New FDA warnings for anesthetic drug use in young children and pregnant women

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New FDA warnings for anesthetic drug use in young children and pregnant women

A new warning from the U.S. Food and Drug Administration (USFDA) that repeated or long-term exposure to general anesthetics and sedatives in children younger than 3 years or women in their third trimester of pregnancy may affect neurodevelopment of children and the fetus.

While research suggests that single, short exposures to anesthetics or sedatives don't have a negative impact on behavior and learning, animal studies and various human studies indicates that exposure to anesthetics or sedatives for longer than 3 hours laeds to neuronal loss. However, further research is needed to determine exactly how this exposure adversely affects the neurological developments in children.

As a result, label warnings will now be required to general anesthetics and sedatives by the FDA to inform the public about its potential risk to children’s neurological development. The FDA is advising health care professionals to observe the potential risks and benefits of exposure in this population, especially for procedures longer than 3 hours or a series of procedures, and to communicate those risks and benefits to patients and caregivers as well.

Instead of these known side effects, anesthetic, and sedation drugs are sometimes need to be used in infants, children, and pregnant women who undergo surgery or other debilitating conditions, which may be life-threatening and may require a surgical operation.

The use of general anesthetic and sedation drugs will continue to be monitored by the FDA for further information about adverse events. The FDA encourages health care professionals to assess the appropriate use of these drugs and balance the benefits against their potential risks, especially for procedures taking longer than 3 hours or in multiple procedures required for children younger than 3 years old. Pregnant women should discuss any questions or concerns with health care professionals, and parents and caregivers should discuss their child’s health and any potential adverse effects as well without jeopardizing their child’s health.

Source:

FDA

Link to the source:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533195.htm

Original title of article:

General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women

FDA
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