Assessment of developmental risk information on medicines for inclusion on the WHO's Essential Medicines List.

Background: The WHO develops biannually an Essential Medicines List (EML) of medications proposed for national formularies to be safe, effective and cost-effective. This satisfies the priority healthcare needs of most adult populations, but it does not consider the unique toxicological risks that occur from exposures during pregnancy.

Methods: Developmental toxicity risk information for the 451 specific agents on the 2017 EML were identified from four well-recognized compendia of teratological assessments.

Exploring the Design and Role of Mobile Apps for Healthcare Providers to Find Teratogenic Information.

Healthcare providers (HCPs) caring for pregnant patients often need information on drug risks to the embryo or fetus, but such complex information takes time to find and is difficult to convey on an app. In this work, we first surveyed 167 HCPs to understand their current teratogen information-seeking practices to help inform our general design goals. Using the insights gained, we then designed a prototype of a mobile app and tested it with 22 HCPs.

Thomas H. Shepard, M.D., pioneer in embryology and teratology.

Dr. Thomas H. Shepard died on October 3, 2016 at the age of 93.

Should pregnant women be included in phase IV clinical drug trials?

Relatively few drugs, especially those recently approved by the US Food and Drug Administration, have published human pregnancy experience. Although all drugs contain animal reproduction data, these are usually not predictive of human risk. Clinical trials in pregnant women are rarely conducted because of ethical and legal concerns, and it may be many years before sufficient observational data are collected to guide clinical treatment decisions.

Is there an embryopathy associated with first-trimester exposure to angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists? A critical review of the evidence.

Drugs that interfere with the renin-angiotensin system, such as angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), are widely used to manage hypertension and heart failure. Adequate functioning of the RAS is essential for normal fetal kidney development. The potential for ACEIs and ARBs to impair fetal and neonatal renal function if taken after the first trimester of pregnancy has been well documented.

Reliability and validity of the 4-item perceived stress scale among pregnant women: results from the OTIS antidepressants study.

We aimed to estimate the reliability of the 4-item Perceived Stress Scale (PSS) and its validity in predicting maternal depression and quality of life (QoL). Data regarding stress, depression and QoL were collected during pregnancy among a sub-sample from the Organization of Teratology Information Specialists Antidepressants in Pregnancy Cohort. The 4-item PSS demonstrated acceptable internal consistency (Cronbach's alpha coefficient = .

Evolving knowledge of the teratogenicity of medications in human pregnancy.

A majority of pregnant women take at least one medication during pregnancy, although the safety of such drugs during pregnancy is not always known. We reviewed the safety during pregnancy of 172 drugs approved by the US Food and Drug Administration (FDA) from 2000 to 2010 using the TERIS risk rating system. We also reviewed safety information for 468 drugs approved by the FDA from 1980 to 2000 to determine if revisions in risk categories had been made in the last 10 years.

The art and science of teratogen risk communication.

Despite scientific advances in clinical teratology, exposures during pregnancy still cause great anxiety and misunderstanding. Patients and health care providers are frequently called upon to determine the health implications of scientific studies, which may involve limited and contradictory data. These findings are often conveyed numerically, which is a particularly difficult form of information for both patients and their health providers to understand and interpret.

Safety of dermatologic drugs used in pregnant patients with psoriasis and other inflammatory skin diseases.

In patients with psoriasis, there is an increased availability of drugs for treatment. However, there are important questions about drug safety for mothers with psoriasis and their fetuses. Currently, there are limited safety data for many of the medications used.

A survey of pregnant women using isotretinoin.

Background: Isotretinoin is a known human teratogen, causing birth defects and/or subnormal cognitive performance in prenatally-exposed children.

Methods: A survey was conducted among women who called teratology information services throughout North America. Using a structured questionnaire, women with an isotretinoin-exposed pregnancy were prospectively interviewed before the outcome of the pregnancy was known.

Medical genetics: 1. Clinical teratology in the age of genomics.

Teratogenic exposures are those that can cause an embryo or fetus to develop abnormally. Several factors determine whether an agent is teratogenic, including the gestational timing of the exposure, as well as the dose, route and nature of the agent itself. We review the general concepts of teratogenesis, as well as known genetic susceptibilities to teratogenic effects, with a special focus on antiepileptic drugs.

Developmental toxicity: web resources for evaluating risk in humans.

This review presents a brief overview of Internet resources that provides information on developmental toxicity. The advantages and limitations of these resources for evaluating human risk and where each one is useful for informing various stages of the risk assessment process (i.e.