NEW: RI Attorney General Appeals to FDA

NEW: RI Attorney General Appeals to FDA

Attorney General Peter F. Kilmartin(D) has written a letter to the U.S. Food and Drug Administration appealing for a black box warning to be placed on opioid analgesics in response to increasing cases of Neonatal Abstinence Syndrome.

Neonatal Abstinence Syndrome, or NAS, is common in newborns whose mothers were using opioids during pregnancy. The loss of opioids at birth can cause a variety of symptoms in newborns including vomiting, failure to gain weight, weight loss, hyperactivity and tremors.

“As the use of prescription opioid analgesics increases, so do the instances of NAS,” wrote Mr. Kilmartin in his 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.”

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Nationally, the instances of NAS have tripled over the past decade. It is estimated that in 2009, 13,539 infants nationwide were born with NAS. That calculates to approximately one infant born every hour in this country with NAS, and those babies have a significantly greater chance of having respiratory issues, low birth weight, feeding difficulties and seizures.

In addition to the human toll, the financial costs associated with NAS are staggering. 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.