-J&J adds warnings to Duragesic pain patch label

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Update 1-J & J adds warnings to Duragesic pain patch label

Fri Jul 8, 2005 7:51 PM ET

NEW YORK, July 8 (Reuters) - & Inc. <JNJ.N> has added

warnings to its Duragesic pain patch label to include information about

possible misuse and abuse, U.S. health regulators said on Friday.

Duragesic's label includes new information on interactions with central

nervous system depressants and alcohol, according to a letter from

J & J's Janssen unit posted on the U.S. Food and Drug Administration Web

site.

The Duragesic skin patch, used to manage persistent moderate to severe

chronic pain, contains a high concentration of fentanyl, an

opium-containing sedative.

So-called opioids, including morphine, have the highest potential for

abuse and associated risk of fatal overdose due to slowdowns in

breathing.

The new labeling will warn that Duragesic, which had sales of $2

billion in 2004, is only for use in patients who are already tolerant

to opioid therapy of comparable strength and that use in non-tolerant

patients may lead to death from respiratory depression.

The warning may be seen in its entirety at

http://www.fda.gov/medwatch/SAFETY/2005/duragesic_ddl.pdf