J&J must change color of labeling on Duragesic patches to aid safety, FDA says

SILVER SPRING, Md. — The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

The agency announced that it would require J&J subsidiary Janssen Pharmaceuticals to change the color of the ink on Duragesic (fentanyl) patches. The patches administer the drug fentanyl through the skin, but because of the delivery method, they can cause serious harm or even death to children or pets if they touch a patch that has fallen off the patient. The more prominent coloring will make it easier for patients or caregivers to see if the patches have been improperly applied or fallen off.

The FDA also recently issued an advisory saying that fentanyl patches should be discarded by folding the sticky sides together and then flushing them down the toilet, and that patients regularly check them to make sure they haven't come loose.