Advantages and problems with pregnancy registries: observations and surprises throughout the life of the International Lamotrigine Pregnancy Registry

Author:

Sinclair Susan12,Cunnington Marianne3,Messenheimer John4,Weil John3,Cragan Janet5,Lowensohn Richard6,Yerby Mark7,Tennis Patricia8

Affiliation:

1. University of North Carolina Wilmington; Wilmington NC USA

2. INC Research LLC; Wilmington NC USA

3. Worldwide Epidemiology; GlaxoSmithKline; Uxbridge UK

4. Clinical Development; GlaxoSmithKline; Research Triangle Park NC USA

5. National Center on Birth Defects and Developmental Disabilities; Centers for Disease Control and Prevention; Atlanta GA USA

6. Oregon Health and Science University; Portland OR USA

7. North Pacific Neurological Research; Portland OR USA

8. RTI International; Research Triangle Park NC USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference44 articles.

1. United States Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Centers for Biologic Evaluation and Research Guidance for industry http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071639.pdf

2. European Medicines Agency Guideline on the exposure to medicinal products during pregnancy; need for post-authorisation data http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/11/WC500011303.pdf

3. How common are the “common” neurologic disorders?;Hirtz;Neurology,2007

4. Development and growth in children of epileptic mothers: a prospective controlled study;Gaily;Acta Obstet Gynecol Scand,1991

5. The teratogenicity of anticonvulsant drugs;Holmes;N Engl J Med,2001

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