FDA Statement from Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, on new safety information on anesthesia use in young children and pregnant women

FDA Statement

• For Immediate Release: December 14, 2016

Please note: The updated product labels for general anesthetic and sedation medications, which reflect a change in the populations included in the warning, have been approved by the FDA as of April 27, 2017. This is an update from what was communicated on Dec. 14, 2016. Please see the Drug Safety Communication update for more details.

The health of our nation’s children is a responsibility that the FDA takes very seriously. Parents and caregivers are often concerned when their young child requires a medical procedure for which anesthesia or sedation drugs are necessary. Understandably, there are many questions, including whether the drugs are safe for their child. Pregnant women who must undergo medical procedures that require anesthesia or sedation drugs have similar concerns.

Today, based on the FDA’s comprehensive analysis of the latest published scientific studies, we are issuing a Drug Safety Communication to inform 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. To better inform the public of the risks, we are requiring warnings to be added to the labels of these drugs. 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.

In 2010, the FDA formed a partnership with the International Anesthesia Research Society (IARS) called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) to fund additional research to better understand the safe use of these drugs in young children and pregnant women. I would like to thank them and the stakeholders and medical experts in anesthesiology, pediatrics, neuroscience and epidemiology who are working to make surgery safer for the millions of infants and young children who undergo anesthesia or sedation each year. We hope that this information helps enable the most informed medical decisions possible about the use of anesthesia in young children and pregnant women. We will continue to work collaboratively to leverage our collective resources to address this important issue, and we will update the public with additional information, as it becomes available.