United States of America - The Food and Drug Administration (FDA) is investigating reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product Duragesic® and the generic product. The directions for using the fentanyl skin patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl.

Because fentanyl skin patches are very strong narcotic (opioid) painkillers that may cause death from overdose, they should always be prescribed at the lowest dose needed for pain relief. Fentanyl skin patches should not be used to treat short-term pain, pain that is not constant, or for pain after an operation. They should only be used by patients who are opioid tolerant, or who have chronic pain that is not well controlled with shorter-acting painkillers.

Reference: FDA Public Health advisory http://www.fda.gov/medwatch/SAFETY/2005/duragesic_ddl.pdf