Today, the FDA issued a drug safety communication that it 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.
- Addition of information to the sections of the labels about pregnancy and pediatric use 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 widespread loss of nerve cells in the developing brain; and studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.
This is an update to the MedWatch alert “General Anesthetic and Sedation Drugs: Drug Safety Communication – New Warnings for Young Children and Pregnant Women” issued on December 14, 2016 in which the FDA warned that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
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