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Actavis Recalls Certain Fentanyl Patches in the US as Precaution
Morristown, NJ -- February 17, 2008 -- Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are 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.

Fentanyl patches sold by Actavis in Europe are not affected by this recall.

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 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.

Anyone who has fentanyl patches labeled 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.

Fentanyl Pain Patch Recall - Overdose Deaths
NOTE: As of February 12, 2008 the FDA announced a PARTIAL Duragesic Patch Recall. 

Duragesic Press Release from PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc PriCara RECALLS 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII PAIN PATCHES NOTE: Other Strength Patches (12.5, 50, 75 and 100 mcg/hr) NOT Affected.

DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut 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.

• FDA Alerts concerning Duragesic Patches
• FDA Warning of Duragesic - July 2005
• Duragesic Patient Information - July 2005
• FDA Duragesic Alert - Dec. 21, 2007 (1)
• FDA Duragesic Alert - Dec. 21, 2007 (2)
• Duragesic Recall by FDA - Feb. 12, 2008 - (NEW)
• Actavis Fentanyl Patch Recalled - (NEW)

FENTANYL PAIN PATCH LAWYERS IN THE NEWS

Johnson & Johnson Settles Duragesic Patch Lawsuit for $2.5 Million - Johnson & Johnson has agreed to settle wrongful death claims involving its Duragesic pain-killing patch for more than $2.5 million, according to Bloomberg.com. The settlement, paid to the family of a Florida man who overdosed on the opiod painkiller fentanyl while wearing the patch in 2003, was the first awarded by Johnson & Johnson in a case involving the Duragesic patch. Hundreds more wrongful death suits are still in the works. “The settlement indicates that Johnson & Johnson realizes the seriousness of these cases and that they have to pay serious money to resolve them,” Alex MacDonald, a lawyer based in Boston, told Bloomberg.com. MacDonald has four cases involving Duragesic overdoses set to go to trial next year, while as many as 300 to 400 more similar suits have been filed, according to Bloomberg. Johnson & Johnson may now have to consider an all-inclusive settlement for the many pending wrongful death suits, as it has lost both cases that have gone to trial. A jury awarded $772,500 in damages in a suit involving a Texas woman overdosed when her Duragesic patch leaked fentanyl onto her skin instead of administering it in a controlled dose. That case is still under appeal, Bloomberg.com reported.

Jury Awards $5.5M in Duragesic Patch Lawsuit - A jury award of $5.5 million was entered in federal court in West Palm to the father of a man who died while wearing a Duragesic patch. The patch, made by a Johnson & Johnson subsidiary, distributes time-released doses transdermally of the prescription synthetic opiate fentanyl. The decedent’s father found his son dead at his computer in 2003 wearing one of the Duragesic patches. The decedent Adam Hendelson was a chronic pain sufferer and thus a candidate for the Duragesic patch. He suffered from chronic hip pain and wore the patches on his arm. However, an autopsy revealed that he had over three times the suggested therapeutic level of fentanyl in his system at the time of his death.

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Proper Use of Fentanyl Pain Patches - US Food & Drug Administration

The fentanyl patch should not be used for short-term, acute pain, pain that is not constant, or pain after an operation. "The patch is not for pain that occurs after surgery such as tonsillectomies or dental procedures," Meyer says.

The patch is only for people who experience moderate-to-severe chronic pain that is expected to last for weeks or longer and that cannot be managed by acetaminophen-opioid combinations, nonsteroidal analgesics, or as-needed dosing with short-acting opioids.

The patch also shouldn't be the first narcotic pain medicine that is prescribed. It should be used only in people who have been taking opiate analgesics for a period of time. It could be used if people have been taking at least 60 milligrams (mg) of oral morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer. Stanski says, "This prior opiate dosing results in a degree of tolerance, or resistance to the opiate that is relevant when the patch is subsequently used." Children who are younger than 2 years should not use the fentanyl patch. It also shouldn't be used in children 2 years of age or older who are not already using other opioid narcotic pain medicines. Patches should always be prescribed at the lowest dose needed for pain relief.

"Understanding and following directions is so important because of the potential for respiratory depression associated with all opiate analgesic medications, and especially with the fentanyl patch," says Stanski.

Some deaths have occurred because more than one patch was applied at the same time. Other problems associated with the patch include not removing one patch before applying another, and the failure of multiple caregivers to notice that someone else has applied a patch. The patches are clear, relatively transparent, and easily blend into the skin background.

The Institute for Safe Medication Practices (ISMP) received a report of a 77-year-old woman who died in March 2005 after using the fentanyl patch. Her primary care physician called in a prescription for the patch without examining her or educating her about the drug. She did not receive education from the pharmacy either, according to the ISMP's report.