FDA Issues Warning for Anesthetic Drugs
The US Food and Drug Administration (FDA) will require new warnings be added to certain anesthetic and sedation drugs after recent studies have found a link between use of these drugs and potential harm of young children’s brains.
Anesthetic drugs are needed for infants, children, and pregnant women who require surgery or other painful procedures, especially when they face life-threatening conditions when treatment cannot be delayed.
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However, the FDA reports that published studies have shown that use of general anesthetic and sedation drugs for more than 3 hours may be associated with severe damage or widespread loss of nerve cells in the brain. These effects can have long-term effects on patients and are most prevalent in those who have had repeated or prolonged exposure to the drugs early in life. However, it was unclear in each of the studies whether any negative effects seen in children’s learning or behavior were due to the drugs or other factors, such as the underlying medical condition that led to the need for surgery or procedure.
Along with the added warnings, the FDA is recommending that health care professionals balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially when procedures are expected to last longer than three hours or if multiple procedures will be necessary. They should also discuss these factors and others with parents, caregivers, and pregnant women.
Patients and caregivers should also discuss the potential adverse effects of anesthesia on brain development, as well as the appropriate timing of procedures that can be delayed without jeopardizing their child’s health.
The FDA has been reviewing the potential adverse effects of general anesthetic and sedation drugs on children’s brain development since the first animal study on the topic was published in 1999. However, they note that more research is still needed on the subject to ensure these drugs are being used safely.
In the meantime, they urge health care professionals, patients, parents, and caregivers to report side effects involving these therapies or other medications to the appropriate organizations.
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FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. FDA Website. https://www.fda.gov/Drugs/DrugSafety/ucm532356.htm. Published December 14, 2016. Accessed December 19, 2016.
