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# FDA Orders Methadone Labeling Changes
- URL: https://www.fdaweb.com/fda-orders-methadone-labeling-changes/
- Published: 2016-05-26T12:00:00.000Z
- Updated: 2026-09-14T21:05:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135778

FDA says it is requiring safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder. The changes are intended to ensure that doctors have complete information on the products’ benefits and risks.

An agency [notice](http://www.fda.gov/Drugs/DrugSafety/ucm503630.htm?ref=fdaweb.com) says that while the American College of Obstetricians and Gynecologists and the Substance Abuse and Mental Health Services Administration recommend that pregnant women with opioid addiction be treated with methadone or buprenorphine, that treatment can present challenges due to the risk of the developing fetus being exposed to opioids.

Since neonatal opioid withdrawal syndrome (NOWS) can result from *in utero* exposure to opioids, whether medically authorized or illicit, the risk of NOWS arising from MAT must be balanced against the risk of untreated opioid addiction during pregnancy, the notice says. “FDA’s action requiring safety labeling changes for MAT-only methadone and buprenorphine products is intended to appropriately inform prescribers about the risks of NOWS without inadvertently discouraging treatment for pregnant women with opioid addiction,” the agency says.

Although labels for buprenorphine products used to treat pain carry a Boxed Warning about the risks associated with NOWS, the changes to the MAT-only products include a statement in the Warnings and Precautions section and related modifications to the Pregnancy, Dependence, and Patient Counseling information sections. A Boxed Warning will not be required.