Morrisey Joins 42 Other Attorneys General in Letter to FDA Seeking ‘Black Box’ Warning About Prescription Opioid Use During Pregnancy
CHARLESTON – Attorney General Patrick Morrisey today announced that West Virginia has joined 42 other states and territories in a letter to the U.S. Food and Drug Administration (FDA) seeking “black box” warnings on all opioid-based pain killers to alert pregnant women that using the medicine during pregnancy could cause Neonatal Abstinence Syndrome (NAS).
NAS is a group of problems a newborn experiences when exposed to addictive illegal and prescription drugs in the womb. It can include problems with an infant’s autonomic nervous system, respiratory system and gastrointestinal tract. Signs of NAS include abnormal sleep pattern, tremors, vomiting, high-pitched crying, irritability, hyperactivity, seizures, weight loss and failure to gain weight.
Boxed warnings on a prescription drug’s label are designed to call attention to serious or life-threatening risks. The letter from the attorneys general requests that the FDA add the warning to let women of childbearing age, as well as their doctors and pharmacists, know about the serious risks associated with the narcotic’s use during pregnancy.
“Women who are pregnant need to understand the risks associated with taking prescription pain medicine to their unborn children,” Attorney General Morrisey stated. “The addition of a black box warning will help get the message out that the medication they are taking could have a serious impact on the health of their baby.”
The problem of drug-addicted infants is not new, but statistics indicate it is becoming more common. Earlier this year, a report issued at the seventh annual Drug Prevention Summit in Huntington showed that 75 out of every 1,000 babies born at Cabell Huntington Hospital have been exposed to drugs or alcohol. The national average is five per 1,000. (1)
The letter from the attorneys general says the human and financial costs of NAS are alarming. It cites a 2012 Journal of American Medical Association article that showed treating a newborn with NAS cost approximately $53,400 per infant in 2009. The article estimated the cost of treating newborns with NAS exceeded $720 million nationwide.
With prescription drug abuse a growing problem in every corner of the state, Morrisey said it is imperative for the FDA to include the additional warning on labels for prescription pain pills.
“The drug abuse problem is crippling so many West Virginia families and communities,” he said. “But it will be virtually impossible to remedy this plague if babies from their very first breath are fighting off addiction. We need to take every step we can to fight this battle.”
To read a copy of the letter to the FDA, click here
(1) http://www.herald-dispatch.com/x1925881302/Drug-addicted-babies-staggering-problem; http://www.wvha.org/Media/News-Center/NewsScan/2013/April/4-12-Drug-addicted-babies-staggering-issue.aspx