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FDA Urges Patients and Health Care Providers to Help Prevent Children's Accidental Exposure to Fentanyl Patches
FDA has issued a safety alert reminding patients, caregivers, and health care providers to appropriately store, use, and dispose of fentanyl patches to prevent children’s accidental exposure to the medication, which is potentially life-threatening. FDA recently evaluated a series of 26 cases of pediatric accidental exposures to fentanyl patches reported over the past 15 years, and determined that 10 of the cases resulted in death, and 12 in hospitalization. In addition, 16 of the 26 cases occurred in children two years old or younger.
FDA warns that young children may be at risk for accidental exposure when fentanyl patches are discarded in trash receptacles, or when children find lost or improperly stored patches. Young children can be harmed when they place the patches in their mouths or stick the patches to their skin. In addition, young children are at risk of exposure when being held by someone wearing a partially detached patch that can then transfer to the child. Exposure of young children to a fentanyl patch can lead to serious adverse events and even death, due to the amount of fentanyl present in the patches. FDA stresses that harm can even occur with used patches because they may still contain a considerable amount of fentanyl.
To prevent accidental exposure, FDA advises that patients securely store needed fentanyl patches out of children’s reach and sight. When applying a patch, FDA also recommends that patients consider covering the fentanyl patch with an adhesive film to make sure the patch does not come off. Finally, FDA recommends checking throughout the day to make sure that the patch is still in place.
Further, FDA advises that used or unneeded patches are properly disposed of. FDA recommends that the adhesive side of the patch should be folded together and then the patch should be flushed down the toilet. FDA notes that the agency “recognizes that there are environmental concerns about flushing medicines down the toilet. However, FDA believes that the risk associated with accidental exposure to this strong narcotic medicine outweighs any potential risk associated with disposal by flushing. When the patches are no longer needed, disposing by flushing completely eliminates the risk of harm to people in the home.”
FDA urges health care providers to educate patients and their caregivers about the appropriate use and disposal of fentanyl patches. FDA’s consumer Web page provides detailed information for patients and caregivers. Providers, patients, and caregivers are also encouraged to review the fentanyl patch product label for instructions.
Additional information about safe medication use and storage, and the importance of proper disposal of unneeded medications, is available on the AWARXE® Web site.
