FDA Adopts Black Box Warning on Opioid Analgesics


FDA Adopts Black Box Warning on Opioid Analgesics

The U.S. Food and Drug Administration (FDA) recently announced it has addressed issues raised in letter from the National Association of Attorneys General which encouraged the agency to affix a “black box warning” to opioid analgesics warning of the risks of narcotic use during pregnancy.

In a letter sent this spring, Attorney General Tim Fox and 42 other attorneys general expressed their concern for newborn babies affected by Neonatal Abstinence Syndrome (NAS), which is caused by maternal opiate use.  NAS happens when infants suddenly lose their opioid drug supply at birth.

“The opioid epidemic has taken the lives of many Americans and has affected many people, including newborn children,” said Attorney General Tim Fox.  “Neonatal Abstinence Syndrome (“NAS”) caused by maternal opiate use has increased at alarming levels.  As the use of prescription opioid analgesics increases, so do the instances of NAS.  We therefore believe that a “black box warning” for these medications would help ensure that women of childbearing age – as well as their health care providers – are aware of the serious risks associated with narcotic use during pregnancy.”

Prescription drug abuse is on the rise across the country, and prescription pain relievers are among the most commonly abused drugs.  A study published last year in the Journal of the American Medical Association, found that approximately one infant with NAS was born every hour in the United States.

Attorneys general from the following states and territories signed onto the letter:  Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virgin Islands, Washington, West Virginia, and Wyoming.

The Attorneys General letter is available here.

The FDA’s news release is available here here.

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