Duragsesic fentanyl patch recall information dangerous. It has been linked to over 120 deaths due to accidental overdose. Another manufacturer has recalled fentanyl patches, this time in doses ranging from 25 to 100 mcghour, the fda said today. This recall appears to have been caused by a manufacturing defect where the fentanyl patches were not properly put in place when they were cut. Duragesic fentanyl transdermal system for transdermal administration is an opioid analgesic indicated for the management of pain in opioidtolerant patients, severe enough to require daily, aroundtheclock, longterm opioid treatment and for which alternative treatment options are inadequate. Duragesic 50 mcghr fentanyl transdermal system patches and sandoz inc. In december, the fda issued an alert warning patients and doctors that there was a high danger of accidental overdose associated with the use of the duragesic pain patch.
On april 21, the fda announced a recall for an alvogen fentanyl transdermal system over mislabeling issues in some cartons. The patches may have a cut along the side of the reservoir that contains fentanyl gel. Mylan fentanyl pain patch fentanyl duragesic patch lawsuit. The fentanyl transdermal system patch should not be used if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
Fentanyl patchrecalls, deaths, overdoses connected with. It is intended to treat severe chronic pain in people. Duragesic fentanyl transdermal system is available in generic form. A small number of cartons labeled 12 mcgh fentanyl transdermal. Still more fentanyl pain patches recalled medpage today. The duragesic patch is a powerful opioid painkiller, which is worn on the skin for extended periods of time. The duragesic fentanyl patch is intended for severe and chronic pain management that cannot be controlled by less powerful drugs. Patients who use the duragesic pain patch may be exposed to an increased risk of serious duragesic side effects.
Each fentanyl transdermal system patch may be worn continuously for 72 hours. Duragesic fentanyl transdermal system feb 20, 2004. Duragesic is the brand name of a patch that contains the drug fentanyl. Duragesic and generic fentanyl pain patches in the 25 microgramhour mcghr strength with an expiration date on or before december 2009 are being recalled because of possible overdose risk. Studies revealed that fentanyl gel had been leaking from a pocket inside the patch. When contacted by neurology today, company representatives at both manufacturers actavis for fentanyl and pricara for duragesic offered. Duragesic label page 1 full prescribing information for. The duragesic patch contains a powerful fentanyl gel, which is 100times stronger than morphine. Duragesic fentanyl transdermal dosing, indications. Fentanyl painrelief patches recalled for packaging defect acp. Duragesicbrand fentanyl patches, sold by pricara, are also recalled for a similar defect. Duragesic patches being recalled fight colorectal cancer. Fentanyl lawsuit duragesic generic pain patch impact law. This recall includes all duragesic patch strengths.
As of february 12, 2008 the fda announced a partial duragesic patch recall. Fentanyl patches recalled for mislabeling drug topics. I just wanted to inform any of the fentanyl patch users that there has been a recall since december 2008, which i just learned about. The watson recall again raises the question of whether fentanyl patches are too dangerous to be on the market, and whether transdermal patch delivery of drugs generally is. Fentanyl is so strong that its distribution is monitored by the drug enforcement agency. All of the recalled patches were made by alza corp. On february 12th of 2008, pricara announced a recall of 38 million duragesic and generic fentanyl patches because they may have a cut along one side of the drug reservoir within the patch. More duragesic pain patches recalled parker waichman llp. When contacted by neurology today, company representatives at both manufacturers actavis for fentanyl and pricara for duragesic offered no details about specific events that led to the recall.
Fentanyl is used to manage pain for patients who can tolerate opioids. Common questions and answers about duragesic patch recall. In february 2008, there was a fentanyl recall for 95 lots of 25 mcghr duragesic pain patch products and generic sandoz fentanyl patches were recalled because they were not. The transdermal system is pressed firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges. This rtt report says that this is the fifth duragesicfentanyl recall since 1994.
The fda is announcing a nationwide recall of fentanyl duragesic patches. Serious or lifethreatening breathing problems that can lead to death can. The recall does not affect other duragesic strengths. The agency indicated that some cartons labeled as having 12 mcgh patched were actually containing 50 mcgh patches. Fentanyl transdermal system patches are intended for transdermal use on intact skin only.
In addition, there was also a recall of duragesic patches because of possible leaks. Duragesic information, side effects, warnings and recalls. Duragesic painkiller patches contain the active ingredient fentanyl and provide users with up to three days of potent pain relief. Alvogen has notified distributors and customers about the recall through a certified letter and made arrangements for the return and replacement of all recalled products. In addition, all 25mcg duragesic patches with an expiration date that falls on or before december 2009 have been recalled. The schmidt firm, pllc is currently accepting fentanyl patch induced injury cases in all 50 states. The mylan patch is different from the duragesic patch in that it utilizes a matrix design as opposed to a reservoir design. Duragesic patches known generically as fentanyl patches have been linked to a risk of fentanyl overdose, which could result in respiratory failure, permanent coma and death. The recall affects lot 180060 of fentanyl transdermal system 12 mcgh, expiration date 052020. In july of 2005, the fda launched an investigation into the duragesic fentanyl patch after 120 deaths were reported due to use of the fentanyl patch.
