Mylan Fentanyl Pain Patch
Fentanyl is an opioid pain medication that is 100 times more powerful than morphine. The fentanyl
transdermal patch was approved by
the Food & Drug Administration
(FDA) in 1990 for people with persistent moderate to severe pain.
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 the matrix design as opposed to the
reservoir design.
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.
Heygood, Orr, Reyes, Pearson & Bartolomei is the nation's leading law
firm in litigation involving fentanyl transdermal pain patches. On June 19,
2007, a $5.5
million jury verdict was awarded in a case against Johnson & Johnson
and its subsidiary, Alza Corporation, the manufacturers of the Duragesic
fentanyl transdermal pain patch. This case, the first
Federal trial involving the Duragesic fentanyl patch, was tried in
the Federal District Court for the Southern District of Florida, West
Palm Beach Division. The verdict was achieved for the family of a 28-year-old
Florida man (Adam Hendelson) who died while wearing a Duragesic fentanyl
drug patch.
If you or a loved one has suffered injury, or a family member has died as
a result of using any brand of fentanyl transdermal pain patch, please fill
out our case review form to the right of this page for a free consultation.
Fentanyl News
& Warnings
Actavis Recalls Certain Fentanyl Patches
in the US as Precaution
2/17/08 - Actavis, Inc. Press Release
Read the article...
PRICARA™ Recalls 25 mcg/hr Duragesic® (fentanyl
transdermal system) CII Pain Patches
2/12/08 - Johnson & Johnson Press Release
Read the article...
Second Safety Warning on Fentanyl Skin Patch
12/21/07 - FDA
Read the article...
$5.5 Million Award in First Federal Fentanyl Patch Trial
6/19/07 - PRNewsWire
Read the article...
Jury Deciding if Pain Patch Leaked, Killing
Man, 28
6/19/07 - Palm Beach Post
Read the article...