FRANKFORT, Ky. (9/11/13) – Attorney General Conway today applauded the U.S. Food and Drug Administration (FDA) for adding a warning to long-acting or extended release opioid analgesics about the dangers of using these prescriptions during pregnancy.
The FDA made the change after being contacted by Attorney General Conway and 42 of his colleagues. General Conway co-chairs the National Association of Attorneys General Substance Abuse Committee.
"I applaud the FDA for making this change that will better alert physicians and patients about the dangerous consequences of using these powerful prescription painkillers during pregnancy," General Conway said. "The warning labels on long-acting and extended release opioid analgesics are a good first step, and I hope similar labels will one day be included on all opioid prescriptions."
General Conway and his colleagues contacted the FDA after states across the country reported seeing an increase in the number of babies born addicted to prescription drugs. In Kentucky alone, instances of Neonatal Abstinence Syndrome (NAS) have risen 2,500 percent over the past decade – from 29 incidents in 2001 to 730 in 2011. It is estimated that in 2009 there were 13,539 newborns nationwide born with NAS.
Now, as part of new safety measures announced by the FDA, the boxed warning labels will warn expectant mothers that "the use of the products during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS.)" It warns the condition may be life-threatening to the baby and require management according to the protocols developed by neonatology experts. NOWS, also known as NAS, can occur in a newborn exposed to opioid drugs while in the mother's womb. Symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.
"Babies who are born dependent on powerful painkillers can face a lifetime of challenges, both physically and mentally," General Conway said. "These are the youngest victims of an epidemic that is shattering families across Kentucky and the country. I appreciate the FDA joining us in our efforts to educate patients about the dangers of these drugs so we can work to reverse this alarming trend."
In addition to the human toll, the financial cost associated with treating newborns addicted to opioids is staggering. In a 2012 Journal of American Medical Association article, a group of physicians determined that treating a single newborn addicted to opioids in 2009 cost approximately $53,000. That same year, nationwide, the healthcare costs associated with infants born addicted to prescription painkillers was an estimated $720 million, and Medicaid paid for the majority of those treatment costs.
In Kentucky in 2011, the estimated cost of treating newborns born addicted to opioid painkillers totaled nearly $40 million, most of which would be Medicaid costs, or costs hospitals would have to incur without reimbursement.
For more information about preventing prescription drug abuse, please visit http://ag.ky.gov/rxabuse.
Information provided by the office of Attorney General
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