Health Canada reviewing potential negative effects of general anesthetics and sedatives on young children and fetuses

Starting date:

December 22, 2016

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-61598

• Issue
• Media enquiries
• Public enquiries

Issue

OTTAWA – Health Canada is reviewing the safety of certain drugs used for general anesthesia and sedation in children under the age of three, or in pregnant women during their third trimester. This follows a recent communication by the U.S. Food and Drug Administration (FDA) warning the public that repeated or lengthy use of general anesthetics and sedatives in these groups may have potential negative effects on the development of children’s brains.

“General” anesthetics and sedatives are administered by highly trained specialists in healthcare settings so that the patient is unconscious and does not feel pain during surgery, procedures or tests. General anesthetics are usually given by injection into a vein, or inhaled. The risk being communicated does not involve “local” or “regional” anesthetics, which are used to numb specific areas or regions of the body.

As noted in the FDA communication, studies in young animals have shown that anesthetics can be harmful to the developing brain. Some studies of children who have undergone anesthesia suggest that there may be long-term effects on learning and behaviour, while other studies have not shown a link. It is difficult to know whether these effects were due to the drugs or other reasons, such as the medical condition for which the anesthesia was needed. According to the FDA, recent human studies suggest that a single, relatively short exposure to general anesthetics and sedatives in infants or toddlers is unlikely to have negative effects on behaviour or learning.

Health Canada is currently reviewing this safety issue and collaborating with other foreign agencies. We are assessing all available information, including scientific literature and new international developments, to determine whether the current labelling accurately reflects the scientific knowledge that has been obtained from animal studies.

The department will continue to update Canadians, including health professionals, as the review is completed, and will take action, as needed, to optimize the benefits and reduce the risks associated with anesthetics and sedatives in children and pregnant women.

Anesthetics and sedatives are essential to preventing pain during surgery and other procedures or tests. They play a vital role in critical and sometimes life-saving procedures that should not be delayed. When making any decisions on the necessity and timing of a procedure, health professionals and patients should weigh the risks and benefits. Pregnant women, parents and caregivers should discuss any questions or concerns about the use of sedatives, general anesthesia and/or the necessity of a procedure with their healthcare professional.

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