Other safety alerts
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| The United States: FDA Drug Safety Communication: FDA review results in new warnings about using general anaesthetics and sedation drugs in young children and pregnant women |
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The U.S. Food and Drug Administration (FDA) is warning that repeated or lengthy use of general anaesthetic 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.
Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general anaesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behaviour or learning. Further information on the clinical studies can be found in ‘Data Summary’ in the FDA website. However, further research is needed to fully characterize how early life anaesthetic exposure affects children’s brain development.
To better inform the public about this potential risk, FDA is requiring warnings to be added to the labels of general anaesthetic and sedation drugs. List of General Anaesthetic and Sedation Drugs Affected by this Label Change can be found in the FDA website. FDA will continue to monitor the use of these drugs in children and pregnant women and will update the public if additional information becomes available.
Anaesthetic and sedation drugs are necessary for infants, children, and pregnant women who require surgery or other painful and stressful procedures, especially when they face life-threatening conditions requiring surgery that should not be delayed. In addition, untreated pain can be harmful to children and their developing nervous systems.
Health care professionals are advised to balance the benefits of appropriate anaesthesia in young children and pregnant women against the potential risks, especially for procedures that may last longer than 3 hours or if multiple procedures are required in children under 3 years. Discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures requiring anaesthetic and sedation drugs.
Parents and caregivers are advised to discuss with their child’s health care professional the potential adverse effects of anaesthesia on brain development, as well as the appropriate timing of procedures that can be delayed without jeopardizing their child’s health. Pregnant women should have similar conversations with their health care professionals. Also talk with them about any questions or concerns.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm532356.htm
In Hong Kong, there are 30 registered pharmaceutical products containing general anaesthetics and sedation drugs listed in the FDA website, including desflurane (1 product), etomidate (1), isoflurane (5), ketamine (5), midazolam injection (7), pentobarbital (1), propofol (6) and sevoflurane (4). Desflurane, isoflurane and sevoflurane are over-the-counter medicines while the remaining products are prescription only medicines. So far, the Department of Health has not received any adverse drug reaction report related to negative effects on behaviour and learning resulting from use of these drugs in young children and pregnant women. In view of the above FDA announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, December 15, 2016
Issued at HKT 16:00
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