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 newbornsā 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.
I am benzo injured. I never had informed consent about tolerance, how addictive or getting off was so dangerous. My psych dr only offered more medicine to shore up what I was going through. Big pharma has no care about long term effects as this is a brain injury and as well to your central nervous system. Drug moguls as well as drs have to account with recourse in our seeking liability to hundred of thousands of us suffering trying to get our lives back.