(RxWiki News) The US Food and Drug Administration (FDA) has issued a safety announcement concerning the use of general anesthesia and sedation drugs.
This announcement is for the use of these agents in pregnant women during their third trimester and in children younger than 3. The FDA is warning that these agents may affect children's brain development.
General anesthesia and sedation drugs are given to those undergoing surgery or painful procedures.
Past animal studies have suggested that the use of these agents for more than three hours may lead to long-term effects on the animals’ behavior or learning. However, other studies have suggested that a one-time, short use of these agents in infants and young children is not likely to affect behavior or learning.
The FDA, however, calls for more research, particularly in pregnant women and young children. Furthermore, additional research is needed to determine at what point babies' brains are affected when exposed to these agents, the agency said.
The FDA is requiring this warning to be included on the labels of these agents. The agency will continue to evaluate the use of these agents during pregnancy and in young children.
Your health care provider will discuss the risks and benefits of anesthesia and sedation drugs, especially for long procedures or for young children who need multiple procedures.
If you have any questions about the risks tied to anesthesia or sedation drugs, speak with your health care provider. In addition, speak with your health care provider about the timing of procedures. In some cases, the procedure may be delayed until after pregnancy or after the child is older.
The FDA recommends that users report side effects associated with these agents to the FDA MedWatch program.