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Duragesic is an adhesive "pain patch" that is applied to the skin. It delivers a steady dose of fentanyl (a powerful opiate pain medication), over an extended period of time, to persons suffering from chronic and/or debilitating pain.

Johnson & Johnson and Novartis have announced a recall after discovering manufacturing defects that may cause the pain patches to leak the painkiller fentanyl, which could lead to fatal overdoses.

An overdose of fentanyl can cause fatal respiratory and/or cardiac arrest.

The recall affects all Duragesic patches with an expiry date on or before December 2009. The defective patches may have a cut in the patch, allowing direct contact of the fentanyl gel to the users skin.

This is the 5th recall of the Duragesic patch in the last 14 years. The last recall, in July 2005, was issued following the death of 120 patch users.

Due to the dangerous nature of the drug, Duragesic contains a black-box warning label explaining the risk of accidental fatal overdose and respiratory depression or hypoventilation.

Symptoms and Side Effects of Duragesic Fentanyl Patch

Medical professionals are concerned that patients using the Duragesic pain patch are susceptible to accidental overdose which can be fatal. Overdose can occur when the patch is damaged, cut, or defective (as those involved in the recent recall).

Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency. The opioid drug stays in the system for up to 72 hours.

Janssen also warns of other withdrawal side effects and potential damage to the cardiovascular system (bradycardia) and the central nervous system. Long term side effects of Fentanyl are not known.

Duragesic Fentanyl Overdose Articles

Duragesic: Potentially Lethal in the Wrong Hands
The recent recall of Duragesic pain patches should not come as a surprise, given the checkered history of a product that introduces extremely potent pain medication directly through the skin. First approved in 1990, Duragesic has endured several recalls in the last 14 years.

Duragesic Pain Patches: Serious Side Effects
Duragesic patches are meant to alleviate pain in patients who have moderate to severe chronic pain. They are used to give a continuous dose of medication to patients who are not responding to other pain relievers. However, some patients are experiencing extreme reactions to Duragesic patches, including addiction. Furthermore, some of the patches have a manufacturing defect that could be fatal to patients and caregivers.

Legal Issues Imminent for Makers of Duragesic/Fentanyl Patches
Second Duragesic/Fentanyl Recall in Less Than One Week
Duragesic Recall Expanded
Duragesic: This Painkiller Patch Can Kill

Duragesic Fentanyl Overdose in the News

MAR-3-08: Actavis, a maker of fentanyl patches, has expanded a recall to include all of its fentanyl pain patches sold in the United States. [MEDPAGE: DURAGESIC]

FEB-18-08: Patches containing the prescription painkiller fentanyl were recalled for the second time in a week. [MSNBC: FENTANYL PATCHES]

FEB-15-08: Health Canada has announced the recall of two brands of fentanyl pain-relief patches. [CTV NEWS: PAIN PATCHES]

FEB-14-08: Johnson & Johnson's Ortho-McNeil-Janssen unit is recalling all lots of its 25 microgram per hour strength patch of Duragesic, in coordination with the U.S. FDA. [REUTERS: DURAGESIC PATCH RECALL]

FEB-13-08: J&J issues new recall for Duragesic pain patch that could leak and cause fatalities. [RTT NEWS: DURAGESIC PATCH RECALL]

JUL-07-06: Verdict awards plaintiffs $772,500 for death related to Duragesic pain patch. [HEALTH SCOUT: DURAGESIC]

JUL-15-05: The FDA is investigating 120 deaths of users of pain patches that deliver doses of Fentanyl. [WASHINGTON POST]

JUL-15-05: A health advisory has been issued by the FDA regarding the Duragesic fentanyl skin patches after reports of deaths in patients using the painkiller. [FOX NEWS]

Register your Duragesic Fentanyl Patch Case

If you or a loved one has suffered from an overdose while using Duragesic, or if a loved one has died while using Duragesic, you may qualify for damages or remedies that may be awarded in a Duragesic class action or lawsuit. Please click the link below to submit your complaint to a lawyer for a free case evaluation.