Wednesday, 05 July 2017 14:47

FDA Approves Label Changes For General Anesthetic And Sedation Drugs Use In Young Children

The National Agency for Food and Drug Administration and Control has been notified by the U.S. Food and Drug Administration (U.S. FDA) of its approval of label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years.

These general anesthetic and sedation drugs are necessary for surgery or other painful and stressful procedures in patients including infants, children and pregnant women. They are administered intravenously or by inhalation to render a patient reversibly unconscious and unresponsive in order to allow surgeons operate on the patient.

The label changes include the following warnings;

  • 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.
  • Exposure to the use of these medicines on pregnant and pediatric patients for more than 3 hours can cause widespread loss of nerve cells in the developing brain. Studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.

Healthcare Provider Action

  • Continue to ensure patients counseling and discussion on the benefits and risks of surgeries or procedures that require general anesthesia and sedation drugs.
  • Parents, caregivers and pregnant women should be encouraged to ask questions on their concerns about these medicines.
  • Healthcare providers as well as patients are encouraged to report adverse events or side effects related to the of these medicines to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

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