FDA: Methadone and Buprenorphine Get Safety Labeling Changes

The U.S. Food and Drug Administration (FDA) announced that methadone and buprenorphine products are getting safety labeling changes.

When these medications are used as medication-assisted treatment (MAT) of opioid use disorder in pregnant women, the fetus is at risk of opioid exposure, which can cause neonatal opioid withdrawal syndrome (NOWS).

The new labeling will reflect this risk in order to provide health care professionals with a full picture of the benefits and risks associated with use of these products.

“Since NOWS can result from in utero exposure to opioids – whether medically authorized or illicit – the risk of NOWS from MAT must be balanced against the risk of untreated opioid addiction during pregnancy; an independent advisory committee and numerous reproductive health experts agree this balance is important,” the FDA noted in a statement. “If left untreated, illicit opioid use is associated with poor pregnancy outcomes such as low birth weight, preterm birth, or fetal death.”

Click here to read the announcement.

--Stephanie Vaccaro

Reference:

1. U.S. Food and Drug Administration. Neonatal opioid withdrawal syndrome and medication-assisted treatment with methadone and buprenorphine. www.fda.gov. Accessed May 26, 2016.