FDA Mandates Label Changes for Anesthetic Medicines for Pediatric Use

The FDA has brought in place a new decree. It mandates labeling changes on general anesthetic and sedation medicines that are used in children below the age of three years. As per the new ruling, the labeling needs to have:

  • Warning stating that exposure to these medicines for prolong periods of time or over multiple surgeries may have a negative impact on the brain development of children below 3 years
  • Inclusion of information in the labeling section to describe studies in pregnant animals and young animals that exposure to general anesthetic and sedation medicines for over three hours can result in extensive loss of nerve cells in the developing brain
  • Addition of information that exposure to general anesthetic and sedation medicines in young animals can lead to loss of nerve cells that can cause negative effects on the animals’ behavior or learning capabilities in the long run.

Use of General Anesthetic Regulated among Pregnant Women, Young Children in U.S.

As per the FDA, general anesthetic and sedation medicines are given to patients, including pregnant women and young children who undergo surgery or other painful procedures. In the U.S., surgeries in the last trimester of pregnancy that require general anesthesia are carried out only when medically necessary and are expected not to go on for more than three hours.

Pregnant women are advised not to delay or avoid surgeries in these situations, as this can have a negative impact on themselves and the fetus, the FDA added. Similarly, surgeries in children below the age of three years should not be postponed if medically necessary. However, elective surgeries in young children should be delayed where medically appropriate.

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