The FDA has approved label changes for the use of general anesthesia and sedation drugs in young children, given warnings issued in late 2016 about the potential adverse effects on brain development with lengthy or repeated use.
The label changes are as follows:
- A new warning states that exposure for prolonged periods or during multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.
Information has been added to describe studies in young animals and pregnant animals that showed exposure to general anesthetic and sedation drugs for more than 3 hours can cause nerve cell loss in the developing brain, with additional research in young animals suggesting that such nerve cell loss can cause long-term negative effects on behavior or learning.
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