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

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.

Anti-IFNαR Mabs for the treatment of systemic lupus erythematosus

“…This reflects unplanned pregnancies and pregnancies in those women for whom the benefits of using the biologic to control disease activity, particularly in the first and/or second trimester, is deemed to outweigh theoretical risks. New FDA rules in place since 2015 mean that applications for drug approvals must provide pregnancy and lactation information for the label, including the details of any existing pregnancy registry [59]. A pregnancy registry would be a most useful contribution to the post-approval process for anifrolumab given the lack of pre-existing human or animal data for medications of this class.…”