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Pharmacoethics and Pregnancy: Overcoming the drug orphan stigma
  • Jamil Kazma,
  • Johannes van den Anker (NO FURTHER ASSIGNMENTS),
  • Homa Ahmadzia
Jamil Kazma
The George Washington University

Corresponding Author:[email protected]

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Johannes van den Anker (NO FURTHER ASSIGNMENTS)
Children’s National Medical Center
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Homa Ahmadzia
The George Washington University
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Abstract

There is paucity of evidence to support clinical decision making and counseling related to medication use in pregnancy. Despite multiple efforts from legislative bodies and advocacy groups, the inclusion of pregnant women in clinical drug trials assessing efficacy and safety remains scarce. Pregnancy can be complicated by multiple co-morbidities that require pharmacological intervention; these interventions primarily target the pregnant women but also sometimes have secondary effects for the fetus. The U.S. Food and Drug Administration has issued multiple guidance documents on incorporating pregnant women in clinical trials to aid pharmaceutical companies in designing a protocol to ensure safety and adherence to ethical standards. Advances in pediatric pharmacology studies provide lessons for researchers on the best practice of designing clinical trials with inclusion of patients from special populations. In this review, we present the status of pregnant women in clinical trials, highlighting the ethical stigma and possible future directives.
11 Aug 2021Submitted to British Journal of Clinical Pharmacology
14 Aug 2021Submission Checks Completed
14 Aug 2021Assigned to Editor
11 Sep 2021Reviewer(s) Assigned
28 Sep 2021Review(s) Completed, Editorial Evaluation Pending
07 Oct 2021Editorial Decision: Revise Major
07 Nov 20211st Revision Received
08 Nov 2021Submission Checks Completed
08 Nov 2021Assigned to Editor
08 Nov 2021Review(s) Completed, Editorial Evaluation Pending
09 Nov 2021Reviewer(s) Assigned
24 Nov 2021Editorial Decision: Accept