Evidence map›Paper›PMID 30137587›Full record

ReviewRheumatology (Oxford, England)2018

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

Bonnie L Bermas, Melissa Tassinari, Megan Clowse, Eliza Chakravarty

Abstract readReview
In one paragraph

Review in Rheumatology (Oxford, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Rheumatologic Medication Use During Pregnancy.Obstetrics and gynecology · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Bonnie L BermasDivision of Rheumatic Diseases, University of Texas Southwestern Medical Center, Dallas, TX.
Melissa TassinariIndependent Consultant, Boston, MA.
Megan ClowseDivision of Rheumatology and Immunology, Duke University Medical Center, Durham, NC.
Eliza ChakravartyDivision of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.

Funding

International Conference on Reproduction, Pregnancy, and Rheumatic DiseaseR13AR070007 · NIAMS · DUKE UNIVERSITY · PI CLOWSE, MEGAN E.B. · 2016 to 2016
$15k
NIAMS NIH HHS R13 AR070007
6 · The paper itself

Abstract

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.

Indexed as

Antirheumatic AgentsDrug LabelingFemaleHumansMaternal ExposurePregnancyPregnancy ComplicationsRheumatic DiseasesRisk AssessmentUnited StatesUnited States Food and Drug AdministrationAntirheumatic Agents

Identifiers

PMID30137587
PMCPMC6099131

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.