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Attorney General Kilmartin Urges FDA to Place Black Box Warning on Opioids

Citing an increase in newborns dependent on painkillers, Attorney General Peter F. Kilmartin, along with 42 of his colleagues, 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-pitched crying, hyperactivity, weight loss and failure to gain weight.

"It is crucial that expectant mothers be aware of the risks associated with medications they are taking, especially opioids," said Attorney General Kilmartin. "When we think of babies born with Neonatal Abstinence Syndrome, it is easy to believe the mothers are chronic drug abusers. But often, that is not the case – many of these drugs were prescribed to the mother prior to pregnancy and taken legally for legitimate health reasons, such as pain killers or anti-depressants. However, these drugs are also highly addictive and many women do not fully understand the side effects some prescription drugs can have on unborn babies."

Nationally, the instances of NAS have tripled over the past decade, and it is 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, 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, and Medicaid paid for the majority of these treatment costs.

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.

Prescription drug abuse a national epidemic

Prescription drug abuse is the fastest growing drug problem in the United States and is classified as an epidemic by the Centers for Disease Control and Prevention (CDC).

Prescription drug abuse is also the leading cause of accidental death in the U.S. and now accounts for more deaths nationally than traffic accidents. According to the National Center for Health Statistics, fatal drug overdoses rose for the eleventh straight year in 2010 with more than 38,300 deaths linked to prescription painkillers.

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