(RxWiki News) The US Food and Drug Administration (FDA) has approved label changes for anesthesia and sedation medications to be used in young children.
The FDA previously announced these changes, but now they're officially approved. The changes apply to children younger than 3. They include the following:
- Labels on these medications must note that exposure to anesthesia and sedation medications for long periods of time or over multiple surgeries or procedures may have a negative impact on brain development in children younger than 3.
- Labels must include specific information under the pregnancy and pediatric use sections. This information, based on findings from animal studies, must describe the possible negative effects these medications can have on the developing brain when exposure exceeds three hours.
General anesthesia and sedation drugs are given to patients who are undergoing surgery or painful procedures. In the United States, surgeries that require general anesthesia are performed on pregnant women in their third trimester only when medically necessary. These procedures rarely last more than three hours.
The FDA is not recommending that pregnant women delay or avoid surgeries, however. Avoiding or delaying surgeries could harm pregnant women and their unborn babies if the procedure is, in fact, needed. The same goes for children who are younger than 3, according to the agency.
Your health care provider will discuss the risks and benefits of anesthesia and sedation drugs with you, especially for long procedures or for young children who need multiple procedures.
If you have any questions about risks tied to anesthesia or sedation drugs, speak with your health care provider. Also, talk to your health care provider about the timing of procedures. In some cases, procedures may be delayed until after pregnancy or after the child is older.
The FDA recommends that users report side effects associated with these drugs to the FDA MedWatch program.