On December 14, 2016, the FDA issued a drug safety communication regarding the use of general anesthesia and sedatives for pregnant women and for young children, informing health care providers, parents, and caregivers of children younger than three years, and pregnant women in their third trimester, that the repeated or lengthy (more than three hours) use of general anesthetic and sedation drugs may adversely affect children’s developing brains.
The FDA will require that warnings be added to the labels for such drugs, recognizing that in many cases these exposures may be medically necessary and the new data regarding the potential harms must be carefully weighed against the risk of not performing a specific medical procedure.
The FDA’s Drug Safety Announcement warns that recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning; however, further research is needed to fully characterize how early life anesthetic exposure affects children’s brain development.
The FDA notes that published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain, and studies in young animals suggest these changes result in long-term effects on the animals’ behavior or learning.
Some studies in children support the findings from previous animal studies, particularly after repeated or prolonged exposure to these drugs early in life. The FDA notes that the studies in children had limitations and that it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.
The FDA states that health care professionals should balance the benefits of appropriate anesthesia 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, and that health care professionals should discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures requiring anesthetic and sedation drugs.
The FDA’s Drug Safety Announcement concludes with, “We urge health care professionals, patients, parents, and caregivers to report side effects involving anesthetic and sedation drugs or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.”
It is not always clear if a patient suffered injury as a result of anesthesia, or as a result of the actions or inactions of an anesthesiologist, when a surgical patient experiences an unexpected adverse event during or following surgery.
If you or a loved one were injured by anesthesia in the United States, you should promptly find a local medical malpractice lawyer in your state who may investigate your medical malpractice claim for you and represent you in a medical malpractice case, if appropriate.
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