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Attorney General Conway and Colleagues Urge FDA to Place Black Box Warning on Opioids

Monday, 05 13, 2013

Shelley Catharine Johnson
Deputy Communications Director
502-696-5659 (office)

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.

Combating prescription drug abuse

In addition to his work on NAAG's Substance Abuse Committee, General Conway launched Kentucky's first and only statewide Prescription Drug Abuse Prevention Task Force in August of 2009. The task force has been involved in more than 430 prescription drug diversion investigations, including Operation Flamingo Road, the state's largest prescription drug bust that resulted in the arrest of more than 500 people.

In 2010, General Conway launched the Keep Kentucky Kids Safe initiative with the Kentucky Justice Cabinet and its Office of Drug Control Policy, Kentucky Pharmacists Association, National Association of Drug Diversion Investigators (NADDI), Operation UNITE and concerned parents. Since its launch, Attorney General Conway and his partners have alerted more than 20,000 students about the dangers of prescription drug abuse.

General Conway also worked closely with Governor Beshear, House Speaker Stumbo, Senate President Stivers and other lawmakers to win passage of landmark legislation in 2012 to prevent the abuse and diversion of prescription pills in the Commonwealth. Since its passage, prescriptions for hydrocodone are down almost 20 percent and prescriptions for Opana have been almost cut in half.

Attorney General Conway's Office has also filed suit against Purdue Pharma, the manufacturers of OxyContin for misrepresenting the addictive nature of the drug. A recent federal appeals court ruling has cleared the way for the case to be heard in Pike Circuit Court.

General Conway's efforts are making a difference. The latest report from the Substance Abuse and Mental Health Services Administration (SAMHSA) shows a decline in the non-medical use of prescription pain relievers among all age groups in Kentucky. The state is also below the national average for prescription drug abuse, for the first time.

In addition to the work being done here in the Commonwealth, Attorney General Conway reached across party lines to work with General Bondi in Florida to ensure that her state implemented an electronic prescription drug monitoring system similar to Kentucky's KASPER system. Together they have worked to shut down the pill pipeline between Florida and Kentucky and to see that all 50 states have prescription drug monitoring programs are in place and that all of the programs can share data across state lines.