Duragesic Fentanyl Patch Recall
Patients who use the Duragesic pain patch may be exposed to an increased risk of serious Duragesic side effects. 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. Due to problems with manufacturing of the Duragesic pain patch, the patch has been the subject of multiple recalls, although Duragesic patches are still available on the market.
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Duragesic Fentanyl Pain Patch
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
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
Duragesic Pain Patch Lawsuits
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.
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