For many years, Duragesic was the only fentanyl patch. However, the patent for Duragesic expired in 2005, opening the door for generic brands. The first such generic brand to be sold in the United States was the Mylan Fentanyl Transdermal System. The Mylan patch is different from the Duragesic patch in that it utilizes a matrix design as opposed to a reservoir design.
Fentanyl Pain Patch Recall Update 7/23/12: Healthcare giant Johnson & Johnson (J&J) is now recalling more than 53,000 Duragesic pain patches due to problems where crystals of fentanyl may have formed in some of the patches. Fentanyl is a potent painkiller approximately 100 times more powerful than morphine, and its accumulation into crystals in the patch has the potential to lead to overdoses and other adverse events.
What’s the problem?
The Mylan form of the fentanyl patch has had a brief and tumultuous history. On Feb. 2, 2005, after a lengthy battle, the FDA approved the first generic version of the Duragesic patch to treat people with severe chronic pain, and was sold by the company under the name Fentanyl Transdermal System.
In July of 2005, the FDA issued a Public Health Advisory. This warning stated that “deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product.” The generic version of Duragesic is called Sandoz. In December of 2007, as part of this continuing investigation, the FDA issued a second Public Health Advisory which stated, “The FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after people incorrectly used it.”
The reservoir design has a front and back and is sealed along the edges to create a “reservoir” where a gel containing fentanyl is placed. This design also utilizes a membrane which limits the amount of fentanyl that enters the skin. The matrix design of the Mylan patch does not have a reservoir or a rate control membrane. The matrix design utilizes only one sheet of film which has an adhesive attached to it, causing the patch to stick to the body. The fentanyl is contained within the adhesive.
Although a Mylan matrix patch cannot leak, numerous deaths from use of Mylan patches nevertheless have been reported. These deaths may have been as a result of a defective patch.
The FDA is conducting an investigation into over 120 deaths associated with these patches. The Agency has been examining the circumstances of patient patch use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product.
It is possible that some patients may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use. If you are using a Fentanyl pain patch – whether the Duragesic brand or a generic medication from Mylan Laboratories, you should seek medical guidance immediately.