According to several studies, repeated anesthesia use has be associated with developmental disorders such as attention deficit and hyperactivity disorder. Another animal study has shown that anesthesia usage in fetal or young animals has been connected with neural cell deterioration. However, these studies do not show a direct cause-and-effect as to why anesthesia may lead to brain cell malformation and the FDA notes that more research is needed on the topic.
According to the FDA announcement, children under three and pregnant women after their third trimester are most at risk for adverse effects from anesthesia. On the other hand, the FDA recognizes that anesthesia is a common necessity in the medical field that does not exclude children. It is recommended to both parents and healthcare providers to discuss and weigh the potential risks of anesthesia with other medical risks. One-time exposures to anesthesia under three hours is considered a relatively safe procedure regarding the data provided by the FDA.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, stated “We recognize that in many cases these exposures may be medically necessary and these new data regarding the potential harms must be carefully weighed against the risk of not performing a specific medical procedure.”
The research so far conducted by the FDA has not definitively shown “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.”
Drugs That Require New Labeling
The FDA is requiring several drugs to include new labeling to inform consumers of potential risks. The exact language to be used was not specified, but the affected drugs are:
- Suprane (desflurane)
- Amidate (etomidate)
- Forane (isoflorane)
- Ketalar (ketamine)
- Ativan (lorazepam)
- Brevital (methohexital)
- Nembutal (pentobarbital)
- Diprivan (propofol)
- Ultane (sevoflurane)