FDA: Label changes for use of general anesthetic, sedation drugs in young children

Editor's Note

The Food and Drug Administration (FDA) on April 27 issued a Safety Alert saying the agency had approved label changes on the use of general anesthetic and sedation drugs in children younger than 3 years.

The changes include:

• A new warning that exposure to these drugs for lengthy periods of time or during multiple surgeries or procedures may negatively affect brain development.
• Additions that include studies in young and pregnant animals showing exposure to these drugs for more than 3 hours can cause loss of nerve cells in the developing brain, and studies in young animals suggesting these changes can result in long-term negative effects on behavior and learning.

Posted 04/27/2017] AUDIENCE: Consumer, Surgery, Anesthesiology ISSUE: FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes include: A new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.