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FDA Requires New Labels for Fentanyl Patches

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Jarod Cassidy4 years ago

With two more children dead after being accidentally exposed to fentanyl pain relief patches, the U.S. Food and Drug Administration (FDA) is requiring a change in labels for the drug.

FDA Warns About Fentanyl and Child Fatalities

  • Fentanyl, sold as Duragesics by Johnson & Johnson, is a powerful, extended relief opioid pain reliever that comes in a patch form.
  • According to the FDA, these overdoses were caused by children putting improperly disposed of patches either in their mouths or on their bodies.
  • This results in slowed breathing and increased carbon dioxide levels in the blood which may lead to death.
  • MPR reports that 32 incidents of accidental exposure have been reported, most occurring in children under 2 years old.
  • Between 1997 and 2012, the FDA reported 10 deaths and 12 incidents of hospitalization as the result of children being accidentally exposed to fentanyl.
  • As a result, the FDA issued a warning to patients about the potential risk fentanyl poses to children.

FDA Requires New Labels for Fentanyl

“This change is intended to enable patients and caregivers to more easily find patches on patients’ bodies and see patches that have fallen off, which children or pets could accidentally touch or ingest.” – U.S. Food and Drug Administration as published by Fox News

  • Since the FDA warning, there has been tw more reports of children dying due to accident exposure to fentanyl patches.
  • According to Fox News, the FDA is now requiring that the drugs' labels be changed in order for the warning label to be more clearly visible and to make the patches easier to find should they fall where children could reach them.
  • The FDA has stated that the ink used in Duragesic and generic brand labels varies in color and strength. The hope is to create a more standardized, easy to see label to prevent child deaths.
  • Consumers are still urged to dispose of used fentanyl patches by folding them in half and flushing them down the toilet. The patches should never be thrown into a trash can.
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