The Food and Drug Administration (FDA) recently issued a warning that the use of certain types of anesthesia and sedatives could have a negative effect on the neurodevelopment of children under the age of three. The FDA found that in animal and human studies when certain types of anesthesia or sedative drugs were used for more than three hours, or if used repeatedly, it could cause a range of developmental and behavioral disorders. Based on the studies, the alert urges physicians to consider the risks and the benefits of using anesthesia in children under three, particularly if the procedure is expected to last longer than three hours.
The FDA will be changing the labeling on 11 of the most commonly used sedative and anesthetic drugs, including propofol, ketamine, phenobarbital, and benzodiazepines, to warn healthcare professionals of the potential risks associated with the drugs. For many physicians, surgeons, and anesthesiologists, this raised concerns over the fact that this new labeling could delay important surgical procedures in younger patients. In addition, some worry that it could also lead to delays in procedures that require short-term sedation, including certain types of imaging studies.
The FDA responded to these concerns by clarifying that there are acceptable exceptions to the rule. If a surgery is medically necessary for a child under the age of three, it should not be avoided. However, healthcare professionals and parents should consider delaying surgical procedures that are elective.
Researchers Find Flaws in the FDA Study
Authors of a New England Journal of Medicine article claim that the FDA warning was based on studies that had methodological flaws. For example, there may have been other factors that caused the developmental delay in patients. They also cited other sources that contradicted cognitive side effects associated with anesthesia. The General Anesthesia vs. Spinal/Regional study and the Pediatric Anesthesia and Neurodevelopmental Assessment study showed that there were no cognitive side effects associated with a single, brief exposure to anesthesia.
From a medical malpractice perspective, the FDA’s alert is a source of concern for two reasons. First, there is the increased malpractice risk for a failure to refer because of the concern over potential adverse developmental outcomes. There is also the risk of developmental and behavioral side effects secondary to the anesthesia that was administered to a young child.
Pediatricians are urged to include a child’s parents, the surgeon, and the anesthesiologists when coming up with a treatment plan. They should discuss the risks and the benefits of a procedure that involves exposure to anesthesia, including any imaging studies that require sedation. If local anesthesia is an option, this may be an acceptable alternative, avoiding some of the potential malpractice risks that are associated with general anesthesia.
Baltimore Medical Malpractice Lawyers at LeViness, Tolzman & Hamilton Advocate for Victims of Medical Negligence
If you or a loved one has suffered from an illness or injury due to the potentially hazardous side effects of anesthesia, you are urged to contact the Baltimore medical malpractice lawyers at LeViness, Tolzman & Hamilton as soon as possible. If your physician did not warn you of the potential side effects of the anesthesia, or there was a problem with the medication, we will work tirelessly to ensure that the appropriate party is held liable. Our dedicated team will seek the maximum financial compensation you deserve. To schedule a free consultation, call us today at 800-547-4LAW (4529) or contact us online.
Our offices are located in Baltimore, Columbia, Glen Burnie, and Towson, allowing us to represent medical malpractice victims in Maryland, including those in Anne Arundel County, Carroll County, Harford County, Howard County, Montgomery County, Maryland’s Western Counties, Southern Maryland, and the Eastern Shore, as well as the communities of Catonsville, Essex, Halethorpe, Middle River, Rosedale, Gwynn Oak, Brooklandville, Dundalk, Pikesville, Nottingham, Windsor Mill, Lutherville, Timonium, Sparrows Point, Ridgewood, and Elkridge.