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Welcome! This information is intended only for healthcare providers who:
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 LYMErix® vaccine pregnancy registry is managed by GlaxoSmithKline's Global Clinical Safety and Pharmacovigilance department, which 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 Pregnancy Registries (Final Study Report Available): |
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