Many people taking long-acting medication for chronic pain may experience breakthrough pain. Breakthrough pain is severe pain that comes on suddenly, lasts for a short time and is not relieved by the patients’ regular pain reduction management. To help provide relief for persistent pain that cannot be relived with traditional pain killers, some patients may use the Fentanyl TransdermalSystem (Duragesic), a strong, opiate-based analgesic (pain-reducer) that is 60 to 80 times stronger than morphine. If the drug is defective or a patient is sensitive to opiate-based drugs, the direct exposure may cause the drug to release too quickly or excessively, causing injury or even death.
Fentanyl Patch Side Effects
If the patient receives an excess amount of the painkiller, it may lead to an overdose or other severe side effects:
- Muscle rigidity
- Slow or irregular heartbeat
- Slowed breathing
- Trouble breathing
Defective Pain Patches May Be Dangerous
The patch is supposed to deliver the painkiller over time to avoid an overdose; however, cut, damaged or defective pain patches may release the medicine too quickly. In 2008, PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc under the parent company Johnson & Johnson, recalled some batches of the Duragesic and Sandoz Inc. Fentanyl transdermal system patches because of a manufacturing defect. The defect caused a slit in one side of the drug reservoir, creating the possibility of Fentanyl gel leaking out of the packing and exposing patients and caregivers directly to the gel; this direct exposure may then lead to serious side effects, including an overdose and even death.
Pain Patch Recalls and Dangers
The United States Food & Drug Administration (FDA) approved the Fentanyl patch in 1990 to treat severe and chronic pain not manageable by other drugs. In 1995, problems began surfacing with the transdermal patches, and the FDA started demanding labeling changes. The FDA has continued its involvement by issuing warnings and Public Health Advisories. In 2005, they issued an advisory regarding an investigation into 120 patch-related deaths, and in 2009, they sent letters to manufacturers of the pain patch including Novartis; Johnson & Johnson, Ortho-McNeil, Janssen, Pharmaceuticals, Inc; Mylan Technologies; and Actavis. The letters required the manufacturers to develop a Risk Evaluation and Mitigation Strategy (REMS) to show that the drug’s benefits outweighed the potential risks.
In addition to the FDA’s involvement, numerous manufacturing companies have issued recalls due to the potential for harm to patients and caregivers who handle or use the pain patches.
Call 1-888-BURNETTI for Pain Patch Information
Burnetti, P.A.’s affiliated drug litigation attorneys are reviewing potential lawsuit claims for Fentanyl overdoses and death caused by the Fentanyl patch. If you or a loved one has been severely injured by the pain patch, or a family member has died as the result of using a Fentanyl transdermal patch, contact Burnetti, P.A. at 1-888-BURNETTI.
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