Duragesic Patch (Fentanyl) Lawyers
Personal Injury Lawyers - Representing People Nationwide
Duragesic and Durogesic are trade names of fentanyl transdermal therapeutic systems. Fentanyl, which was developed by Janssen Pharmaceutica, is an opioid approximately 80 times as potent as morphine. By slowly releasing it through the skin, one patch of Duragesic can provide up to 72 hours of pain relief. Janssen, which also markets Duragesic, and ALZA Corporation, which manufactures it, are both subsidiaries of Johnson & Johnson.
Duragesics' form-fill-seal system, in which fentanyl-laden gel is sealed between a drug-permeable release liner and an impermeable backing, makes it convenient for those suffering with chronic pain and have trouble swallowing or have allergies to other pain medications. But as early as March 2004, Janssen began a series of recalls of the patch because of a life-threatening manufacturing defect.
On July 15, 2005, the Food and Drug Administration (FDA) followed suit by issuing its own Public Health Advisory as it investigated about 120 fatalities that may have been related to the fentanyl patch. The alert urged that health care professionals educate Duragesic users regarding proper patch application, recognizing the signs of overdose, the concurrent use of other medications, proper storage and disposal, and safeguards for children.
The FDA then issued another advisory on December 21, 2007. This time the concern was that despite the previous advisory, doctors were continuing to inappropriately prescribe the fentanyl patch for indications it was not intended for, including mild or occasional pain, headaches, and acute pain following surgery. Patients were also replacing the patch more frequently than directed, applying more patches than prescribed, and exposing the patches to a heat source, all of which were resulting in dangerous levels of the drug in the blood. Consequently, the FDA was continuing to receive reports of life-threatening side effects and death in patients who used the fentanyl patch.
To prevent the additional problem of illegitimate abuse, Janssen-Cilag designed the Durogesic patch, which contains the fentanyl throughout a plastic matrix rather than in a gel, which is easier to remove or even smoke within the patch. Other manufacturers have also produced patches that contain the drug in a silicone matrix.
But as recently as February 12, 2008, Jenssen announced another recall of all its 25 mcg/hr Duragesic CII patches sold in the US by PriCara and all 25 mcg/hr fentanyl patches sold in the US by Sandoz, Inc. with expiration dates prior to January 2010. This time, it was found that the patches being recalled "may have a cut along one side of the drug reservoir within the patch" that could expose caregivers and patients to the fentanyl gel.
The announcement urges anyone who comes in contact with the gel to thoroughly rinse the exposed skin with large amounts of water (no soap). Affected patches should also be immediately disposed of by flushing them down the toilet without handling them directly.
If you or a loved one has suffered adverse effects, or a loved one has died as a result of using fentanyl patches, you may be entitled to compensation. For a confidential review of your case, contact a qualified pharmaceutical injury attorney.