We received a new FDA communication dated August 3, 2022 about benzodiazepine use during pregnancy:
This communication is to inform you that FDA is requiring manufacturers of all benzodiazepine medicines to update and standardize the prescribing information to reflect several possible risks that may affect newborns exposed to benzodiazepines during pregnancy or while breastfeeding.
An FDA review of available data determined that all benzodiazepines carry risks of withdrawal syndrome in newborns and excessive sleepiness or sedation can negatively affect newborns’ breathing. We reviewed postmarketing databases and the published literature on pregnancy risks associated with benzodiazepine use from January 1, 1968, through January 20, 2022. Our review found reports of withdrawal symptoms in newborns exposed to all benzodiazepine medicines late in pregnancy. We also found reports of newborns with low muscle tone, sedation, and respiratory symptoms exposed to benzodiazepines late in pregnancy or during labor. As a result, we are requiring the risks be included in information across this entire class of medicines.
We are also requiring updates to the existing patient Medication Guides to help alert patients and caregivers about these risks. FDA will continue to monitor benzodiazepine medicines as part of our routine pharmacovigilance of all FDA-approved drugs and will follow up by communicating to the public, if necessary, should additional information become available.
