Teratogenicity of recently introduced medications in human pregnancy

Lo, Wenpin; Friedman, Jan M.

doi:10.1016/s0029-7844(02)02122-1

Cited by 112 publications

(43 citation statements)

References 20 publications

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“…Indeed, a 2002 review of fetal risk associated with all 468 of the medications approved in the United States for use in humans between 1980 and 2000 revealed just how little we know (Lo and Friedman 2002). Only 6.4 percent were recognized as safe in pregnancy (in that their teratogenic risk was considered as “none, minimal or unlikely”); and 2.5 percent were associated with some risk, ranging from small or moderate (fetal growth restriction with cyclophosphamide chemotherapy, goiter with amiodarone) to high (severe limb abnormalities with thalidomide).…”

Section: The Costs Of Exclusionmentioning

confidence: 99%

See 1 more Smart Citation

The second wave: Toward responsible inclusion of pregnant women in research

Lyerly¹,

Little²,

Faden³

2008

IJFAB: International Journal of Feminist Approaches to Bioethic

121

100

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Though much progress has been made on inclusion of non-pregnant women in research, thoughtful discussion about including pregnant women has lagged behind. We outline resulting knowledge gaps and their costs and then highlight four reasons why ethically we are obliged to confront the challenges of including pregnant women in clinical research. These are: the need for effective treatment for women during pregnancy, fetal safety, harm from the reticence to prescribe potentially beneficial medication, and the broader issues of justice and access to benefits of research participation. Going forward requires shifting the burden of justification from inclusion to exclusion and developing an adequate ethical framework that specifies suitable justifications for excluding pregnant women from research.

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Section: The Costs Of Exclusionmentioning

confidence: 99%

“…Worse, this percentage has shifted very little over the last two decades. More than 80 percent of drugs are classified as “undetermined” with respect to fetal risk, whether approved 15–20 years ago (96%), 10–14 years ago (83%), 5–9 years ago (88%), or 0–4 years ago (95%) (Lo and Friedman 2002). …”

Section: The Costs Of Exclusionmentioning

confidence: 99%

The second wave: Toward responsible inclusion of pregnant women in research

Lyerly¹,

Little²,

Faden³

2008

IJFAB: International Journal of Feminist Approaches to Bioethic

121

100

View full text Add to dashboard Cite

show abstract

“…However, the changing landscape of maternal exposures makes continued clinical, surveillance, and research vigilance necessary. For example, new medications enter the market every year, the vast majority of which have insufficient clinical or epidemiological data to determine teratogenic risk [99, 100]; in addition, existing medications may be approved for new indications or used off label for a wider range of conditions [101]. Further, although the prevalence of traditional smoking has decreased over time, the introduction and increasing use of the e-cigarette may increase the exposure to nicotine during pregnancy [102].…”

Section: Challenges In Translationmentioning

confidence: 99%

Challenges in Studying Modifiable Risk Factors for Birth Defects

et al. 2014

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Conducting research to identify modifiable risk factors for birth defects is difficult for a variety of reasons. While some challenges are familiar to researchers across many disciplines, the confluence of issues affecting birth defects research may not be well understood by those outside of the field. This article describes several methodological challenges to the study of birth defects and ways these challenges might be addressed: (1) ascertainment, definition and classification of birth defects; (2) exposure assessment on modifiable risk factors; (3) analytical challenges related to small numbers and multiple statistical tests; (4) the role of genetics, including the collection of specimens and analysis of genetic data; and (5) challenges in translating research and demonstrating public health impact. Understanding these issues is important for researchers planning studies, reviewers evaluating the scientific merit of results from these studies, and consumers of the research, including fellow researchers, policy makers, health care providers, and families.

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“…In the post-marketing setting, isolated case reports of adverse pregnancy outcomes are difficult to interpret without a known denominator of exposed women, and post-marketing controlled observational studies are not systematically conducted. Therefore, there are insufficient human pregnancy safety data available for more than 80% of drugs currently available on the US market [4]. …”

Section: Introductionmentioning

confidence: 99%

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et al. 2006

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For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described.

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Teratogenicity of recently introduced medications in human pregnancy

Abstract: We conclude that inadequate information is available for pregnant women and their physicians to determine whether the benefits exceed the teratogenic risks for most drug treatments introduced in the past 20 years.

Cited by 112 publications

References 20 publications

The second wave: Toward responsible inclusion of pregnant women in research

The second wave: Toward responsible inclusion of pregnant women in research

Challenges in Studying Modifiable Risk Factors for Birth Defects

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