The FDA continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain. Patients have been reported to overdose on fentanyl when the patch malfunctions and releases toxic amounts of fentanyl to the patient. This can occur due to the patch folding over, heating up, or when the patch leaks. Many of these pain patches have been recalled due to defects that caused overdelivery of the drug to the patient.

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