Some lawsuits filed against the makers of fentanyl pain patches have resulted in million-dollar verdicts for the plaintiffs. The lawsuits allege some patients died after too much fentanyl was absorbed by their body, causing them to go into respiratory distress. Several recalls of various fentanyl patches have been announced, after the patches were found to be defective, with holes that allowed the fentanyl gel to come into direct contact with the patient's skin.
In other cases, patients report that they were not warned that certain conditions would cause their bodies to absorb the fentanyl more quickly. For example, having a hot bath while wearing the fentanyl patch can cause the patch to release the fentanyl too quickly, causing the patient's heart to stop, or direct exposure of the fentanyl gel to the patient's skin can cause an overdose.
Fentanyl patches are approved for management of moderate to severe, continuous pain that cannot be managed by other treatments or medications. The US Food and Drug Administration (FDA) approved the patches in 1990 for patients who are opioid tolerant.
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Patients have been advised that they must use fentanyl patches exactly as directed on the information package—meaning the patches should not be overlapped and should not have heat applied. Meanwhile, doctors have been warned not to prescribe the patches for less serious situations, such as headaches or after surgery. Signs of a fentanyl overdose include trouble breathing, slow heartbeat, trouble walking, severe sleepiness and cold, clammy skin.
A fentanyl overdose can be lethal and can affect any patient who is using the pain patch, regardless of age or of how long the patch has been prescribed. Although there are reports of patients using the patch incorrectly, many lawsuits allege the patient used the patch as directed but still suffered an overdose.