Kathleen G. Kane - Pennsylvania Office of Attorney General - Protecting Pennsylvanians

May 13, 2013

AG Kane urges FDA to place black box warning on opioids

HARRISBURG - Attorney General Kathleen G. Kane, along with 42 other attorneys general, today sent a letter to the U.S. Food and Drug Administration (FDA) urging the agency to place a black box warning on opioid analgesics to indicate the risk of Neonatal Abstinence Syndrome (NAS).

NAS is caused when infants, who have been exposed to opioids through their mother's pre-natal use, suddenly lose their opioid drug supply at birth. The withdrawal of the opioids can cause a variety of symptoms in the newborns including tremors, vomiting, high-pitch crying, hyperactivity, weight loss, and failure to gain weight.

"As the use of prescription opioid analgesics increases, so do the instances of NAS," wrote the Attorneys General in their letter to the FDA. "We therefore believe that a black-box warning for these medications would help ensure that women of childbearing age, as well as their healthcare providers, are aware of the serious risks associated with narcotic use during pregnancy."

In 2009, it is estimated that there were more than 13,000 newborns nationwide with NAS. That means one infant is born every hour with the syndrome. These babies have a significantly greater chance of having respiratory issues, low birth weight, feeding difficulties, and seizures.

While NAS is a treatable disease, the best course of action is to prevent it from occurring in the first place.

In a 2012 Journal of American Medical Association article, a group of physicians determined that treating a single newborn with NAS in 2009 cost approximately $53,400. That same year, nationwide, the healthcare costs associated with NAS infants was an estimated $720 million, and Medicaid paid for the majority of these treatment costs.

Attorneys General from Kentucky and Florida, who co-chair the National Association of Attorneys General (NAAG) Substance Abuse Committee, led the effort to write the FDA about this important issue. Along with Kentucky and Florida, Pennsylvania joined the following Attorneys General on the letter; Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Georgia, Guam, Hawaii, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virgin Islands, Washington, West Virginia, and Wyoming.

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