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Fentanyl Manufacturers Must Use Clearly Visible, Longlasting Ink on Patch Packaging After Two Children Die from Inadvertent Exposure to Drug

Filed September 24th, 2013 Laurie

Manufacturers of fentanyl pain patches must make communications on their product’s packaging more clear and easier to read. The U.S. Food and Drug Administration (FDA) announced the requirement on Monday, after two children died from accidentally exposure to the ultra-strong painkiller patches.

Fentanyl is a narcotic pain medication available in several forms, including a patch that adheres to the skin. Johnson & Johnson (J&J) markets fentanyl under the name Duragesic, and generic forms are also available, reported.

The FDA announced last April that fentanyl patches could be deadly to young children who are accidentally exposed to any that may have fallen on the floor or that were improperly discarded. On Monday, the agency said it will require color changes to the writing on fentanyl patches so they can be seen more easily. Companies are now required to print the name and the strength of the fentanyl on the patch in long-lasting ink, in a clearly visible color, according to

“The current ink color varies by strength and is not always easy to see,” the FDA said in a statement. “This change is intended to enable patients and caregivers to more easily find patches on patients’ bodies and see patches that have fallen off, which children or pets could accidentally touch or ingest.”

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