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Opioids and Birth Defects

The Dangers of Long-Acting Opioid Analgesics

September 10, 2013: The U.S. FDA has announced label changes to long-acting opioid analgesics in an attempt to reduce the risk of overdose injury and/or death in patients. A new black box warning will also warn about the elevated risk of Neonatal Opioid Withdrawal Syndrome when opiates are taken by pregnant or nursing mothers.

“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 in a FDA Press Announcement.

OPIATE USE IN PREGNANCY LINKED TO NOWS

Opioid use in pregnant women has been linked to a life-threatening condition called Neonatal Opioid Withdrawal Syndrome (NOWS). NOWS is characterized by low birth weight and head circumference and can lead to life-long developmental issues.

According to the FDA, “NOWS can occur in a newborn exposed to opioid drugs while in the mother’s womb. Symptoms may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.”

BIRTH DEFECTS LINKED TO OPIOID USE DURING PREGNANCY

Information below from National Center on Birth Defects and Developmental Disabilities, WebMD Health News, and Medscape.

  • Neonatal Opioid Withdrawal Syndrome (NOWS)
  • Decreased birth weight
  • Decreased head circumference
  • Long-term behavioral and cognitive issues
  • Heart Defects
  • Hypoplastic left heart syndrome
  • Spina bifida
  • Glaucoma
  • Hydrocephaly
EXAMPLES OF LONG-LASTING OPIOID ANALGESICS
  • Morphine
  • Oramorph®
  • MS Contin®
  • Avinza®
  • Oxycodone
  • OxyContin®

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