Published online: February 18, 2020
On June 30, 2015, the U.S. Food and Drug Administration (FDA) replaced the pregnancy letter category system (A, B, C, D or X) with narrative summaries of the risks of using a drug or biological product during pregnancy and lactation. The new labeling format was created to improve how available data was presented, but until now, clinician awareness, use, and perception of this new format was uncertain.
Namazy et al, in an article recently published in The Journal of Allergy and Clinical Immunology: In Practice, used a survey developed in collaboration between the American Academy of Allergy, Asthma & Immunology (AAAAI) and the U.S. FDA, to assess the value of the new labeling format.
Of 184 AAAAI members who completed the email survey, less than half (46%) of respondents were aware that the pregnancy letter category system had been removed and replaced with a summary of available safety data. Most concerning was that the majority (95%) of respondents continued to use the old pregnancy letter category system to make prescribing decisions. These survey results suggest that the pregnancy letter category format is continuing to be used despite significant flaws in the old system. Based on the survey results, the FDA will obtain more detailed input on how busy clinicians prefer to receive pregnancy safety information in labeling.
The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.