Actavis Fentanyl Pain Patch
Fentanyl is an opioid pain medication that is up
to 100 times more powerful than morphine. It is used to treat patients
suffering from moderate to severe chronic pain. The patch is most often prescribed
for people with cancer. The fentanyl
transdermal patch was approved by
the Food & Drug Administration
(FDA) in 1990 for people with persistent to moderate severe pain.
The
Actavis Fentanyl Transdermal System is manufactured by Actavis
South Atlantic LLC ,
formerly known as Abrika Pharmaceuticals Inc. Transdermal pain patches
have a reservoir containing a 3-day dose of fentanyl gel. The
FDA has received hundreds of reports of fatalities linked to the use of fentanyl
transdermal pain patches. The cause of these deaths can be due to seal breaches
allowing fentanyl gel to leak from the patch, known as the “fold-over
defect,” malfunction
of the rate control membrane or other defects.
Patients and caregivers who come in contact with a leaking patch may experience severe side effects, or potentially be victims of a fatal overdose. In addition to reports of leaking patches, the FDA has investigated deaths and life-threatening side effects in patients who never should have been prescribed the patch. In December, 2007, reports of improper prescribing of the patch prompted the FDA to issue its second Public Health Advisory regarding fentanyl pain patches, which stated that "reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed."
The FDA’s warning to doctors and patients on the symptoms of fentanyl overdose included the following:
• Trouble with breathing, or slow or shallow breathing
• Slow heartbeat
• Severe sleepiness
• Cold, clammy skin
• Trouble with walking or talking
• Feeling faint, dizzy, or confused
According to the FDA, patients using the fentanyl patch who experience those symptoms should get medical attention right away. Additionally, patients or caregivers should call the patient's doctor immediately if the patient's temperature exceeds 102 degrees while wearing a fentanyl patch.
Heygood, Orr, Reyes, Pearson & Bartolomei is the 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 questionnaire to the right of this page for a free consultation.
ACTAVIS RECALLS:
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 recalled. The recalled Actavis patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC. These patches were recalled as a precaution due to a potential fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. However, there were no apparent injuries resulting from the use of Actavis. Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labeled 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.
In its announcement of this recall on February 17, 2008, the FDA stated, “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.”
COMPLETE RECALLS & WARNINGS ARCHIVE>>
The
Actavis Fentanyl Transdermal System is manufactured by Actavis
South Atlantic LLC ,
formerly known as Abrika Pharmaceuticals Inc. Transdermal pain patches
have a reservoir containing a 3-day dose of fentanyl gel. The
FDA has received hundreds of reports of fatalities linked to the use of fentanyl
transdermal pain patches. The cause of these deaths can be due to seal breaches
allowing fentanyl gel to leak from the patch, known as the “fold-over
defect,” malfunction
of the rate control membrane or other defects.Patients and caregivers who come in contact with a leaking patch may experience severe side effects, or potentially be victims of a fatal overdose. In addition to reports of leaking patches, the FDA has investigated deaths and life-threatening side effects in patients who never should have been prescribed the patch. In December, 2007, reports of improper prescribing of the patch prompted the FDA to issue its second Public Health Advisory regarding fentanyl pain patches, which stated that "reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed."
The FDA’s warning to doctors and patients on the symptoms of fentanyl overdose included the following:
• Trouble with breathing, or slow or shallow breathing
• Slow heartbeat
• Severe sleepiness
• Cold, clammy skin
• Trouble with walking or talking
• Feeling faint, dizzy, or confused
According to the FDA, patients using the fentanyl patch who experience those symptoms should get medical attention right away. Additionally, patients or caregivers should call the patient's doctor immediately if the patient's temperature exceeds 102 degrees while wearing a fentanyl patch.
Heygood, Orr, Reyes, Pearson & Bartolomei is the 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 questionnaire to the right of this page for a free consultation.
ACTAVIS RECALLS:
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 recalled. The recalled Actavis patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC. These patches were recalled as a precaution due to a potential fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. However, there were no apparent injuries resulting from the use of Actavis. Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labeled 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.
In its announcement of this recall on February 17, 2008, the FDA stated, “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.”
COMPLETE RECALLS & WARNINGS ARCHIVE>>
Fentanyl News
& Warnings
& 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...