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 teratogenic risk in human pregnancy was "undetermined" for 168 (97.7%) of drug treatments approved between 2000 and 2010. Furthermore, the amount of data available regarding safety in pregnancy was rated as "none" for 126 (73.3%) of these drugs. For those drugs approved between 1980 and 2000, only 23 (5%) changed a full risk category or more in the past 10 years. Sources of data that led to a revised risk were derived from exposure cohort studies performed through record linkage studies, teratogen information services, large population-based case-control studies, and pregnancy registries. The mean time for a treatment initially classified as having an "undetermined" risk to be assigned a more precise risk was 27 years (95% confidence interval 26-28 years). The lack of information needed to assess the safety of drug treatments during human pregnancy remains a serious public health problem. A more active approach to post-marketing surveillance for teratogenic effects is necessary.

Evolving knowledge of the teratogenicity of medications in human pregnancy

Background Perception of risk may impact a woman’s decision to take a needed drug during pregnancy. There is a paucity of research on this topic in the literature. Objectives (1) To evaluate the perception of risk of 17 commonly used drugs and other substances by pregnant women. (2) To investigate which sources of information regarding exposures during pregnancy were most commonly used by women. Methods A questionnaire was developed through the University of Oslo’s website for Internet surveys and posted on four Web pages used by pregnant women and mothers, from mid-September 2008 through October 2008. The inclusion criteria included women who were (1) pregnant or 2) a mother of a child less than 5 years old. Results A total of 1,793 eligible women completed the questionnaire. Most women overestimated the teratogenic risk associated with all the drugs during pregnancy. Characteristics of the women that were associated with a high perception of risk were primiparity, higher age, higher education, and choosing not to use a drug during pregnancy. More than 80% of the women had used drugs during pregnancy, mostly paracetamol, penicillins and reflux medications. The physician, the product information leaflet and the pharmacist were the three most frequently used sources of information. Conclusion Women overestimate the risk of drug use and other exposures during pregnancy. Therefore, it is important for health care providers to use evidence-based information, to reduce unnecessary anxiety, and to ensure safe and appropriate treatment during pregnancy.

Perception of risk regarding the use of medications and other exposures during pregnancy.

https://jdc.jefferson.edu/cgi/viewcontent.cgi?article=1023&context=robert_brent

Saving lives and changing family histories: appropriate counseling of pregnant women and men and women of reproductive age, concerning the risk of diagnostic radiation exposures during and before pregnancy

Lymphoma is the fourth most frequent malignancy diagnosed during pregnancy, occurring in approximately 1:6000 of deliveries. Its occurrence may increase due to the current trend to postpone pregnancy until later in life and the suggested high incidence of AIDS-related non-Hodgkin's lymphoma in developing countries. The relatively rare occurrence of pregnancy-associated lymphoma precludes the conduction of large, prospective studies to examine diagnostic, management and outcome issues. Chemotherapy and radiotherapy during the first trimester are associated with increased risk of congenital malformations and this risk diminishes as pregnancy advances. In the vast majority of cases, when lymphoma is diagnosed during the first trimester, treatment with a standard chemotherapy regimen, following pregnancy termination should be recommended. In the rare patients at low risk, such as those with stage 1 Hodgkin's lymphoma or indolent non-Hodgkin's lymphoma, therapy can be delayed until the end of the first trimester and of embryogenesis while keeping the patients under close observation. When lymphoma is diagnosed during the second and third trimesters, evidence exists suggesting that full-dose chemotherapy can be administered safely without apparent increased risk of severe adverse fetal outcome.

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The treatment of Hodgkin's and non-Hodgkin's lymphoma in pregnancy.

Most autoimmune and systemic inflammatory diseases are more common in women than in men, including women of child-bearing age. Therefore, for many of our patients, family planning is an important clinical issue. The management of pregnancy in autoimmune diseases is complex, benefitting optimally from a multidisciplinary approach that takes into consideration: prepregnancy counseling; treatments received prior to, during, and after pregnancy; early recognition of both obstetric complications and medical complications relating to the underlying disease; prenatal fetal development; and postnatal management of the

https://onlinelibrary.wiley.com/doi/pdf/10.1002/acr.22516

Proceedings From the American College of Rheumatology Reproductive Health Summit: The Management of Fertility, Pregnancy, and Lactation in Women With Autoimmune and Systemic Inflammatory Diseases

Significant numbers of therapeutic abortions are performed for radiation-exposed pregnant women because of concerns about the teratogenic risk. However, available data suggest that current diagnostic radiation procedures are not teratogenic.

Ronnen Maze

Papers

Diagnostic Radiation in Pregnancy: Perception Versus True Risks