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Fentanyl Patch Lawsuits
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Fentanyl |
Fentanyl is a strong narcotic
painkiller that is now commonly administered in a “patch.” The
Fentanyl Patch is a preferred method of delivery because if the
patch is properly designed, manufactured, and administered, the
dosage of the drug can provide a consistent dose of the drug.
However, recently there have been some recalls of potentially
defective Fentanyl Patches as these defects can lead to
overdoses resulting in death.
If you or a loved one have
been injured or exposed to a damaged Fentanyl Patch seek medical
assistance. If you or a loved one has suffered a serious injury
or have lost a loved one as a result of a damaged Fentanyl
Patch, feel free to e-mail any questions you might have to
toxicdose@texaslawyers.com.
Fentanyl Patch Potential Health Problems
Fentanyl skin
patches provide pain relief for many people who experience
chronic pain, and who have been taking pain medications for long
periods of time. However, the Food and Drug Administration (FDA)
has posted a warning that deaths and other serious problems have
resulted from accidental overdoses related to inappropriate use
of the fentanyl patch.
The Fentanyl patch is applied to the skin and is designed to
deliver fentanyl, a potent, strong opiate analgesic. The drug is
slowly absorbed through the skin into the bloodstream and can
relieve pain for up to three days from a single patch
application.
Please keep in mind that after applying the first patch, it
can take 12 to 18 hours to reach the peak of pain relief, with
some early pain relief occurring at four to six hours after the
first administration.
The FDA is investigating deaths and overdoses that have
occurred with both brand-name and generic fentanyl patches. The
brand Duragesic (fentanyl transdermal system), manufactured by
Janssen L.P. of Titusville, N.J., was approved by the FDA in
1990. A generic version, manufactured by Mylan Laboratories Inc.
of Canonsburg, Pa., was approved in 2005.
Fentanyl Patch Recall
On February 17, 2008, Actavis Inc., the United States
manufacturing and marketing division of the international
generic pharmaceutical company Actavis Group hf, announced that
14 lots of Fentanyl transdermal system CII patches sold in the
United States by Actavis' subsidiary Actavis South Atlantic LLC
were being voluntarily recalled from wholesalers and pharmacies
as a precaution.
The recalled patches were manufactured by Corium
International Inc., a contract manufacturer for Actavis, and
sold nationwide in the United States by Actavis South Atlantic
LLC.
"The 14 lots of Fentanyl transdermal system patches being
recalled may have a fold-over defect which may cause the patch
to leak and expose patients or caregivers directly to the
fentanyl gel. Although unaware of any injuries resulting from
this issue Actavis, as a precaution, is recalling these lots. As
per the approved product labelling for Fentanyl transdermal
system, fentanyl is a potent Schedule II opioid medication.
Fentanyl patches that are leaking or damaged in any way should
not be used. Exposure to fentanyl gel may lead to serious
adverse events, including respiratory depression and possible
overdose, which may be fatal. Anyone who comes in contact with
fentanyl gel should thoroughly rinse exposed skin with large
amounts of water only; do not use soap. Immediately dispose of
affected patches that may be damaged or compromised in any way
by flushing them down the toilet, using caution not to handle
them directly. Damaged and/or compromised patches that have
leaked gel will not provide effective pain relief.
The lots covered by this recall are: 27261 (exp 05/09), 27317
(exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp
06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09),
27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537
(exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the
following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100
mcg/hr.
Please note: Actavis South Atlantic LLC was formerly known as
Abrika Pharmaceuticals Inc. The pouches containing the patches
are labelled with an Abrika Pharmaceuticals label, but the outer
carton bears the Actavis logo with the following product names:
Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC
67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC
67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC
67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC
67767-123-18.
Anyone who has fentanyl patches labelled with an Abrika or
Actavis label should check them for these lot numbers.
Affected patches should not be handled directly.
Anyone with Actavis Fentanyl transdermal system patches with
the above listed lot numbers should call 1 877 422 7452.
Patients using fentanyl patches who have medical questions
should contact their health-care providers.
This recall is being conducted with the knowledge of the Food
and Drug Administration.
Any adverse reactions experienced with the use of this
product, and/or quality problems should also be reported to the
FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at
1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane,
Rockville, MD 20852-9787, or on the MedWatch website at
www.fda.gov/medwatch."
Fentanyl Patch Lawyers
Texas Fentanyl Patch Attorney Jason Coomer
commonly works with other Fentanyl Patch lawyers throughout
Texas and the United States including Houston Fentanyl Patch
Lawyers, Boston Fentanyl Patch Lawyers, San Antonio Fentanyl
Patch Lawyers, Dallas Defective Medication Lawyers, and other
Austin Dangerous Drug Attorneys. By sharing information and
working together, his law firm and other firms throughout Texas
and the United States are able to provide better representation
for there clients.
If you or a loved one have
been injured or exposed to a damaged Fentanyl Patch seek medical
assistance. If you or a loved one has suffered a serious injury
or have lost a loved one as a result of a damaged Fentanyl
Patch, feel free to e-mail any questions you might have to
toxicdose@texaslawyers.com. |
