What are the fetal risks of lamotrigine during pregnancy?

Answer

The North American Antiepileptic Drug (NAAED) pregnancy registry reported an elevated prevalence of isolated, nonsyndromic oral clefts in infants exposed to lamotrigine monotherapy during the first trimester as compared with a reference population.^[26]

A “Dear Health Professional” letter issued by the manufacturer reported 5 cases of oral clefts among 564 pregnancies exposed to lamotrigine during the first trimester, for a rate of 8.9 cases per 1000 pregnancies. The letter stated that this rate is 24 times higher than the prevalence of 0.37 cases per 1000 pregnancies in the general population of the surveillance program of Brigham and Women’s Hospital.

An FDA alert in September 2006, Information for Healthcare Professionals: Lamotrigine (marketed as Lamictal), (accessed March 30, 2011) stated the following:

“Preliminary data from the North American Antiepileptic Drug Pregnancy Registry suggest a possible association between exposure to lamotrigine monotherapy during the first trimester of pregnancy and cleft lip and/or cleft palate. The oral clefts reported were few and were not part of a syndrome that included other birth defects. Other pregnancy registries of similar size have not replicated this observation. The validity of this possible association cannot be established until further data are collected in the NAAED Pregnancy Registry, in other ongoing pregnancy registries, or through other research efforts. The clinical significance of this preliminary report is thus uncertain.”

The differences among the different series may be related to the levels of lamotrigine attained in the sera of the mothers and fetuses; presumably, teratogenicity is less with lower levels, but data confirming this hypothesis are lacking.

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Media Gallery

Magnetic resonance image showing multiple cortico-subcortical areas of hyperintense signal involving the occipital and parietal lobes bilaterally and pons in a patient with posterior reversible encephalopathy syndrome. Image courtesy of Wikimedia Commons.
This axial, T2-weighted brain magnetic resonance image (MRI) demonstrates an area of ischemia in the right periventricular white matter of a 41-year-old woman with longstanding systemic lupus erythematosus (SLE). She presented with headache and subtle cognitive impairments but no motor deficits. Faintly increased signal intensity was also seen on T1-weighted images, with a trace of enhancement following gadolinium that is too subtle to show on reproduced images. The distribution of the abnormality is consistent with occlusion of deep penetrating branches, such as may result from local vasculopathy, with no clinical or laboratory evidence of lupus anticoagulant or anticardiolipin antibody. Cardiac embolus from covert Libman-Sacks endocarditis remains less likely due to the distribution.
Axial T2 MRI showing an arteriovenous malformation, with hemorrhage, in the territory of the left posterior cerebral artery.
CT-scan of the brain with a RIGHT MCA infarct. Image courtesy of Wikimedia Commons.

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Author

Carmel Armon, MD, MSc, MHS Chair, Department of Neurology, Assaf Harofeh Medical Center, Tel Aviv University Sackler Faculty of Medicine, Israel

Carmel Armon, MD, MSc, MHS is a member of the following medical societies: American Academy of Neurology, American Academy of Sleep Medicine, American Association of Neuromuscular and Electrodiagnostic Medicine, American Clinical Neurophysiology Society, American College of Physicians, American Epilepsy Society, American Medical Association, American Neurological Association, American Stroke Association, Massachusetts Medical Society, Sigma Xi

Disclosure: Received research grant from: Neuronix Ltd, Yoqnea'm, Israel<br/>Received income in an amount equal to or greater than $250 from: JNS - Associate Editor. UpToDate - Author Royalties.

Coauthor(s)

George D Baquis, MD Assistant Professor of Neurology, Division of Neurology, Baystate Medical Center, Tufts University School of Medicine

Disclosure: Nothing to disclose.

George F Howard III, MD Consulting Staff, Sleep Medicine Services of Western Massachusetts, LLC

George F Howard III, MD is a member of the following medical societies: American Academy of Neurology, American Clinical Neurophysiology Society, American Epilepsy Society, American Medical Association, Massachusetts Medical Society, American Academy of Sleep Medicine

Disclosure: Nothing to disclose.

Philip S Hsu, MD Assistant Professor of Neurology, Tufts University School of Medicine; Director of Neurology Education, Division of Neurology, Baystate Medical Center

Philip S Hsu, MD is a member of the following medical societies: American Academy of Neurology, American Association of Neuromuscular and Electrodiagnostic Medicine

Disclosure: Nothing to disclose.

Karin Gardner Johnson, MD Assistant Professor of Medicine, Tufts University Medical School; Attending Neurologist, Baystate Medical Education and Research Foundation, Baystate Medical Center

Karin Gardner Johnson, MD is a member of the following medical societies: American Academy of Neurology, American Academy of Sleep Medicine

Disclosure: Nothing to disclose.

Melanie J Krupa, PA-C Physician Assistant, Hampden County Physician Associates

Melanie J Krupa, PA-C is a member of the following medical societies: American Academy of Physician Assistants

Disclosure: Nothing to disclose.

Glenn R Markenson, MD Associate Professor of Obstetrics and Gynecology, Tufts University School of Medicine; Chief of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baystate Medical Center, Medical Director, Human Research Protection Program, Baystate Health

Glenn R Markenson, MD is a member of the following medical societies: American College of Obstetricians and Gynecologists, American Institute of Ultrasound in Medicine, American Medical Association

Disclosure: Nothing to disclose.

Chief Editor

Stephen A Berman, MD, PhD, MBA Professor of Neurology, University of Central Florida College of Medicine

Stephen A Berman, MD, PhD, MBA is a member of the following medical societies: Alpha Omega Alpha, American Academy of Neurology, Phi Beta Kappa

Disclosure: Nothing to disclose.

Acknowledgements

Jose E Cavazos, MD, PhD, FAAN Associate Professor with Tenure, Departments of Neurology, Pharmacology, and Physiology, Program Director of the Clinical Neurophysiology Fellowship, University of Texas School of Medicine at San Antonio; Co-Director, South Texas Comprehensive Epilepsy Center, University Hospital System; Director of the San Antonio Veterans Affairs Epilepsy Center of Excellence and Neurodiagnostic Centers, Audie L Murphy Veterans Affairs Medical Center

Jose E Cavazos, MD, PhD, FAAN is a member of the following medical societies: American Academy of Neurology, American Clinical Neurophysiology Society, American Epilepsy Society, and American Neurological Association

Disclosure: GXC Global, Inc. Intellectual property rights Medical Director - company is to develop a seizure detecting device. No conflict with any of the Medscape Reference articles that I wrote or edited.

Christopher Luzzio, MD Clinical Assistant Professor, Department of Neurology, University of Wisconsin at Madison School of Medicine and Public Health

Christopher Luzzio, MD is a member of the following medical societies: American Academy of Neurology

Disclosure: Nothing to disclose.

Francisco Talavera, PharmD, PhD Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy; Editor-in-Chief, Medscape Drug Reference

Disclosure: Medscape Salary Employment

Acknowledgments

This article is a collaborative effort of current and former members of the Division of Neurology at Baystate Medical Center, Springfield, Massachusetts.

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