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Duragesic Fentanyl Patch Recall
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Duragesic Fentanyl Pain Patch
The Duragesic fentanyl patch is used to treat chronic pain by supplying a steady dose of fentanyl (a powerful opioid pain medication) over an extended period of time—usually up to 72 hours. Patients who use the patch typically have chronic and/or debilitating pain that is not controlled with shorter-acting painkillers and have a tolerance to opioid treatment.
According to the FDA, fentanyl is approximately 80 times stronger than morphine. A fentanyl FDA bulletin warns that for patients who are not opioid-tolerant, the amount of fentanyl in one patch of even the lowest strength is enough to cause dangerous side effects, including respiratory depression and death.
Due to the dangerous nature of the drug, in June 2005 the Duragesic product label was given a black-box warning label explaining the risk of accidental fatal overdose and respiratory depression or hypoventilation. Patients and their caregivers have been advised to follow directions exactly from the patient package insert.
Furthermore, patients could be at risk of developing serious fentanyl side effects if the fentanyl gel comes in direct contact with the skin or if they apply the patch more frequently than recommended. Either situation could result in high levels of fentanyl in the patient's blood.
Fentanyl Patch Recall
A fentanyl patch recall was announced on December 31, 2008. The manufacturer identified a problem with the manufacturing equipment that was causing patches to have a cut edge and a possible release of fentanyl gel.
This was the fifth fentanyl transdermal pain patch recall since 1994. In February 2008, there was a fentanyl recall for 95 lots of 25 mcg/hr Duragesic pain patch products and generic Sandoz fentanyl patches were recalled because they were not properly cut. Just one month later, another drug company, Actavis Inc., announced that its subsidiary (Actavis South Atlantic LLC) was proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of fentanyl transdermal system CII patches sold in the US.
Despite these recalls, fentanyl pain patches and Duragesic pain patches are available on the market. The Duragesic-brand patch is manufactured by Alza Corp. and marketed by Janssen Pharmaceutica, which are both owned by Johnson & Johnson. A generic version of the pain patch is made by Sandoz.
Duragesic Side Effects
Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency. The opioid drug stays in the system for up to 72 hours. As well, there are warnings of withdrawal side effects and potential damage to the cardiovascular system (bradycardia) and the central nervous system. Long-term side effects of Fentanyl are not known.
Duragesic Pain Patch Lawsuits
In the wake of the Duragesic recalls and reports of death linked to use of the pain patch, hundreds of lawsuits have been filed against the manufacturers of fentanyl pain patches. In the first four fentanyl lawsuits that went to trial, the drug maker was ordered to pay more than $35 million to the families of individuals who died.
Recently, an appeals court upheld an award of $13.3 million to the estate of a 34-year-old mother who died of a fentanyl overdose reportedly caused by a faulty Duragesic patch.
Duragesic Fentanyl Patch Legal HelpIf you or a loved one has suffered illness, overdose, or injury as a result of using this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Aug-18-12
DURAGESIC FENTANYL PATCH LEGAL ARTICLES AND INTERVIEWS
Fentanyl Patch Kills Tot, Fentanyl Lawsuit Launched
Deerfield, WI: "He was just being a little boy." The pained words of a mother lamenting the needless loss of her two-year-old son to the cruelty of a fentanyl patch that had fallen into the wrong hands. Fentanyl patches contain a powerful narcotic designed to ease intense and chronic pain. But they have to be handled with kid gloves, because fentanyl patches can kill [READ MORE]
Lawsuit Filed Against Fentanyl Patch Maker
Philadelphia, PA: Another lawsuit has been filed against the maker of a fentanyl pain patch alleging the patch was dangerous and caused the death of a woman. The wrongful death lawsuit, filed by the deceased's sister, was filed against the makers of fentanyl patches, including Alza Corp., Sandoz Inc and Novartis. Fentanyl, sold under the Duragesic pain patch brand name, is a highly potent painkiller that has been linked to other deaths [READ MORE]
Duragesic Fentanyl Patches Could Put Patients At Risk
Fort Worth, TX: For patients dealing with severe, debilitating pain, the Duragesic patch may be their only hope. After all, the fentanyl Duragesic patch is meant to be used in patients who are tolerant to other pain medications and who have chronic pain. In such cases, the strength of fentanyl may be warranted to help patients cope. But the fentanyl patches are so strong that they can be deadly if used incorrectly or if they get into the wrong hands [READ MORE]
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