FDA to Require Safety Label Changes for Methadone and Buprenorphine Use in Pregnancy

June 9th, 2016

The U.S. The Food and Drug Administration (FDA) is requiring safety label changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder to ensure providers have complete information about the benefits and risks of these products. The intent of this change is to inform prescribers about the risks of neonatal opioid withdrawal syndrome without inadvertently discouraging treatment for pregnant women with opioid addiction.

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