Washington, DC—The American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), and The Academy of Breastfeeding Medicine (ABM) released the following statement regarding the U.S. Food and Drug Administration’s (FDA) new guidance on codeine and tramadol in breastfeeding mothers:
“Last week, the FDA issued a Drug Safety Communication against the use of two types of opioid medications—codeine and tramadol—in breastfeeding mothers due to possible harm to their infants. According to the FDA, breastfeeding is not recommended during treatment with codeine or tramadol, due to the potential for serious adverse effects in the infant due to opioid overdose. These adverse reactions occur in a small percentage of individuals who are ‘ultra-rapid metabolizers,’ whose bodies break down medicines much faster than usual, causing dangerously high levels of active drug in their bodies.
“While these reports and concerns underscore the need for preemptive guidance regarding opiate effects in all patients, ACOG, SMFM and ABM continue to urge all obstetric providers to ensure that application of this guidance does not interfere with pain control or disrupt breastfeeding. Clinicians caring for women must ensure adequate pain control and simultaneously avoid doses of opioid medications that may be toxic to mothers and/or to their breastfed infants.
“Safe management of pain in non-pregnant women who are breastfeeding begins with maximizing the use of non-opioid pain medication.
“If opioid medication is required, ACOG, SMFM and ABM recommend that clinicians adopt one of the following strategies to enable adequate pain control and continued breastfeeding:
- Consider prescribing an opioid medication other than codeine or tramadol
- If codeine-containing medication is the preferred choice, the risks and benefits of this drug should be discussed, along with the reasoning behind the FDA guidance
“Regardless of the medication selected, it is prudent to counsel mothers prescribed any opioid medication about the potential risks to both mother and breastfed infant and to limit the duration of opiate prescription if clinically appropriate.”
For more information, please visit ACOG's resource page on breastfeeding.
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 58,000 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
The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership organization representing the interests of obstetricians/gynecologists who have additional formal education in maternal-fetal medicine. The Society is devoted to reducing high-risk pregnancy complications by providing continuing education to its more than 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine. SMFM hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed. For more information, visit www.smfm.org
The Academy of Breastfeeding Medicine is a worldwide organization of physicians dedicated to the promotion, protection, and support of breastfeeding and human lactation. www.bfmed.org