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drug_recall fentanylFentanyl side effects have the potential to cause discomfort, injury, and even death in patients. Pre-marketing clinical trials have found dozens of Fentanyl side effects that can be experienced by patients taking this powerful opioid medication. The most serious and life threatening Fentanyl side effects occur when an individual overdoses on this medication.
Hundreds of deaths have been linked to overdose of the Fentanyl patch (brand name Duragesic). In response to these reports, the FDA issued a public health advisory and ordered the strengthening of safety labeling about Fentanyl side effects and overdose risks. Experts are currently investigating reports to determine whether these patient deaths are attributable to improper use of the patch or the quality of the product itself.
Fentanyl, manufactured by Janssen Pharmaceuticals, was approved by the FDA to treat long term pain in patients who have not achieved adequate pain control through use of similar medications. The Fentanyl patch is designed to deliver a consistent dose of medication over a period of 72 hours. It is important that a patient learn proper application, storage and disposal of the patch. Patients should keep this medication out of reach of children and anyone for whom the medication is not prescribed.
Pre-marketing clinical trials produced reports of numerous Fentanyl side effects in adult and pediatric participants. More than 500 adult patients participated in clinical studies to determine the safety and effectiveness of the Fentanyl patch. The results indicated that the following Fentanyl side effects were experienced by more than ten percent of these participants: excessive sweating, fatigue, nausea, vomiting, constipation, dry mouth, weakness, and confusion. The following Fentanyl side effects were experienced by more that three percent of clinical trial participants: headache, loss of appetite, diarrhea, dizziness, nervousness, hallucinations, and breathing problems.
Pre-marketing clinical trials were also conducted on a pediatric population of 291 children with chronic pain. The most common Fentanyl side effects reported in this patient population include fever, vomiting, and nausea. These young participants also reported the following Fentanyl side effects with significant frequency: headache, sleepiness, anxiety, weakness, insomnia, local itching and patch site skin reactions.
The most deadly of all Fentanyl side effects are those that accompany a drug overdose. Symptoms of a Fentanyl overdose are characteristic of central nervous system depression and can include: slowed breathing and heartbeat, pinpoint pupils, cold clammy skin, loss of or change in consciousness, seizures, and other Fentanyl side effects. A Fentanyl overdose can be deadly; therefore it is crucial that the patient receive immediate medical attention. If you have experienced non-life threatening Fentanyl side effects, you may wish to speak with your physician, who can discuss your questions and concerns in greater detail. If you or a loved one has suffered serious injury or illness from Fentanyl side effects, please contact us to speak with a qualified and experienced attorney who can evaluate your case to determine and protect your legal rights and options.
Actavis Inc. has expanded its recent recall of fentanyl painkiller patches to include all lots sold in the United States. The company said the expansion is a precautionary measure because it cannot guarantee that all patches are without defect.
Another fentanyl patch recall was issued on Monday over a defect that could cause the patches to leak. This is the second recall issued for the prescription patches in the p...
Approximately 32 million fentanyl-containing pain patches are being recalled by Johnson & Johnson over a manufacturing flaw that could lead to unintentional overdose.
The patches, sold under the brand name » Read More