This information on drug pregnancy registries is intended only for healthcare providers who:
The information on vaccine pregnancy registries is intended for patients (consumers) and healthcare providers, who, before any knowledge of the pregnancy outcome, wish to enroll a pregnancy already exposed to a certain vaccine into an exposure registry.
The safety of the products (listed below) during pregnancy has not been established, and no adequate human studies have been performed. None of these products, except RETROVIR® (zidovudine, AZT) after the first trimester, is approved for use during pregnancy. Except for RETROVIR®, these products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The drug pregnancy registries are observational studies being conducted by GlaxoSmithKline Group Medical Operations, in consultation with the Centers for Disease Control and Prevention (CDC), to track the effects of certain prescription drugs on pregnancy outcomes when mothers have been exposed to the drugs at any time during pregnancy. GlaxoSmithKline has engaged Kendle International Inc. to assist with the administrative activities of the specific drug pregnancy registries. The vaccine pregnancy registries are programs of enhanced surveillance. They are managed by GlaxoSmithKline's Biological Clinical Safety and Pharmacovigilance department, and GSK should be contacted directly for patient registration and information. These studies (referred to as pregnancy registries) are ongoing, and enrollment of pregnant women already exposed to these products is encouraged. Interim results from the drug pregnancy registries are available to healthcare providers to supplement animal toxicology studies and to assist clinicians in caring for their patients.
Ongoing Pregnancy Registries:
(closed for enrollment 31 January 2012)
Closed Pregnancy Registries (Final Study Report Available):