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DRUG PREGNANCY REGISTRIES Jan Cragan, M.D.

DRUG PREGNANCY REGISTRIES Jan Cragan, M.D. 1-800-336-2176 Antiretroviral Pregnancy Registry Lamotrigine Pregnancy Registry Sumatriptan Pregnancy Registry Bupropion Pregnancy Registry 1-888-233-2334 Antiepileptic Drug (AED) Pregnancy Registry

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DRUG PREGNANCY REGISTRIES Jan Cragan, M.D.

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  1. DRUG PREGNANCY REGISTRIESJan Cragan, M.D. • 1-800-336-2176 Antiretroviral Pregnancy Registry Lamotrigine Pregnancy Registry Sumatriptan Pregnancy Registry Bupropion Pregnancy Registry • 1-888-233-2334 Antiepileptic Drug (AED) Pregnancy Registry • 1-800-986-8999 Pregnancy Registry for VARIVAX

  2. DRUG PREGNANCY REGISTRIESStrengths • Shift in industry focus toward actively monitoring for adverse effects of drug use in pregnancy • Prospective ascertainment reduces selection bias and allows calculation of the risk of adverse outcomes • Increased statistical power to identify defects resulting from individual drug exposures

  3. DRUG PREGNANCY REGISTRIESLimitations • Difficulty in obtaining sufficient sample size to evaluate changes in individual defect rates • Lack of a control group • Quality of exposure and outcome data • Confidentiality issues

  4. CONSIDERATIONS FOR DEVELOPMENTOF A CENTRAL PREGNANCY REGISTRY • Definition of a central registry • Data to be collected • Administration and funding • Is a central registry worth the effort?

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