ACOG Statement on the FDA Warning Regarding Use of General Anesthetics and Sedation Drugs in Pregnant Women
December 22, 2016
Washington, DC – Thomas Gellhaus, MD, president of The American College of Obstetricians and Gynecologists (ACOG), released the following statement on the U.S. Food and Drug Administration’s (FDA) Dec. 14 drug safety announcement, “FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women”:
“ACOG has significant concerns regarding the FDA’s warning that repeated or lengthy use of general anesthetic or sedation drugs during surgeries or procedures in pregnant women during their third trimester could result in negative developmental effects in children. ACOG believes the clinical significance of these findings are unknown and could inappropriately dissuade clinicians from providing women with necessary care during pregnancy.
“According to published studies cited by the FDA, more than three hours of exposure resulted in widespread loss of nerve cells in the developing brain. However, the findings that pertain to growing fetuses were based on studies in pregnant animals—not pregnant women. Furthermore, in the animal studies, exposure that resulted in loss of nerve cells involved time periods of five to 24 hours, depending on the drug used, not the three hours of exposure described in the announcement. Due to these substantial data limitations, ACOG maintains that women in any trimester of pregnancy should be counseled regarding evidence-based benefits and risks of any proposed interventions which may involve the use of general anesthetic or sedative agents. No women should be denied a medically indicated surgery or procedure which may involve the use of these agents.
“The FDA also announced that it will now require warnings to be added to the labels of general anesthetic and sedation drugs. It is extremely unlikely that a pregnant woman or fetus would be exposed to these drugs for the time period described as potentially harmful for either an obstetric or non-obstetric surgery. In the event of prolonged anesthetic exposure due to a complicated delivery, the fetus would be delivered long before the potentially harmful range would be reached. Therefore, FDA-required warnings on labels could cause patients and providers to reject the use of these medically indicated drugs despite the low threshold of fetal exposure.
“ACOG is a science-driven, medical organization that represents and provides clinical guidance to more than 95 percent of the U.S. ob-gyn workforce. Yet, ACOG was not sought after for input with regard to these recommendations. Going forward, it is critical for the FDA to involve ACOG and other obstetric care providers in the development of all safety announcements that affect obstetric care.
“Ob-gyns and other obstetric providers should continue to follow ACOG’s clinical guidance as outlined in Committee Opinion #474, Nonobstetric Surgery During Pregnancy.”
Access Practice Advisory: FDA Warnings Regarding Use of General Anesthetics and Sedation Drugs in Young Children and Pregnant Women.
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The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of more than 57,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization. www.acog.org