FDA Label Rule Change Gives Prescribers More Detail for Pregnant Women With Asthma

Treating lung conditions like asthma in pregnant women is a challenge, as it requires knowledge of both the safety of treatments during pregnancy as well as understanding the risks of the disease for both the woman and the infant, noted a review of a new Food and Drug Administration (FDA) information system for prescribers. The review focuses on biologics for uncontrolled or severe asthma in pregnant women and was published recently in the Annals of the American Thoracic Society.

Asthma is the most common pulmonary condition in pregnant women. In pregnant women with uncontrolled or severe asthma, hypoxia and abnormal blood gas abnormalities can cause an increased risk of adverse perinatal outcomes, including prematurity and reduced fetal growth.

Biologics were shown to be effective in patients with severe asthma, but because pregnant women were excluded in these trials, the safety and efficacy of these biologics in this population is unknown. In the pregnancy risk summary information of asthma biologics, data pertaining to pregnant women and lactation was insufficient to inform any drug-associated risk.

However, in one study, patients with severe asthma on omalizumab had similar congenital anomalies, gestational age, and low birth weight infants as the general population. The current scarcity of information in pregnant women for these biologics highlights the need for greater human data collection in this population.

The newly created Pregnancy and Lactation Labeling Rule that the FDA devised helps to redefine pregnancy information on package inserts. This change in pregnancy information and effort from the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), coordinated by the American Academy of Allergy Asthma and Immunology, to collect medication use in pregnant women will enhance the tools clinicians have for pregnant women, the authors wrote.

In the past, the FDA used lettered pregnancy labeling (A, B, C, D, X) to weigh the risk and benefits of each drug in pregnant women. While this information on the package insert was useful, many clinicians believed it to provide inadequate information on gestational management decisions. On June 1, 2015, the FDA revised pregnancy information by creating the Pregnancy and Lactation Labeling Rule. Narrative summaries in accordance with pregnancy labor and delivery, lactation, and reproductive potential replaced these obsolete pregnancy categories.

The VAMPSS gathers information regarding medication use in pregnant women through 4 branches. The first is a case-control study that provides birth defects surveillance for drugs available before November 30, 2015. Although this study is not enrolling new patients and cannot detect the risks of asthma biologics, it can evaluate relationships between birth defects and uncontrolled asthma, as well as other asthma medications before 2015.

Two other branches conduct retrospective cohort studies that gather data from previous Medicaid and commercial databases, such as congenital malformation, and prospective cohorts that manage observational study designs and provide risk counseling to pregnant women and healthcare providers. The final component of VAMPSS is the independent advisory committee, which reviews clinical trials and manuscripts submitted regarding pregnancy and medication use.

The efficacy and safety of many drug classes, such as asthma biologics, is uncertain in pregnant women because of the paucity of pregnant women enrolled in clinical trials. From the new expectations that the FDA has imposed on prescribing information and VAMPSS, there is better chance that additional safety information and management decisions will be available for pregnant patients.

Reference

Schatz M, Krishnan JA, Chambers C. Implications of changes in US Food and Drug Administration prescribing information regarding the safety and use of asthma biologics during pregnancy. Ann Am Thorac Soc. 2018:15(10):1131-1136. doi: 10.1513/AnnalsATS.201806-400PP.