Psychiatric Medications and Reproductive Safety: Scientific and Clinical Perspectives Pertaining to the US FDA Pregnancy and Lactation Labeling Rule

Abstract

Pregnancy labeling of prescription medications in the US is in the midst of a major transformation. The FDA's previous system, which used letter ratings to convey drug safety, was simple but led to misunderstandings-both faulty assurances and undue concerns. The new system, established under the Pregnancy and Lactation Labeling Rule, aims for more descriptive and up-to-date explanations of risk as well as context needed for informed decision-making based on available data. In April 2017, a conference titled "Pharmacovigilance, Reproductive Safety, and the Pregnancy and Lactation Labeling Rule" brought together clinicians and researchers, FDA officials, and representatives of the public and industry to discuss a host of questions relating to the new system. This Academic Highlights article summarizes their discussions, which included topics such as how the new system came about and how the new labeling can be used effectively to inform physician-patient conversations about use of medications during pregnancy and ultimately the clinical decisions that follow.​​.