FRANKFORT, Ky. (5/14/13) – Attorney General Jack Conway, along with 42 of his colleagues, today sent a letter to the 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. Link to Letter http://goo.gl/KvO5C.
In Kentucky alone, the instances of NAS have risen 2500 percent over the past decade from 29 incidents in 2001 to 730 in 2011. It's estimated that in 2009 there were 13,539 newborns nationwide with NAS. That calculates to approximately one infant born every hour in this country with NAS, which means they have a significantly greater chance of having respiratory issues, low birth weight, feeding difficulties and seizures.
"Babies who are born dependent on powerful painkillers can face a lifetime of challenges, both physically and mentally," said General Conway, who co-chairs the National Association of Attorneys General (NAAG) Substance Abuse Committee with Florida Attorney General Pam Bondi. "These are the youngest victims of an epidemic that is shattering families across Kentucky and the nation. We must do everything in our power to educate patients and practitioners about NAS so that we can stop this alarming trend."
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, and Medicaid paid for the majority of these treatment costs.
In Kentucky in 2011, the estimated cost of treating newborns with NAS totaled nearly $40 million, most of which would be Medicaid costs, or costs hospitals would have to incur without reimbursement.
In Florida, another state on the frontlines in the fight against prescription drug abuse, there has been a three-fold increase since 2007 in the number of drug exposed newborns.
"We must do everything we can to protect babies from the devastating effects of prescription drug abuse by expectant mothers," said General Bondi. "We recently launched an educational campaign in Florida, and I strongly believe that warnings placed directly on opioid labels is another necessary step in protecting the most vulnerable victims of this epidemic."
While NAS is a treatable disease, the best course of action is to prevent the disease from occurring in the first place.
"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 April, the FDA heeded the bipartisan advice of state Attorneys General and blocked generic drug manufacturers from producing a crushable form of OxyContin, a drug that has fueled addiction and overdoses across the country.
Information provided by the office of Attorney General
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