Lot 180073 of fentanyl transdermal system, 12 mcgh, expiration. The duragesic recall was issued when it was discovered that some of the patches may contain a defect and leak the extremely powerful drug inside the patch fentanyl, an opiate narcotic that is 80100 times stronger than morphine. On february 12, 2008, fentanyl painkiller patches like duragesic were recalled when it was discovered that a cut in the patchs drug reservoir could cause a harmful overdose. The problem with duragesic patches duragesic patches are capable of giving users up to three consecutive days. The pricara recall pricara announced this recall when the fda brought the effectiveness of the drug into question. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to overdose or death. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients. Only control number 0327192 expiration october 2005 is subject to this recall.
On february 12, 2008, pricara, an affiliate of orthomcneilljanssen pharmaceuticals, issued a recall on its duragesic painkiller patches. The recalled cartons contained 50 mcgh patches instead of 12 mcgh. The fentanyl pain patch recall covers a lot of 100 mcghr patches that were sold in the united states. Duragesic fentanyl patch lawsuit duragesic fentanyl. Two lots of 50 mcgh fentanyl patches are being recalled as a precaution. Voluntary recall of duragesic and generic fentanyl patch due to overdose risk. The fentanyl transdermal system patch is used for the management of persistent, moderate to severe chronic pain in opioidtolerant patients when a continuous, aroundtheclock opioid analgesic. The recall applied to all 25 microgramhour fentanyl patches brand name and generic with expiration dates on. The manufacturer issued a duragesic patch recall in february 2004, and again in april 2004. Pharmacists, other healthcare professionals, and consumers february 20, 2004 janssen pharmaceutica and fda notified healthcare professionals of a class i recall of duragesic 75 mcgh. Applied to the skin, the patch delivers a powerful and constant dose of fentanyl in gel form, providing pain relief for up to 3 days.
Fentanyl recall actavis recalls some 25 mcghour patches. Side effects of duragesic fentanyl transdermal, warnings. Fda announces fentanyl duragesic patch recall youtube. Certain batches were recalled due to faulty seals which could result in the gel leaking out onto the skin. If you use a 25 mcghour fentanyl patch, youll want to check to see if its on this actavis recall. When contacted by neurology today, company representatives at both manufacturers actavis for fentanyl and pricara for duragesic offered no details about specific events that led to the recall, but said the recall was precautionary. Watson pharmaceuticals makes the generic version of the popular fentanyl pain patch duragesic. Duragesic should not be used if the pouch seal is broken or if the patch is cut or damaged. This duragesic patch has been subject to an fda recall and an fda health advisory. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Problems could result in potentially deadly doses of fentanyl being administered to unsuspecting users.
The gel is supposed to be contained within the patch and delivered in a. Fentanyl patch side effects fentanyl patch lawsuit. However, in 2005, the fda issued a warning about a possible link between duragesic patches and death. Tears in a duragesic patch can release too much of the medication at once, resulting in. Duragesic and fentanyl patches in other strengths arent being recalled. Every 25 microgramperhour patch that has been released into retail outlets containing an expiration date of december 2009 or earlier is included.
The duragesic patch recalled again, fentanyl patients. Patients who are opioid tolerant are those receiving, for 1 week or longer, at least 60 mgday morphine, 25 mcgday transdermal fentanyl, 30 mgday po oxycodone, 8 mgday po hydromorphone, 25 mgday po oxymorphone, 60 mgday po hydrocodone, or an equianalgesic dose of another opioid. The recall was issued because defective duragesic patches could have had sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. The patch releases fentanyl, which is a pain medication 80 times stronger than morphine. Fentanyl pain patch wrongful death lawsuit fentanyl. Fentanyl is considered a class ii substance by the drug enforcement administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose. Lot 180060 of fentanyl transdermal system, 12 mcgh, expiration date 052020. Mylan fentanyl patch lawsuit filed over defective pain. Two manufacturers of the analgesic skin patch the fentanyl cii patches issued voluntary recalls of the product in february and march. Durogesic patches sold in europe, latin america, and asia are also not included in the recall. In addition to the duragesic patch recalls, the fda has issued two. Duragesic and generic fentanyl pain patches in the 25 microgramhour mcghr strength with an expiration date on or before december 2009. Fentanyl pain patch death duragesic fentanyl toxicity.