Other safety alerts
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| The United States: General Anaesthetic and Sedation Drugs: Drug Safety Communication - FDA approves label changes for use in young children |
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The U.S. Food and Drug Administration (FDA) has approved previously announced label changes regarding the use of general anaesthetic 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 paediatric use to describe studies in young animals and pregnant animals that showed exposure to general anaesthetic 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.
General anaesthetic and sedation drugs are necessary for patients, including young children and pregnant women, who require surgery or other painful and stressful procedures. In the U.S., surgeries during the third trimester of pregnancy requiring general anaesthesia are performed only when medically necessary and rarely last longer than 3 hours. FDA is advising that in these situations, pregnant women should not delay or avoid surgeries or procedures during pregnancy, as doing so can negatively affect themselves and their infants.
Similarly, surgeries or procedures in children younger than 3 years should not be delayed or avoided when medically necessary. Consideration should be given to delaying potentially elective surgery in young children where medically appropriate.
This is an update to the MedWatch alert "General Anaesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women" issued by the FDA on December 14, 2016.
Health care professionals should continue to follow their usual practices of patient counseling including discussing the benefits and risks of surgeries or procedures that require general anaesthesia and sedation drugs. FDA will continue to monitor the use of these drugs in children and will update the public if additional information becomes available.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm555631.htm
In Hong Kong, there are 49 registered pharmaceutical products containing general anaesthetics and sedation drugs listed in the FDA announcement in December 2016, including desflurane (1 product), etomidate (1), isoflurane (5), ketamine (5), lorazepam (15), midazolam injection (11), pentobarbital (1), propofol (6) and sevoflurane (4). Desflurane, isoflurane and sevoflurane are over-the-counter medicines while the remaining products are prescription only medicines. Related news was previously issued by the FDA and Health Canada, and was posted on the Drug Office website on 15 December and 23 December 2016 respectively. Letters to inform local healthcare professionals were also issued on 15 December 2016. So far, the Department of Health has not received any adverse drug reaction report related to the above adverse effects in young children. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, April 28, 2017
Issued at HKT 16:00
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