Fentanyl patches under review following fatalities
The FDA has ordered Janssen, the manufacturer of Duragesic – marketed as Durogesic in Australia – and manufacturers of generic fentanyl patches, to change the writing on their patches to make them more visible.
Fentanyl patches are PBS listed for chronic severe disabling pain not responding to non-narcotic analgesics.
Two Australian cases of suspected accidental exposure of Durogesic in children have been reported to the TGA, one in 2009 which resulted in somnolence and another, in 2010, in which a boy lost consciousness.
The regulator is now considering whether similar packaging changes are required here.
In the US, the name and strength of the narcotic must now be printed in long-lasting ink, in a colour that is clearly visible to patients and caregivers.
“The current ink colour varies by strength and is not always easy to see,” the FDA said.
“This change is intended