Prenatal use of newer antiepileptic drugs not associated with increased risk of major birth defects

May 17, 2011

Use of newer-generation antiepileptic drugs, which are also prescribed for bipolar mood disorders and migraine headaches, during the first trimester of pregnancy was not associated with an increased risk of major birth defects in the first year of life among infants in Denmark, according to a study in the May 18 issue of JAMA. Older-generation antiepileptic drugs are associated with an increased risk of birth defects.

"Epilepsy during is a therapeutic challenge. Since the 1990s, the number of licensed antiepileptic drugs has substantially increased, but safety data on first-trimester use of newer-generation antiepileptic drugs and birth defects are limited," according to background information in the article.

Ditte Molgaard-Nielsen, M.Sc., and Anders Hviid, M.Sc., Dr.Med.Sci., of the Statens Serum Institut, Copenhagen, Denmark, conducted a study to analyze the association between the use of lamotrigine, oxcarbazepine, topiramate, gabapentin, and levetiracetam (newer-generation antiepileptic drugs) during the first trimester of pregnancy and the risk of any major birth defects. The study included data on 837,795 live-born infants in Denmark from January 1996 through September 2008. Individual-level information on dispensed antiepileptic drugs to mothers, birth defect diagnoses, and potential confounders (factors that can influence outcomes) were ascertained from nationwide health registries.

Among the included in the study (837,795), 19,960 were diagnosed with a major birth defect (2.4 percent) during the first year of life. Among 1,532 pregnancies exposed to lamotrigine, oxcarbazepine, topiramate, gabapentin, or levetiracetam at any time during the first trimester, 49 infants were diagnosed with a major (3.2 percent) compared with 19,911 infants (2.4 percent) among 836,263 unexposed pregnancies. After adjusting for various factors, the authors found that exposure to lamotrigine, oxcarbazepine, topiramate, gabapentin, or levetiracetam at any time during the first trimester was not associated with an increased risk of major birth defects. Gabapentin and levetiracetam exposure during the first trimester was uncommon.

The prevalence odds ratios for any major birth defects after exposure to any newer-generation antiepileptic drugs during the first trimester were not statistically different for mothers with epilepsy, mood affective disorder or migraine, or without a diagnosis.

"Our study, to our knowledge, is the largest analytic cohort study on this topic and provides comprehensive safety information on a class of drugs commonly used during pregnancy. The use of lamotrigine and oxcarbazepine during the first trimester was not associated with moderate or greater risks of major birth defects like the older-generation , but our study cannot exclude a minor excess in risk of major birth defects or risks of specific birth defects. Topiramate, , and levetiracetam do not appear to be major teratogens [an agent that can cause malformations in an embryo or fetus], but our study cannot exclude minor to moderate risks of major ," the authors conclude.

More information: JAMA. 2011;305[19]1996-2002.

Related Stories

Recommended for you

Sugar not so sweet for mental health

July 27, 2017
Sugar may be bad not only for your teeth and your waistline, but also your mental health, claimed a study Thursday that was met with scepticism by other experts.

Could insufficient sleep be adding centimeters to your waistline?

July 27, 2017
Adults in the UK who have poor sleep patterns are more likely to be overweight and obese and have poorer metabolic health, according to a new study.

Vitamin E-deficient embryos are cognitively impaired even after diet improves

July 27, 2017
Zebrafish deficient in vitamin E produce offspring beset by behavioral impairment and metabolic problems, new research at Oregon State University shows.

The role of dosage in assessing risk of hormone therapy for menopause

July 27, 2017
When it comes to assessing the risk of estrogen therapy for menopause, how the therapy is delivered—taking a pill versus wearing a patch on one's skin—doesn't affect risk or benefit, researchers at UCLA and elsewhere ...

Blowing smoke? E-cigarettes might help smokers quit

July 26, 2017
People who used e-cigarettes were more likely to kick the habit than those who didn't, a new study found.

Brain disease seen in most football players in large report

July 25, 2017
Research on 202 former football players found evidence of a brain disease linked to repeated head blows in nearly all of them, from athletes in the National Football League, college and even high school.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.