FDA Follows With Public Health Advisory on Duragesic and Other Fentanyl Patches

On July 8, 2005 Johnson & Johnson Inc. added warnings about possible misuse and abuse to its Duragesic pain patch package insert label.  The Duragesic skin patch is prescribed to manage persistent moderate to severe chronic pain.  Duragesic contains a high concentration of the narcotic fentanyl, an opium-containing sedative.  Generally, opium-containing drugs are called opiods; as a class, these drugs have the highest potential for abuse.

The new labeling for Duragesic will warn that this prescription pain patch product is only for use in those patients who are already tolerant to opioid therapy of comparable strength.  Furthermore, the new warning language alerts doctors that use of Duragesic in non-tolerant patients may lead to death from respiratory depression.

Duragesic’s revised label will also includes new warning information on drug-drug interactions with central nervous system depressants and alcohol.  More details are set forth in a "Dear Doctor" letter from J&J’s Janssen unit which has been posted on the FDA’s web site.

The FDA made this comment in a prepared statement: "The agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product."

On July 15, 2005 the FDA issued a Public Health Advisory on the Fentanyl Patch.  In large part, this FDA public advisory was intended to inform doctors and patients about how to properly use and dispose of these fentanyl pain patches.

In this fentanyl drug-safety alert, the FDA said it had recently conducted a review of adverse-event reports for Duragesic, in particular. The FDA said determining instances of unintentional overdoses was difficult because many patients had underlying diseases such as cancer that could have contributed to their deaths.  Complicating their analysis was evidence of abuse and misuse, as noted above.

As pointed out above, the fentanyl patches are sold under the brand name Duragesic by Janssen, a unit of Johnson & Johnson.  In addition, fentanyl patches have been available as a generic since earlier this year.

More recently, it has been reported that the FDA is investigating 120 reports of deaths possibly linked to overdoses from fentanyl pain patches, including J&J’s Duragesic product.

(Posted by: Tom Lamb)