Product News and Recalls

FDA Issues Warning and Requires Label Change of Fentanyl Pain Patches

The U.S. Food and Drug Administration (FDA) recently issued a warning about the dangers of accidental exposure to and the improper storage and disposal of fentanyl patches.

Fentanyl is a potent opioid pain reliever and is used to treat patients in constant pain. The patches work by releasing fentanyl into body fats, which slowly releases the drug into the bloodstream over 48 to 72 hours, allowing for long-lasting pain relief. However, because of the potency of the drug, improper storage and disposal can lead to accidental exposure which can cause serious harm among pets, children and adults, and has caused some deaths.

The FDA is aware of 32 accidental exposures to fentanyl since 1997, and 12 deaths, with the majority of them involving children under 2 years old. The FDA is urging patients to follow the instructions on the medicine label and to talk to their health care professional about how to best prevent others from coming in contact with used fentanyl patches.

To reduce the possibility that children will be exposed to fentanyl, the FDA is asking fentanyl patch users to take the following precautions:

  • Keep fentanyl patches and other drugs in a secure location that is out of children’s sight and reach because toddlers may think the patch is a sticker, tattoo, or bandage.
  • Consider covering the fentanyl patch with an adhesive film to make sure the patch doesn’t come off of your body.
  • Throughout the day, make sure—either by touching or looking at it—that the patch is still in place.

Additionally, the FDA announced that it will require color changes to be made to the writing that appears on the fentanyl pain patches and will require the name and strength of such drugs to be written in permanent ink so that the dose and strength of the patch is more clearly visible.

If you or a loved one has suffered injury because of accidental exposure to fentanyl patches, contact Lopez McHugh for a free consultation.