Name: Duragesic Patch
Generic: Fentanyl Transdermal System
Manufacturer: Alza Corp. – a division of Johnson & Johnson
Date approved: November 1, 2000
Status: Prescription only
Approved uses: Long term relief of moderate to severe pain
Off-Label uses: Migraine headaches, pain from surgery or an injury, severe but short-term pain
• Trouble breathing
• physical dependence
• drop in blood pressure
• dry mouth
• and sweating
Related topics: Fentora
Duragesic Patch (Fentanyl Transdermal System)
The Duragesic patch is a transdermal delivery system for the opioid pain reliever fentanyl. Since the Duragesic patch releases fentanyl slowly through the skin, one patch may provide 72 hours of pain relief. The Duragesic system employs a form-fill-seal technology in which a fentanyl-laden gel is sealed between an impermeable backing and a drug-permeable release liner. The patches are available in formulations that release 12, 25, 50, 75 and 100 micrograms per hour.
Duragesic patches are manufactured by Alza Corp. (a division of Johnson & Johnson) and have received many safety warnings and have also been voluntarily recalled a number of times, including a March 2004 Duragesic recall of some batches of the 75 microgram patch. The U.S. Food and Drug Administration (FDA) issued a safety warning in December 2007 over the patches, saying improper use could cause breathing difficulties and death. That followed a July 2005 FDA alert put out after 120 patients taking the drug died. Johnson & Johnson stated in November 2007 that it faced 72 lawsuits over the patches. Most recently, in February 2008, Johnson & Johnson voluntarily recalled all 25-microgram-per-hour patches that are sold in the U.S. by the company’s PriCara unit and Sandoz. Johnson & Johnson stated they instituted the recall because manufacturing defects in the 25 microgram patches may cause leaks that can lead to fatal overdoses. It estimated that in all, about 32 million patches will be recalled.