Attorneys General Want Black Box Pregnancy Warning on Painkillers

Powerful opioid painkillers like OxyContin and Vicodin should have strong warnings for pregnant women, say attorneys general from nearly every state.  

In a letter (PDF) sent to the FDA this week by 43 attorneys general, the agency is being urged to place a “black box” warning on opioid painkillers, warning that they can cause infants to suffer addiction and withdrawal from birth.

Black box warnings are the strongest label that the agency can require on a drug. The request was announced in a press release issued on May 14 by Maryland Attorney General Douglas F. Gansler.

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Opioid analgesics are powerful painkillers that work on the opioid receptors in the nervous system and gastrointestinal tract. Some are natural, based off of opium derived from poppies, and others are synthetic. They include drugs like OxyContin, Vicodin, Dilaudid, morphine, and fentanyl, among many others. They are the oldest known class of painkillers in the world.

According to the letter, when a pregnant woman takes an opioid, it puts her unborn child at risk of Neonatal Abstinence Syndrome (NAS) at birth. When the infant is born and no longer connected to the mother, it stops receiving the painkillers that the mother’s body shared with the infant in the womb. The child then begins to suffer drug withdrawal and can suffer symptoms including:

  • Vomiting
  • High-pitch crying
  • Hyperactivity
  • Weight loss
  • Failure to gain weight

The attorneys general estimate that there were 13,539 children born in 2009 with NAS, or about one infant born per hour, at a cost of $720 million to the healthcare system that year. Most of that was paid by Medicare and thus paid for by taxpayers.

“As the use of prescription opioid analgesics increases, so do the instances of NAS,” the attorneys general wrote. “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.”


Last year, the U.S. Centers for Disease Control and Prevention (CDC) declared that unintentional prescription drug overdose deaths had hit “epidemic” levels in the U.S.

Misuse and accidental overdoses of painkillers like OxyContin and morphine have driven the skyrocketing numbers, with opioid painkillers responsible for more deaths than cocaine and heroin combined since 2003.

In 2007, there were about 27,000 unintentional prescription drug overdose deaths in the United States, the CDC reported. Since 2008, prescription drug overdoses have accounted for more deaths than traffic accidents.


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