, the behavioral adverse effects of hostility and nervousness were also noted. Levetiracetam is an important addition to the treatment of epilepsy.

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Section: Levetiracetammentioning

confidence: 77%

Levetiracetam in the treatment of epilepsy

Abou‐Khalil

2008

NDT

198

136

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“…Based on significant evidence [151], the US Public Health Service recommends that all women of childbearing potential consume 0.4 mg/day of folic acid (commonly available in over-the-counter multivitamin supplements) to reduce their risk of having a child with a neural tube defect (NTD) [149]. Furthermore, it is recommended that high-risk women take 4 mg/day [152–154].…”

Section: Treatment Guidelinesmentioning

confidence: 99%

Teratogenic effects of antiepileptic drugs

Hill

Wlodarczyk

Palacios

et al. 2010

Expert Review of Neurotherapeutics

123

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Many antiepileptic drugs (AEDs) have therapeutic applications that extend beyond epilepsy to include neuropathic pain, migraine headaches and psychiatric disorders. The risk of some AEDs has been clearly established, but for newer drugs, small sample sizes and polytherapy exposures preclude a conclusive determination of their teratogenic potential. Most women with epilepsy will require AED therapy throughout their entire pregnancy to control seizures; the vast majority of pregnancies in women with epilepsy have positive outcomes. A conservative estimate suggests that AED monotherapy doubles, and polytherapy triples, the risk for major congenital malformations. Furthermore, while evidence is still accruing, recent investigations suggest that exposure to select AEDs results in altered cognitive function later in development. There is no evidence to suggest that additional folic acid supplementation ameliorates the increased risk of congenital malformations conferred by in utero AED exposure.

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“…During well‐controlled trials in the development of LEV, 23 women became pregnant while taking LEV 1000– 4000 mg/day as either monotherapy or adjunctive therapy (French et al 2001; ten Berg et al 2005). Pregnancy outcomes were: eight healthy children, one child with syndactyly, one child with congenital heart disease, one prematurely delivered child with abnormal heart rhythm, one ectopic pregnancy, seven spontaneous and three voluntary abortions, and two unknown outcomes.…”

Section: Postmarketing Surveillancementioning

confidence: 99%

“…One series of case reports has shown a normal pregnancy outcome and regular birth weights in three patients on LEV monotherapy at a dose of 750–3000 mg LEV daily (Long 2003). Ten Berg and colleagues presented the outcome of 11 well‐documented pregnancies from a consecutive series of LEV‐exposed pregnancies registered in EURAP in The Netherlands (ten Berg et al 2005). LEV was prescribed as monotherapy to two women and as combination therapy to eight women (doses varied from 500 to 3500 mg/day).…”

Section: Postmarketing Surveillancementioning

confidence: 99%

Levetiracetam: Part II, the Clinical Profile of a Novel Anticonvulsant Drug

et al. 2007

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The objective of this article was to review and summarize the available reports on the profile of the novel anticonvulsant drug levetiracetam (LEV) in a clinical setting. Therefore, a careful search was conducted in the MEDLINE database and combined with guidelines from regulatory agencies, proceedings of professional scientific meetings, and information provided by the manufacturers. This article is devoted to the clinical pharmacology and clinical trials of LEV investigating its efficacy and safety as add-on therapy or monotherapy for various seizure types. Finally, results from postmarketing surveillance of LEV are briefly discussed. In general, LEV is shown to be a safe, broad-spectrum anticonvulsant drug with highly beneficial pharmacokinetic properties, a favorable long-term retention rate, and a high responder rate, indicating that LEV is an efficient therapeutic option for the treatment of several types of epilepsy. CLINICAL PHARMACOLOGYLevetiracetam (LEV) is a white to off-white powder with a bitter taste and faint odor that is highly soluble in water (0.104 g/mL). It is structurally unrelated to other anticonvulsant drugs (ACDs), with an empirical formula of C 8 H 14 N 2 O 2 and a molecular weight of 170.21.

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Levetiracetam use and pregnancy outcome

Cited by 45 publications

References 13 publications

Levetiracetam in the treatment of epilepsy

Levetiracetam in the treatment of epilepsy

Teratogenic effects of antiepileptic drugs

Levetiracetam: Part II, the Clinical Profile of a Novel Anticonvulsant Drug

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