The new FDA labeling rule: impact on prescribing rheumatological medications during pregnancy.

After several decades of deliberation, the US Food and Drug Administration updated the Pregnancy and Lactation Labeling Rule in 2015, eliminating the prior A, B, C, D, X grading system for medication use in pregnancy. Although physicians and patients liked the relative ease of use of this system, it was often misconstrued and not updated to include new data suggesting greater compatibility of medications with pregnancy. The new label is designed to include more clinically relevant data, including data from human studies and registries, and fewer animal data. A key goal of the new label is to assist physicians and patients as they weigh the risks and benefits of medications vs the risks of pregnancy in a woman with a chronic, untreated illness. As such, each label now includes a section outlining the pregnancy risks of the diseases that the medication treats. This review includes a historical perspective on the label change and a guide to the interpretation of the new label. It also includes an assessment of the baseline risk of pregnancy in women with SLE and RA, to help balance the consideration of medication risks and benefits in pregnancy.

Implementation, mechanisms and effects of maternity protection legislation: a realist narrative review of the literature.

PURPOSE: Most industrialized countries have introduced maternity protection legislation (MPL) to protect the health of pregnant workers and their unborn children from workplace exposure. This review aimed to assess this legislation's level of implementation, barriers and facilitators to it, and its expected or unexpected effects. METHODS: A realist narrative review was conducted. Keyword searches of the PubMed, CINAHL, PsycINFO, MIDIRS, Sociological abstracts and Google Scholar electronic databases were performed in March 2018. RESULTS: The 42 publications included show that the implementation of MPL is deficient in most countries. Allowing pregnant women to withdraw from work on preventive leave or sick leave is favored over workplace adaptations or worker reassignments. The publications highlight mechanisms which encourage or obstruct the enforcement of legislation at the levels of the individual, the physical and social environment, and the macrosocial context. The delay between the conception and implementation of maternity protection measures appears to be a major barrier to the efficacy of MPL. The literature also suggests that unexpected adverse effects, such as degradation in working relationships or discrimination can obstruct the implementation of protective measures. CONCLUSIONS: This study showed the need for a better implementation of MPL during pregnancy. Further research and recommendations for improvements in MPL should consider the diverse mechanisms and effects of its implementation. Barriers and adverse effects of this implementation do not only ensure a lack of information or awareness about MPL, but are also linked to contradictions between requirements to protect employment and protect pregnancy.

Protection of pregnant women at work in Switzerland: practices, obstacles and resources. A mixed-methods study protocol.

INTRODUCTION: Like most industrialised countries, Switzerland has introduced legislation to protect the health of pregnant workers and their unborn children from workplace exposure. This legislation provides for a risk assessment, adaptations to workplaces and, if the danger is not eliminated, preventive leave (prescribed by a gynaecologist). This study's first objective is to analyse the degree to which companies, gynaecologists and midwives implement the law. Its second objective is to understand the obstacles and resources of this implementation, with a focus on how relevant stakeholders perceive protective measures and their involvement with them. METHODS AND ANALYSIS: Data will be collected using mixed methods: (1) online questionnaires for gynaecologists and midwives; telephone questionnaires with company human resources (HR) managers in the healthcare and food production sectors; (2a) case studies of 6-8 companies in each sector, including interviews with stakeholders such as women workers, HR managers and occupational health physicians; (2b) two focus groups, one involving occupational physicians and hygienists, one involving labour inspectors.Quantitative data will be analysed statistically using STATA software V.15. Qualitative data will be transcribed and thematically analysed using MaxQDA software. ETHICS AND DISSEMINATION: The Human Research Ethics Committee of the Canton Vaud (CER-VD) has certified that this research study protocol falls outside of the field of application of the Swiss Federal Act on Research Involving Humans.The publications and recommendations resulting from this study will form the starting point for future improvements to the protection of pregnant women at work and their unborn children.This study started in February 2017 and will continue until January 2020.

COMPUTATIONAL ASSESSMENT OF PREGNANT WOMAN MODELS EXPOSED TO UNIFORM ELF-MAGNETIC FIELDS: COMPLIANCE WITH THE EUROPEAN CURRENT EXPOSURE REGULATIONS FOR THE GENERAL PUBLIC AND OCCUPATIONAL EXPOSURES AT 50 Hz.

