Fentanyl Patches Ordered Relabeled After Child Deaths

They look like fun bandages or stickers – eye candy for little children. That’s why parents are being warned about how toxic fentanyl pain patches have been linked to accidental exposures resulting in several child fatalities.

The U.S. Food and Drug Administration (FDA) will require manufacturers of the fentanyl pain patches to make warnings more distinct. Color changes will be required in long-lasting ink with the name and strength of the narcotic so it can be seen more easily. Both the name brand and generic manufacturers will be required to make the changes.

The problem with the current patches is they may be discarded in a trash can where small children or pets can access them with fatal results. Without the loud warnings, no one may be the wiser until it is too late.

Fentanyl (Actiq, Sublimaze and Duragesic) is often prescribed for cancer patients and people in severe pain who cannot tolerate morphine. Even after they are discarded, the fentanyl pain patch contains about half of the dose of the narcotic.

The Institute for Safe Medication Practices reports on the most recent cases of child fatalities:

• A 15-month-old boy was sleeping on his mother’s chest. She had been wearing a fentanyl patch to treat pain associated with multiple sclerosis. Upon awaking she found the boy unresponsive. The baby had apparently ingested the patch. It was missing from his mother’s chest. He died of acute fentanyl intoxication.
• A one-year-old girl swallowed a fentanyl patch she found lying on the ground. Her parents found her dead two hours after she had been tucked into bed.
• A two-year-old boy ingested a pain patch that stuck to the wheels of his toy truck. The patch had been discarded on the ground at his grandmother’s care facility.
• A four-year-old found a discarded fentanyl pain patch and used it like a Band-Aid.

The ISMP blames “bystander apathy” for these tragic incidents reinforcing the role that everyone must play in order to keep children safe.

Death from an overdose of fentanyl can occur when the patch is either put on the skin or taken in the mouth. Breathing slows down as the levels of carbon dioxide increase in the blood. An early symptom could be extreme fatigue or lethargy. Any exposure requires a trip to seek emergency medical help.

Fentanyl also comes in the form of a lollipop.

Adults wearing a patch need to take care that even holding a young child makes it likely there could be some transfer of drug to the youngster. The FDA recommends wearing an adhesive film over the patch to minimize exposure to others.

There have been 32 accidental exposures since 1997, mostly involving children under the age of 2. That includes 12 deaths and 12 hospitalizations.

The FDA recommends after use the patient should fold the patch with the sticky sides together and flush it down the toilet immediately. The agency hopes the change in labeling on the actual patch will make removal and disposal safer.