Attorney General Pam Bondi News Release
September 10, 2013
Media Contact: Jenn Meale
Phone: (850) 245-0150

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Attorney General Bondi Applauds FDA for Granting Request to Add Boxed Warnings to ER/LA Opioid Analgesics about Neonatal Abstinence Syndrome

TALLAHASSEE, Fla.–Attorney General Pam Bondi today released the following statement on the U.S. Food and Drug Administration’s safety labeling changes and post-market study requirements for extended-release and long-acting ER/LA opioid analgesics. In May, Attorney General Bondi and other attorneys general asked the FDA to put warning labels on certain pain-relieving drugs to prevent misuse of those products by expectant mothers. Today’s announcement by the FDA includes the requirement of a new boxed warning on ER/LA opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome.

“In May, we urged the FDA to place a warning on opioid analgesics, and I am so pleased that the changes the FDA announced today include our recommendation. Our support of these changes is a continuation of our overall efforts to protect the most vulnerable victims of this prescription drug abuse epidemic—newborns suffering from Neonatal Abstinence Syndrome.”

To view the letter that Attorney General Bondi and other attorneys general sent to the FDA in May, please click here: http://myfloridalegal.com/webfiles.nsf/WF/MMFD-97NPDY/$file/nas_warning_label_letter.pdf

Attorney General Bondi worked with the Legislature to establish the Statewide Task Force on Prescription Drug Abuse and Newborns. Click here to read more about Attorney General Bondi’s efforts to stop prescription drug abuse.