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FDA Requires New Warning Label for Opioid Drugs After Request From Tim Fox and 42 Other Attorney’s General

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Photo courtesy of Divine Harvester/Flickr

The U.S. Food and Drug Administration has responded to a request by Montana Attorney General Tim Fox and 42 other attorney’s general to create new labeling rules for opioid drugs.

“The opioid epidemic has taken the lives of many Americans and has affected many people, including newborn children,” Fox said. “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.”

When used on many other prescription drugs, black box warning labels have been shown to lead to a decrease in use. In a 2012 study, the Journal of the American Medical Association estimated in that every hour, a child in the U.S. is born with Neonatal Abstinence Syndrome. The syndrome can cause vomiting, slow weight gain, seizures, and a host of other side effects.

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