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Duragesic Patches to Change Colour to Prevent Accidents

24-Sep-2013

The US FDA says it requires a colour change of the painkiller patch Duragesic in order to reduce injury and death caused by accidental exposure.

Duragesic is marketed by Janssen and manufactured by Alza Corporation - both subsidiaries of Johnson & Johnson - and is the brand name of fentanyl, an opioid delivered through a transdermal patch.

However, in a safety alert the US Food and Drug Administration (FDA) has called on the manufacturer “to print the name and strength of the drug on the patch in long-lasting ink, in a color that is clearly visible to patients and caregivers,” in order to reduce the risk of accidental exposure to patches that are either used or have fallen off.

Such exposure can lead to death in children and, according to the FDA it has continued to learn of accidental deaths associated with Duragesic which is around 80 times more powerful than morphine .

It won’t just be Alza affected by this requirement as the FDA has also called on makers of generics to comply. One such company is Mylan Technologies who earlier this month completed its transdermal patch plant in St. Albans, Vermont where fentanyl patches are manufactured.

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