n January 23, a letter was sent to the editor of The New Yorker magazine on behalf of the ASA Committee on Pediatric Anesthesia and the Society for Pediatric Anesthesia (SPA). The letter, signed by committee Chair Randall M. Clark, M.D., SPA President Francis X. McGowan, Jr., M.D., Mark A. Singleton, M.D., from the California Society of Anesthesiologists, and myself was written in response to a January 10, 2005, article by Jerome Groopman, M.D. The article, titled the “Pediatric Gap,” was a welcome and, for the most part, accurate portrayal of the failure of the Food and Drug Administration (FDA) to require adequate testing of drugs for use in children.

The article opens with a description of a child who apparently responded adversely to the use of bupivacaine to infiltrate a simple laceration prior to repair. The reaction required an intensive care unit admission and was attributed to a “level of bupivacaine in the boy’s blood [that] was perilously high.” Unfortunately the author’s description implies that because of a lack of accurate dosing information provided by the FDA, the use of bupivacaine may be inappropriate in children.

Subsequently Dr. Groopman describes the problem of acidosis associated with the use of propofol among children sedated in pediatric intensive care units. Most in the anesthesiology community are acutely aware of this issue. The author appears to extend the prohibition against the use of propofol for intensive care unit sedation to a suggestion that the FDA has contraindicated the use of propofol among “youths.”

Although it is not entirely clear what Dr. Groopman intended by these statements, the ASA Committee on Pediatric Anesthesia and SPA are concerned that the message received by parents is likely to be that the proper use of these important medications is inappropriate or even dangerous to their children.

The letter, reprinted below, was submitted to The New Yorker on January 23. At the time of this writing, it is not clear whether it will published.

To the editor:

Jerome Groopman, in his extensively researched and thoughtful examination of what he termed “The Pediatric Gap,” has highlighted an issue that resonates with all who have devoted their careers to the care of children. We applaud his journalistic efforts calling attention to the failure of the FDA to require approval of drugs for children, a problem that at the very least complicates the medical care of children and at worst threatens their health and safety. As anesthesiologists specializing in the care of children, we would like to take the opportunity to clarify two critical points made by the author. These points concern the use of medications prominently mentioned by Dr. Groopman.

It is apparent that bupivacaine, a local anesthetic, was responsible for the unfortunate events that occurred during the care of the child described. Bupivacaine, like many medications used in children, is not FDA-approved for pediatric use. However, bupivacaine has been used safely and effectively to relieve pain in both children and adults for several decades. The toxic effects experienced by the child described are well known to physicians familiar with bupivacaine. As with all medications, regardless of whether they are FDA-approved or not, bupivacaine must be used in a dose appropriate to both the size of the patient and the route of administration.

We would also like to clarify the author’s statements with regard to the drug propofol. Propofol is a medication commonly used by anesthesiologists to provide sedation or to induce general anesthesia. Like bupivacaine it is not FDA-approved for use in all children. Propofol, when used continuously, has been reported to cause an accumulation of acid in the blood in some patients. Acidosis associated with the use of propofol is a potentially serious problem that prompted many anesthesiologists to stop using the drug for long-term sedation well before the FDA or the manufacturers’ warning. It is important for readers of The New Yorker to recognize, however, that propofol remains a very useful medication and is not, as the author suggests, contraindicated in care of children.

As pediatric anesthesiologists, we are committed each and every day to providing children with the safest care possible. We appreciate the opportunity to add our voice to that of the author in emphasizing the need for the inclusion of children in the FDA drug approval process. By doing so, we must not unduly alarm parents or create concern about the use of medications that are known to be safe when used appropriately.

Randall P. Flick, M.D., is Head of the Section of Pediatric Anesthesiology, Mayo Clinic, Rochester, Minnesota.