FDA warns of pediatric accidental exposure to fentanyl patch

April 27, 2012

FDA has issued a safety alert, warning patients, caregivers, and healthcare professionals about the dangers of accidental exposure to and improper storage and disposal of fentanyl patches.

FDA has issued a safety alert, warning patients, caregivers, and healthcare professionals about the dangers of accidental exposure to and improper storage and disposal of fentanyl patches.

The fentanyl transdermal patch is marketed under the brand name Duragesic and also is available as a generic product. Fentanyl is an opioid pain reliever used to treat chronic pain by releasing the medication over the course of 3 days. According to FDA, there have been 26 cases of accidental exposure to the patch medication since 1997, with 10 incidents resulting in death and 12 in hospitalization. Sixteen of these 26 cases have involved children younger than 2 years old.

Due to their curiosity, these toddlers are at particular risk of accidental exposure by swallowing the patch or adhering the patch to themselves as a sticker. They may find patches that have been improperly stored, those that have fallen off, or haphazardly placed in easy-to-reach trash areas. FDA also warns that patches that are not secured may detach and transfer to a child when he or she is being held. 

Overdoses of fentanyl can slow breathing and increase levels of carbon dioxide in the blood, resulting in serious side effects, including death.

FDA recommends that healthcare professionals educate patients and caregivers about the appropriate use and disposal of fentanyl patches. This includes folding used or left-over patches in half on the sticky side and securing and then flushing them down the toilet rather than placing them in the trash.

Any cases of accidental exposure should be reported immediately to FDA’s MedWatch Safety Information and Adverse Event Reporting program here.