FDA Overhauls Painkiller Patch Labels After Child Deaths

Law360, New York (September 23, 2013, 5:40 PM EDT) -- The U.S. Food and Drug Administration on Monday approved labeling changes for powerful pain-relieving patches made by Janssen Pharmaceuticals Inc., a division of Johnson & Johnson, in response to a dozen instances of children dying after accidental exposure.

The revisions will result in Duragesic patches being stamped with long-lasting ink that more clearly indicates the presence and dosage of narcotic painkiller fentanyl, and makers of generic patches are being asked to the take the same action. Previously, ink color varied by strength and “was not always...
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