FDA Issues New Opioid Policy to Combat Birth Defects


New warning labels for opioids are intended to help doctors and patients prevent Neonatal Abstinence Syndrome, thanks in part to Senator Schumer.

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September 11, 2013 – The FDA announced yesterday a class-wide shift in policy on the labeling of opioid medications. Though the exact language of the new warnings which all extended-release and long-acting opioids will be required to carry has not been finalized, officials hope the new labels will alleviate a number of health issues have which resulted from the misuse of these drugs.

“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” said FDA Commissioner Margaret A. Hamburg, MD.

Medicinal opioids are typically used to treat chronic or extreme pain, but can have serious consequences if misused. In addition to being addictive and potentially harmful to those who take them, opioids have also been seen to cause severe complications in fetal development when taken by pregnant women.

Neonatal Abstinence Syndrome (NAS) or Neonatal Opioid Withdrawal Syndrome (NOWS), which occurs when a newborn has been exposed to opioids while in the womb. Prolonged symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying, and in-utero exposure to these drugs has also been linked to decrease birth weight and head circumference. Long-term behavioral and cognitive problems, including impairment of a child’s ability to learn, can also be exhibited by children suffering from NAS.

According to a study published by the Journal of the American Medical Association in May, roughly 3.4 out of every 1,000 infants born in the US in 2009 suffered from NAS, meaning that approximately one child born every hour is afflicted. That birthrate of children with NAS is now nearly triple that of a decade ago. In additional to the terrible toll paid by families, the study also revealed the public cost of treating the syndrome rose form $190 million in 2000 to $720 million in 2009.

In placing new warnings on the packaging of opioids, the FDA hopes to help reduce the incidence of children born with NAS by better educating both patients and doctors about the risks of opioid use while maintaining access to medication for those who truly need it.

“The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use. Today’s safety labeling changes reflect the FDA’s current understanding of the risks and benefits of these products,” said Douglas Throckmorton, MD, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.

The “action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain,” added Dr. Hamburg.

Alterations in the labeling of opioids come after Senator Chuck Schumer began urging the FDA to make changes in October of 2012. Upon hearing of the new policy, he said “The FDA’s new labeling requirements will clearly and prominently warn women of the dangers of chronic opiate use during pregnancy—it will be a crucial treatment in the battle against infant opiate addiction and withdrawal syndromes, and I’m pleased that the FDA heeded my call.”

New postmarket study requirements for all extended-release and long-acting opioid analgesics intended to treat pain will also be implemented alongside the new labels. Drug companies which produce opioids will be mandated to conduct further studies and clinical trials.

[Source: FDA, Senator Schumer]