Duragesic Fentanyl Pain Patches

Representing Victims of Duragesic Fentanyl Patch Overdoses

Duragesic is the trade name of a fentanyl transdermal therapeutic system manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica (both subsidiaries of Johnson & Johnson). Fentanyl got FDA approval in 1990 and is a powerful opioid, which has morphine like action in the body, and is used for moderate to severe pain relief. Since Duragesic releases fentanyl slowly through the skin, one patch may provide 72 hours of pain relief. Individuals should not use a Duragesic skin patch unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Another popular Opioid medicine is Oxycontin.

Back in February 2004, Janssen along with the FDA notified healthcare professionals of a Class I recall of more then 400,000 Duragesic patches with an expiration date of October 2005. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl. As a result increased side effects, consisting of nausea, sedation, drowsiness, or potentially life threatening complications can occur. If the hydrogel contents leak out of the patch, there may not be ample medication to treat the patients' pain. In an opioid tolerant patient, this may lead to withdrawal symptoms, which include sweating, sleeplessness and abdominal discomfort. In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that more than 20% of the recalled patches might still be in use.

In July 2005, the FDA issued a Public Health Advisory concerning the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. Additionally, a patient information sheet and an alert to healthcare professionals were issued identifying several significant safety precautions for the use of fentanyl transdermal patches. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.

In 2007, the Division of Public Health Sciences, Wake Forest University School of Medicine, and the Institute for Safe Medication Practices performed an Adverse Events Reporting System Review of the U.S. FDA's most dangerous drugs. The study discovered fentanyl to be the second most dangerous drug available on the market with the second highest number of suspect drug deaths.  During the study, fentanyl was involved in no fewer than 3,500 suspect drug deaths during the 8-year period.

Free Lawsuit Consultation

If you or a loved one has suffered due to a Duragesic Fentanyl Pain Patch n you may have valuable legal rights. Contact Mark & Associates, P.C. today for a free legal consultation. We represent Duragesic Patch clients on a contigency fee basis. This means there are no up front legal fees, and we are only compensated if we recover money on your behalf.