Children’s Deaths Lead to Changes Required on Labels of Fentanyl Pain Patches

After a number of child deaths attributed to accidental exposure to fentanyl pain medication patches, the makers of the patches have been required to change the printing on the patches to make them more visible.

In April, the U.S. Food and Drug Administration (FDA) warned that fentanyl patches can cause life-threatening harm to children accidentally exposed to patches that have fallen off someone or that have been improperly discarded, Reuters reports. A Consumer Update on the FDA website says that its Division of Medication Error Prevention and Analysis is aware of 32 cases of accidental exposure to fentanyl since 1997, most of them involving children younger than 2 years old. There have been 12 deaths and 12 cases requiring hospitalization.  

Fentanyl, a narcotic, is available in a variety of forms, including a patch that adheres to the skin. Fentanyl is sold under the brand Duragesic by Johnson & Johnson and in generic versions by a number of drug makers. The FDA is requiring color changes to the printing on fentanyl patches so the patches can be seen more easily. Companies must print the name and strength of the drug in long-lasting ink, in a color that is clearly visible to patients and caregivers, according to Reuters.

The FDA statement warns that a child could receive an accidental overdose of fentanyl either by putting a patch in his or her mouth or by applying it to the skin, and this could cause death by slowing breathing and increasing the levels of carbon dioxide in the blood. Infants and toddlers have unique risks for accidental exposure to fentanyl, the FDA explains. Adults often hold infants, and a partially detached patch could be transferred from adult to child. Curious toddlers not yet old enough to understand the dangers are more likely to ingest or stick on a lost, discarded, or improperly stored patch.

The FDA recommends disposing of used fentanyl patches by flushing them down the toilet. Patches should never be placed in household trash, the agency says, where children or pets could find them.