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Attorney General Gansler Urges FDA to Put Black Box Warning on Opioids
Pregnant mothers and doctors should know about the increase in newborns dependent on painkillers


Baltimore, MD ( May 14, 2013) - Attorney General Douglas F. Gansler, joined by 42 other attorneys general, 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.

"Awareness can help prevent a newborn from facing complications in the early stages of life," said Attorney General Gansler. "The health risks to newborns from these drugs require that we take immediate steps to inform pregnant women and their physicians about this growing problem."

It is estimated that in 2009, there were 13,539 newborns nationwide with NAS. That equates to approximately one infant born with NAS every hour in this country. They face 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, the nationwide 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 it from ever occurring.

"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 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 consecutive year in 2010 with more than 38,300 deaths linked to prescription painkillers.

To read the entire letter from the Attorneys General to the FDA, visit: http://www.oag.state.md.us/Press/FDA_NAS_Warning_Label_Letter.pdf

   

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