The Recommendation 1999/529/EU and the Directive 2013/35/EU suggest limits for both general public and occupational exposures to extremely low-frequency magnetic fields, but without special limits for pregnant women. This study aimed to assess the compliance of pregnant women to the current regulations, when exposed to uniform MF at 50 Hz (100 µT for EU Recommendation and 1 and 6 mT for EU Directive). For general public, exposure of pregnant women and fetus always resulted in compliance with EU Recommendation. For occupational exposures, (1) Electric fields in pregnant women were in compliance with the Directive, with exposure variations due to fetal posture of <10 %, (2) electric fields in fetuses are lower than the occupational limits, with exposure variations due to fetal posture of >40 % in head tissues, (3) Electric fields in fetal CNS tissues of head are above the ICNIRP 2010 limits for general public at 1 mT (in 7 and 9 months gestational age) and at 6 mT (in all gestational ages).

Environmental perchlorate exposure: potential adverse thyroid effects.

PURPOSE OF REVIEW: This review will present a general overview of the sources, human studies, and proposed regulatory action regarding environmental perchlorate exposure. RECENT FINDINGS: Some recent studies have reported significant associations between urinary perchlorate concentrations, thyroid dysfunction, and decreased infant intelligence quotient in groups who would be particularly susceptible to perchlorate effects. An update regarding the recently proposed regulatory actions and potential costs surrounding amelioration of perchlorate contamination is provided. SUMMARY: The potential adverse thyroidal effects of environmental perchlorate exposure remain controversial, and further research is needed to further define its relationship to human health among pregnant and lactating women and their infants.

Lead, cadmium and mercury levels in pregnancy: the need for international consensus on levels of concern.

For heavy metals that have any degree of transfer though the placenta to the fetus, it is unlikely that there are safe limits for maternal blood levels. The only means of reducing fetal exposure is to minimise maternal exposure. There are few recommendations for levels of concern. With the exception of US recommendations for maternal Pb levels, but there are no international levels of concern or cut-off levels specifically for pregnancy for heavy metals, so that comparisons can generally only be made with national reference values relating to similar physiological statuses or age groups. These include recommendations for Cd levels by Germany (reference value for non-smoking adults aged 18-69 years, 1 µg/l) and for Hg by Germany (reference value for adults age 18-60 years with fish intake < or =3 times per month, 2.0 µg/l) and the USA (cut-off level for women, 5.8 µg/dl). To illustrate the lack of cohesion, we present data on blood Pb, Cd and Hg levels from pregnant women enroled in the UK Avon Longitudinal Study of Parents and Children study and compare the values with present levels of concern and recommended cut-off values. We also compare the levels with those found in other groups of pregnant women worldwide to strengthen the database for the development of levels of concern in pregnancy. The need for clarity of terminology in describing levels of concern is discussed. There is a pressing need for international consensus on levels of concern for all age groups and physiological statuses, particularly for pregnancy.

Prevention of and response to inadvertent exposure of embryo/fetus to ionizing radiation, due to medical exposure of the mother. The Greek regulatory authority initiatives.

Embryo/fetus (E/F) irradiation as a result of medical exposure of the mother should be avoided, unless there are strong clinical indications. Medical practitioners are assigned the primary task and obligation of ensuring overall patient protection and safety in the prescription of and during the delivery of medical exposure. In cases of unintended exposure of embryo/fetus (E/F), the risk analysis and communication is conducted by or under the supervision of medical physicists at local level. National competent authorities can contribute to the prevention, risk analysis and communication of inadvertent E/F exposure to ionizing radiation by recording, analyzing and disseminating the relevant information. Since 2001, Greek Atomic Energy Commission has established a committee with the mandate to provide advice, to keep records, to analyze and disseminate the experience gained in cases of unintended E/F exposure. During the period 2001-2011, the committee was consulted by 269 pregnant women undergone medical exposures. The conclusions from the relevant data analysis, as well as the experience gained are herein presented and discussed.

Influence of maternal toxicity on the outcome of developmental toxicity studies.

