Georgia Department of Law, from the office of Samuel S. Olens, Attorney General


Attorney General Olens Urges the FDA to Place Warnings on Powerful Prescription Drugs to Protect Newborns

May 13, 2013

Attorney General Sam Olens, along with 42 state attorneys general, sent a letter today 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. 

“Women who are pregnant need to be aware that opioids are powerful drugs, which can cause serious harm to their babies,” said Attorney General Olens. “Placing a black box warning on opioids is a simple step that can be taken to alert expectant mothers to the dangers of these drugs.”

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, which means they 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.

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 and Georgia 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.

In Georgia, an analysis of 152 counties by the Georgia Bureau of Investigation Medical Examiner’s Office found that 512 deaths were directly caused by prescription drugs in 2011. This analysis largely excluded Metro Atlanta counties so the number is actually higher.

A major factor fueling prescription drug abuse is the rapid growth of pill mills in Georgia, which often operate under the facade of pain management clinics. In order to combat this alarming public safety problem, Attorney General Olens championed legislation, which passed the General Assembly this year, to regulate pain management clinics. Governor Deal signed The Georgia Pain Management Clinic Act on May 2, 2013, and it will take effect July 1, 2013.

The letter from the Attorneys General is attached.

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