Duragesic and Fentanyl: FDA Resources & the Black Box Warning

In July 2005 the FDA issued a safety advisory emphasizing the safe use of the fentanyl pain patch also known by the brand name Duragesic and other generic pain patches. Despite this advisory, a large number serious adverse reactions and deaths continue to happen.

On December 21, 2007 the FDA issued another fentanyl safety advisory.

The fentanyl patch contains fentanyl, a very potent narcotic pain medicine which is only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant. It is extremely important that patients be opioid tolerant because of the dangerous side effects of the fentanyl patch.

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For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is enough to cause dangerous side effects, such as severe respiratory distress or very slow or shallow breathing and death.

Adverse reactions and death reports indicate that patients are continuing to incorrectly use the fentanyl patch by replacing the patch more frequently than directed in the fentanyl patch instructions, applying more patches than prescribed, or applying a heat source to the patch, all resulting in dangerously high fentanyl levels into the bloodstream.

Reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should never be prescribed.

FDA Black Box Warning for Duragesic/Fentanyl
DURAGESIC® contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (DURAGESIC®) may be a particular target for abuse and diversion.

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Read the Duragesic fentanyl Black Box warning in its entirety.

For more FDA information, visit our resources page.

Contact a Duragesic patch lawyer about a possible duragesic/fentanyl patch lawsuit.