Washington, DC – Hal C. Lawrence, MD, Executive Vice President and CEO of the American College of Obstetricians and Gynecologists (ACOG), released the following statement regarding the Food and Drug Administration (FDA) labeling change for methadone and buprenorphine used in medication-assisted treatment (MAT) for opioid use disorder:
“The American College of Obstetricians and Gynecologists thanks the FDA for recognizing that health care providers need balanced information regarding both the risks and the benefits of MAT for opioid use disorders during pregnancy. ACOG and its Fellows have long recognized the growing, tragic reality of opioid use disorders in the United States and appreciates that the FDA is taking steps to ensure that women living with opioid use disorders during pregnancy are able to receive the evidence-based care they need.
“Withdrawal from opioid use during pregnancy is associated with poor neonatal outcomes, including early preterm birth or fetal demise, and with higher relapse rates among women; robust evidence has demonstrated that maintenance therapy during pregnancy can improve outcomes.
“Of course, opioid use during pregnancy – including MAT, prescription opioid use for pain, or non-medical opioid use – can put infants at risk of neonatal abstinence syndrome (NAS). However, NAS is both expected and treatable, and evidence has shown that it does not lead to long-term complications. Because of superior outcomes associated with MAT compared with withdrawal, ACOG continues to recommend use of MAT as the standard of care during pregnancy for women with opioid use disorders.
“Moreover, it is important for health care providers to understand that use of opioids during pregnancy can be indicated. Opioids should only be used for treatment of pain when alternatives are not appropriate or effective, but we also know that there are times, including during pregnancy and the postpartum period, when such use is both appropriate and safer than the alternative. Opioids may be needed to treat chronic or acute pain such as pain from cesarean delivery, kidney stones, sickle cell crisis or trauma in pregnancy, or as part of an established plan to treat problems associated with substance use disorders.
“ACOG understands that the issue of opioid use during pregnancy is complex, but we strongly advocate for an evidence-based approach to opioid use during pregnancy that supports the ability of pregnant women to access appropriate care. We thank the FDA for helping to take another important step in this direction.”
Additional resources can be found at acog.org/opioids and below:
Resources for Providers
Opioid Use, Dependency, and Addiction in Pregnancy (Committee Opinion No. 524, May 2012, Reaffirmed 2014)
Alcohol Abuse and Other Substance Use Disorders: Ethical Issues in Obstetric and Gynecologic Practice (Committee Opinion No. 633, June 2015)
Guidelines for Perinatal Care, 7th Edition (2012, page 127-130)
Resources for Women and Families
Tobacco, Alcohol, Drugs, and Pregnancy (FAQ 170, December 2013)
Pregnancy: Methadone and Buprenorphine (ASAM Pamphlet)
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