The relevance of fetal abnormalities noted at maternally toxic doses is a long-standing issue regarding the interpretation of findings of segment II studies. A number of diseases and conditions during pregnancy are known to adversely affect embryo/fetal development, and along this line many scientists believe that any marked disturbance of maternal homeostasis produced by chemical exposure may eventually produce a teratogenic effect. Although there is little doubt that developmental toxicity may be maternally mediated, the notion that, in principle, any maternal toxicity leads to birth defects is disputed. When embryotoxicity is noted only within the maternally toxic dose range, it is not possible to ascertain whether it is in fact maternally mediated or not (i.e., embryo development may have been impaired by a direct action of the chemical at doses that also adversely affect the mother; in these circumstances it would still be a selective developmental toxicant). However, currently, a chemical is not regarded as a "developmental toxicant" (or "teratogenic agent") if embryotoxicity is apparent only at doses that are also toxic to the mother. In the European Union, developmental hazard identification exerts a strong influence on the classification and labeling of chemicals. In Brazil, registration of any pesticide that proved to be teratogenic in animal studies is strictly forbidden by law (Pesticide Law, Federal Law 7.802, 1989). Therefore, interpretation of findings from developmental toxicity studies in light of maternal toxicity is particularly relevant to regulatory agencies, and becomes even more important when labeling or cutoff decision-making criteria are adopted regarding teratogenicity.

The impact of secondhand smoke during pregnancy.

No one disputes the adverse effects of smoking. Pregnant women should not smoke, as study after study proves the serious damage done by exposure to tobacco. Understanding the deadly effects of secondhand smoke has led to legislation by countries and individual states in the United States. Around the world, countries including England, Ireland, Italy, France and Uruguay have banned smoking from all public places. In the United States, 26 states to date have adopted comprehensive clean air acts, including Nebraska, Iowa and Minnesota. At the time this article went to print, South Dakota's smoke-free legislation, which will ban smoking in all indoor public places except smoke shops, existing cigar bars and lodging rooms, was to take effect July 1, 2009.

Workplace standards for exposure to toxicants during pregnancy.

Many women of childbearing age are exposed to reproductive toxicants in the workplace. This article highlights the need for an evaluation of current occupational exposure guidelines for pregnant women working with hazardous agents that have the potential of being reproductive toxins. Limited information regarding reproductive risks associated with many chemicals in the workplace presents challenges in the establishment of standards that are 'safe' for vulnerable populations, such as the fetus. The management of these risks must take into consideration the limitations of available knowledge as well as individual risk factors that may amplify the likelihood of adverse outcomes. In 1981, Quebec adopted a policy that provides "precautionary leave" or reassignment of pregnant workers to other jobs if they are exposed to a factor suspected to compromise their health or that of their fetus during pregnancy. The advantages and disadvantages of this approach to managing reproductive hazards are discussed. The existence of a regulatory safety net at the level of the workplace for minimizing the impact of toxicant exposure on reproductive health outcomes is stressed. Management options that can be implemented early to provide added protection when a hazard cannot be reduced or eliminated are recommended.

The politics of reproductive hazards in the workplace: class, gender, and the history of occupational lead exposure.

Over the past two decades, several U.S. companies have sought to bar women from jobs that expose them to potential reproductive hazards, justifying these exclusionary policies by their professed concerns for the well-being of unborn children and potential liability. Although recent court cases have stimulated academic interest in this issue, a historical review of the public health and medical literature reveals that this debate is not new. To understand the logic behind the emergence of "fetal protection" policies, one must examine the scientific history of occupational teratogens and the socio-political and economic forces that have driven scientific research in this field. Using lead as an example, the author argues that research on the reproductive hazards of employment has historically emphasized the risks to women and downplayed the risks to men. This results in environmental health policies that do not uphold the ultimate goal of occupational safety for all workers, but rather reinforce the systemic segregation of men and women in the workplace. Although the political struggle over exclusionary policies has a feminist orientation, it also has important class dimensions and ultimately must be viewed within the broader context of American capitalist production.

Health risks associated with prenatal metal exposure.

A symposium entitled Health Risks Associated with Prenatal Metal Exposure was held at the 33rd Annual Meeting of the Society of Toxicology (SOT) in Dallas, Texas. The symposium was cosponsored by the Metals and Reproductive and Developmental Specialty Sections of SOT and was designed to elaborate the health risks associated with in utero exposure to metals commonly found in the workplace and/or ambient environment on the mother and developing offspring. Epidemiological and toxicological evidence that demonstrates the health effects and underlying mechanisms associated with exposure to arsenic (As), lead (Pb), and methyl mercury (MeHg) were discussed, as well as the legal ramifications and personal implications associated with prenatal metal exposure. The following is a summary of each of the individual presentations.