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JUNE 28, 2016

FDA Requires Labeling Changes of MAT Drugs for Opioid Disorder in Pregnancy

The FDA is mandating safety labeling changes for all methadone and buprenorphine products in relation to use by pregnant women for the medication-assisted treatment (MAT) of opioid use disorder.

The aim of the changes is “to ensure providers have complete information about the benefits and risks of these products,” according to an FDA statement.

National guidelines from the American Congress of Obstetricians and Gynecologists (ACOG) and the Substance Abuse and Mental Health Services