Duragesic Fentanyl Patches Recalled Due to Defects and Reports of Overdosing and Death

Duragesic patches are medicated adhesive patches that are applied to the skin and designed to provide continuous relief against moderate to severe chronic pain. The patches are designed to release a small but effective and constant dose of fentanyl which is an extremely potent pain killer. Tragically, the FDA has received hundreds of reports of deaths linked to the use of duragesic fentanyl patches. Some of the injuries and deaths may be due to defects in the patches which may cause overdosing and serious injury or death.

In response to reports of fentanyl overdosing injuries and deaths, the FDA has issued a public health advisory. In addition, duragesic patch manufacturers have recalled certain lots that may contain defective patches.

Signs of a fentanyl overdose include, shallow breath or difficulty breathing, extreme sleepiness, inability to walk or talk normally, feeling faint or dizzy, and confusion. Removing a fentanyl patch will not immediately reverse an overdose as the drug may continue to be absorbed into the body more than 17 hours hours after the patch is removed. Therefore, people who use a pain patch should immediately seek emergency medical attention if they experience these or any other unusual side effects.

If you or a loved one suffered serious side effects or injury following the use of a duragesic pain patch, please contact us for a free and confidential case review.

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RECALL NOTICES

8/8/2008: Watson Announces Limited Recall Of Fentanyl

CORONA, CA - August 8, 2008 - Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that one lot of 75 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. The recalled patches are from Lot Number 92461850, have expiration dates of August 31, 2009 and were manufactured by Watson Laboratories, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between January 30, 2008 and March 19, 2008. No other strengths or lots were affected and the Company does not anticipate any product shortages as a result of this recall. The Company has notified the U.S. Food and Drug Administration (FDA) of the recall.

A small number of patches leaking fentanyl gel have been detected in this lot, potentially exposing patients or caregivers directly to fentanyl gel. Fentanyl patches that are leaking should not be used. No injuries have been reported in connection with the recalled lot. However, exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.

Anyone who has 75 mcg/hr Fentanyl Transdermal System patches should check the box or foil pouch for the lot number and expiration date to see if they have patches that are being recalled. Affected patches should not be handled directly.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

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3/1/2008: Actavis Recalls Remaining Fentanyl Patches in the US as Precaution

FOR IMMEDIATE RELEASE -- Morristown, NJ, March 1, 2008 -- Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.

This recall is an expansion of the Company's initial recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.

All of the recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States.

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

As per the approved product labeling 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.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches may be 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.

The lots covered by this recall have expiration dates between May 2009 and December 2009. Anyone who has fentanyl patches labeled with an Abrika or Actavis label should check them for these expiration dates.

ACTAVIS DURAGESIC PATCHES - RECALLED LOTS

Lot	Exp. Date	NDC	Strength
27540	Aug 09	67767-120-18	25mcg/hr
27584	Aug 09	67767-120-18	25mcg/hr
27666	Sep 09	67767-120-18	25mcg/hr
27759	Oct 09	67767-120-18	25mcg/hr
27611	Oct 09	67767-120-18	25mcg/hr
27762	Oct 09	67767-120-18	25mcg/hr
27761	Oct 09	67767-120-18	25mcg/hr
27832	Nov 09	67767-120-18	25mcg/hr
27747	Nov 09	67767-120-18	25mcg/hr
27758	Nov 09	67767-120-18	25mcg/hr
27903	Dec 09	67767-120-18	25mcg/hr
27573	Sep 09	67767-121-18	50mcg/hr
27576	Sep 09	67767-121-18	50mcg/hr
27667	Oct 09	67767-121-18	50mcg/hr
27668	Oct 09	67767-121-18	50mcg/hr
27581	Oct 09	67767-121-18	50mcg/hr
27763	Oct 09	67767-121-18	50mcg/hr
27751	Nov 09	67767-121-18	50mcg/hr
27586	Aug 09	67767-122-18	75mcg/hr
27572	Sep 09	67767-122-18	75mcg/hr
27582	Oct 09	67767-122-18	75mcg/hr
27583	Oct 09	67767-122-18	75mcg/hr
27745	Oct 09	67767-122-18	75mcg/hr
27746	Oct 09	67767-122-18	75mcg/hr
27539	Aug 09	67767-123-18	100mcg/hr
27574	Sep 09	67767-123-18	100mcg/hr
27575	Sep 09	67767-123-18	100mcg/hr
27577	Sep 09	67767-123-18	100mcg/hr
27578	Oct 09	67767-123-18	100mcg/hr
27579	Oct 09	67767-123-18	100mcg/hr
27580	Oct 09	67767-123-18	100mcg/hr
27610	Oct 09	67767-123-18	100mcg/hr
27612	Oct 09	67767-123-18	100mcg/hr
27743	Oct 09	67767-123-18	100mcg/hr

 

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2/17/2008: Actavis Recalls Certain Fentanyl Patches in the US as Precaution

FOR IMMEDIATE RELEASE -- 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 labeling 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.

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2/12/2008: PRICARA™ RECALLS 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII PAIN PATCHES

FOR IMMEDIATE RELEASE -- Raritan, NJ – February 12, 2008 – PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.

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. 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 with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.

Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

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INFORMATION, ADVISORIES & ALERTS FROM THE FDA

12/21/2007: FDA Public Health Advisory - Important Information for the Safe Use of Fentanyl Transdermal System (Patch)

FDA is issuing this public health advisory to alert patients, caregivers, and healthcare professionals to important information on the safe use of the fentanyl transdermal system, also known as the fentanyl patch (marketed as Duragesic and generics). The fentanyl patch is a narcotic (opioid) pain medicine applied to the skin for treating persistent moderate to severe pain in opioid-tolerant patients who need to be on a narcotic pain medicine around-the-clock for more than a few days.

Despite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch. The 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. In addition, the reports indicate that patients are continuing to incorrectly use the fentanyl patch by replacing the patch more frequently than directed in the fentanyl patch instructions, applying more patches than prescribed, or applying a heat source to the patch, all resulting in dangerously high fentanyl levels in the blood.

The fentanyl patch contains fentanyl, a very potent narcotic pain medicine. It is only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. This is extremely important because patients who are opioid-tolerant are more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally take these medicines. For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death.

FDA is highlighting the following important safety information on the fentanyl skin patch:

• The fentanyl patch should only be used by patients who are opioid-tolerant and have chronic pain that is not well controlled with other pain medicines. They are not to be used to treat sudden, occasional, or mild pain or pain after surgery.
• Healthcare professionals who prescribe and patients who use the fentanyl patch should be aware of the signs of fentanyl overdose including the following: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients or their caregivers should get medical attention right away.
• Patients prescribed the fentanyl patch should tell their doctor about all the medicines that they take. Some medicines may interact with fentanyl causing dangerously high fentanyl blood levels and serious, life-threatening breathing problems.
• Patients and their caregivers should be told how to use the fentanyl patch. This important information, including instructions on how often to apply the patch, reapplying a patch that has fallen off, replacing a patch, and disposing of the patch, is provided in the patient information that comes with the fentanyl patch.
• Heat may increase the amount of fentanyl that reaches the blood and can cause life-threatening breathing problems and death.
  • Patients should not use heat sources such as heating pads, electric blankets, saunas, or heated waterbeds or take hot baths or sun bathe while wearing a patch.
  • A patient or caregiver should call the patient's doctor right away if the patient has a fever higher than 102ºF while wearing a patch.

FDA is asking the manufacturers of all fentanyl patches to update the information for fentanyl patches and to develop a Medication Guide for patients. FDA will provide updates as new information is available.