November 13, 2014
ASA, with the Society for Pediatric Anesthesia, Sends Formal Letter to FDA on Potential Toxicity of Anesthetics and Sedation Drugs in the Pediatric Population
On November 12, 2014, the American Society of Anesthesiologists (ASA) and the Society for Pediatric Anesthesia (SPA) sent a formal letter to the U.S. Food and Drug Administration (FDA) Science Board in response to their upcoming November 19 meeting on the use and potential toxicity of anesthetics and sedation drugs in the pediatric population. According to the FDA, “The Science Board will review the existing nonclinical and clinical data related to the use and potential toxicity of anesthetics and sedation drugs in the pediatric population…and make recommendations on steps the FDA should take to further evaluate and to mitigate the risks associated with the use of these drugs in the pediatric population and mechanisms to best communicate with the public regarding this issue.”
In the letter, the societies summarize existing research on the use of anesthetics and sedation drugs in the pediatric population, offer key points about current evidence, and identify major knowledge gaps.
- Accumulated knowledge in rodents and non-human primates leaves little doubt that there is an association between exposure to anesthetic agents and apoptotic neuronal injury in the developing animal brain. What is less clear is whether the observed effects in animals can also be demonstrated in children.
- While virtually all of the existing work in children consists of retrospective cohort studies that are deeply flawed, they show disturbing patterns that constitute evidence of an association. Current research is clearly insufficient to implicate anesthetic exposure as causal with regard to the adverse cognitive outcomes observed in children.
- There are only three ongoing studies with designs that are sufficiently robust to add significantly to the understanding of this issue. None of the three studies will likely report results within the next two years studies and are unlikely to provide the clarity required to reassure both providers and parents.
In addition to the formal comment letter, ASA will offer oral comments to the Science Board recommending urgent action on this issue and will continue to work closely with the FDA and stakeholders to ensure that anesthetic care provided to children is as safe as possible.