FDA Warns on Anesthetic, Sedative Use in Pregnant Moms and Children

FDA Warns on Anesthetic, Sedative Use in Pregnant Moms and Children

Use of general anesthetics or sedation drugs should be avoid in women who are late in their pregnancy and children less than the age of 3 since use can lead to learning deficits and could harm developing brains in unborn babies and young children.

The Drug Safety Communication issued Dec. 14 by the FDA noted the new warnings indicating this risk must be added to the label of general anesthetic and sedating medications.

“We recognize that in many cases these exposures [to these meds] may be medically necessary and these new data regarding the potential harms must be carefully weighed against the risk of not performing a specific medical procedure,” Director of the FDA’s Center for Drug Research and Evaluation, Janet Woodcock, MD, said in a statement.

The FDA has been investigating this issue since at least 2013 when the agency announced it was working with the International Anesthesia Research Society to determine if anesthesia causes long-term learning deficits in children.


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


Did you find this article helpful?


Latest News

Breaking News – EpiPen Malfunction

Breaking News – EpiPen Malfunction

Just released from the FDA – Pfizer has informed the FDA that they are aware of several continuing problems that people are having using the EpiPen (epinephrine) and EpiPen Jr (epinephrine) auto-injectors and generic versions. Some of the problems are from user error and some from EpiPen malfunction. Here are…

ACE Inhibitors in the Time of Coronavirus

ACE Inhibitors in the Time of Coronavirus

Are you worried about ACE inhibitors and coronavirus? You may be hearing that one of the entry methods for the coronavirus in humans is by attaching to the ACE-2 enzyme. This has raised alarms among those with heart disease who use ACE inhibitors (with names ending in -pril, such as…

  • Advertisement