AGs call for 'black box warning' on prescription pain relievers

By Jessica M. Karmasek | May 13, 2013

WASHINGTON (Legal Newsline) -- The National Association of Attorneys General sent a letter Monday to the U.S. Food and Drug Administration urging it to require a so-called "black box warning" on prescription pain relievers in an effort to better protect newborns.

Such drugs, the NAAG says, may cause Neonatal Abstinence Syndrome, or NAS.

NAS is caused when infants who have been exposed to opioids during pregnancy suddenly lose their drug supply at birth.

Opioid analgesics relieve pain without causing loss of consciousness. Codeine, hydrocodone and oxycodone fall into this medication class.

Signs of withdrawal in infants can include tremors, vomiting and hyperactivity.

NAS cases are rising nationwide at an alarming rate, the attorneys general argue.

"As the use of prescription opioid analgesics increases, so do the instances of NAS," according to NAAG's letter, addressed to Dr. Margaret Hamburg.

"We therefore believe that a 'black box warning' for these medications would help ensure that women of childbearing age -- as well as their health care providers -- are aware of the serious risks associated with narcotic use during pregnancy."

The letter was signed by 43 state and territorial attorneys general.

To read it, click here.

From Legal Newsline: Reach Jessica Karmasek by email at

More News

The Record Network