Monitoring Outcomes of Pregnancy Following Drug Exposure

  title={Monitoring Outcomes of Pregnancy Following Drug Exposure},
  author={Kristine E. Shields and B-E. Wiholm and Robert G. Sharrar and Linda S. Hostelley and Linda F. Striano and Sam R. Arena},
  journal={Drug Safety},
Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. However, there are limited data available to inform decision-making. The Merck Pregnancy Registry Program is a company-run pregnancy registry whose objective is to acquire and analyse… 

Monitoring for teratogenic signals: Pregnancy registries and surveillance methods

Combinations of different sources of data are necessary to acquire the most complete picture of potential teratogenic risk, as no single method can capture all desired data to help pregnant patients and women of child bearing potential make appropriate risk benefits decisions along with their health care providers.

Development of Drug Exposure Registries on Pregnant Women

Information on pregnancy drug exposure in Korea can be effectively collected by using this report which provides a comprehensive assess to drug’s influence on pregnant women and fetus.

Medication use during pregnancy and lactation: an urgent call for public health action.

A comprehensive, coordinated public health approach that builds on and expands existing activities is needed to generate information about medication use, make that information readily available, and translate it into safe and effective healthcare.

Medication exposure during pregnancy: a pilot pharmacovigilance system using health and demographic surveillance platform

Almost all women were exposed to medication during pregnancy and antimalarial and antibiotic exposures in pregnancy were not significantly associated with adverse pregnancy outcome, and iron and folic acid supplementation were associated with decreased risk of miscarriage/stillbirth.

Bias Against the Null Hypothesis in Retrospective Registries of Gestational Drug Exposure.

  • F. EtwelG. Koren
  • Medicine
    Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC
  • 2016


It is essential to develop standards for assessing and reporting antenatal exposures to refine any future research in this field, and use of drugs by therapeutic categories and by potential for fetal risk is considered while updating this review.

Olanzapine in pregnancy and breastfeeding: a review of data from global safety surveillance

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Safety Profile of Drug Use During Pregnancy at Peripheral Health Centres in Burkina Faso: A Prospective Observational Cohort Study

The safety profile of drugs used in women at high risk of malaria during pregnancy and delivery in Burkina Faso and the need for rational drug prescription and community education to reduce hazardous drug exposure during pregnancy are suggested.

Pharmacotherapy and Pregnancy: Highlights from the Third International Conference for Individualized Pharmacotherapy in Pregnancy

The Conference highlighted several areas of collaboration within the current Obstetrics Pharmacology Research Units Network and hoped to educate providers, researchers, and agencies with the common goal to improve the ability to safely and effectively use individualized pharmacotherapy in pregnancy.



Pharmacist's guide to pregnancy registry studies.

Evaluation of selected characteristics of pregnancy drug registries.

If registries improve their ascertainment of defects and exposed pregnancies, they will increase their chance of detecting signs of possible teratogenicity, and HIV surveillance identified 300 prenatal zidovudine exposures, while the registry received 134 worldwide reports.

Review of pregnancy labeling of prescription drugs: is the current system adequate to inform of risks?

The difficulties that are associated with the assessment of the benefits/risks of drug therapy during pregnancy are outlined, the history of the Food and drug Administration regulations for labeling prescription drugs, and the strengths and weaknesses of the current Food and Drug Administration pregnancy labeling system are reviewed.

Delivery outcome after the use of antidepressants in early pregnancy

The use of antidepressants in early pregnancy does not seem to carry any significant risk for the infant that is detectable during the newborn period, based on this database.

FDA Labeling System for Drugs in Pregnancy

The proposed pregnancy labeling system strives for more clinical usefulness by reliance on human data derived from pregnancy registries, and the clinical usefulness of the new labeling remains to be seen.

Pharmacoepidemiologic implications of erroneous varicella vaccinations in pregnancy through confusion with Varicella zoster immune globulin

The persistent problem of inadvertent administrations during pregnancy of this live virus product instead of the intended Varicella zoster immune globulin warrants specific educational efforts to prevent further repetitions and has more general implications for medical product safety surveillance.

Asthma and pregnancy

Spontaneous Abortions: Epidemiology

Between 10% and 20% of recognised pregnancies are spontaneously aborted, mostly some time after fetal death has occurred, and better estimates are now becoming possible using information from studies of in-vitro fertilisation and from the use of very sensitive early pregnancy tests.

Foundations of Epidemiology

This introductory text gives an exceptionally clear and well organized account of epidemiologic concepts and methods, emphasizing the sequence of reasoning from different types of data that lead to