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Drug safety in pregnancy: Utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services

Authors

  • Christof Schaefer

    1. Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Berlin, Germany
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  • Presented at the 50th Anniversary Meeting of the Japanese Teratology Society, Awaji Island, July, 2010.

Christof Schaefer, MD, PhD, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Haus 10, 14050 Berlin, Germany. Email: schaefer@embryotox.de

ABSTRACT

Even though from preclinical testing to drug risk labeling, the situation with drugs in pregnancy has improved substantially since the thalidomide scandal, there is still an increasing need to provide healthcare professionals and patients with updated individualized risk information for clinical decision making. For the majority of drugs, clinical experience is still insufficient with respect to their safety in pregnancy. There is often uncertainty in how to interpret the available scientific data. Based on 20 years of experience with Teratology Information Services (TIS) cooperating in the European Network of Teratology Information Services (ENTIS) methods of risk interpretation, follow-up of exposed pregnancies through the consultation process and their evaluation is discussed. Vitamin K antagonists, isotretinoin and angiotensin (AT) II-receptor-antagonists are presented as examples of misinterpretation of drug risks and subjects of research based on observational clinical data recorded in TIS. As many TIS are poorly funded, advocacy is necessary by establishing contacts with decision makers in health politics and administration, informing them of the high return in terms of health outcomes and cost savings provided by TIS as reference institutions in clinical teratology.

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