Duragesic Patches

Duragesic patches are designed to go directly on the skin of those suffering from chronic or debilitating pain. The medication is supposed to travel from the patch and into the bloodstream over an extended period of time, delivering consistent relief to the patient. This, however, was not the case for many unsuspecting Duragesic patch users. On July 15, 2005 the FDA issued a public health advisory for defective Duragesic pain patches, in response to a number of deaths and reports of serious side effects.

In 2004, Janssen Pharmaceutical Products, the manufacturer of Duragesic pain patches, recalled their 75mcg strength medication due to a faulty seal. This defect allowed fentanyl to leak uncontrollably from the patch, causing a potentially fatal overdose of the medication. Overdoses of fentanyl have been linked directly to respiratory failure and cardiac arrest.

A manufacturing defect was originally blamed for the alarming number of defective patches. Janssen Pharmaceuticals estimates that following the recall, there were still as many as half a million potentially fatal devices still being used.

Due to the fact that many patients and healthcare providers were unaware of the dangerous side effects caused by this powerful narcotic painkiller, the FDA issued this public health advisory to alert patients and their caregivers:

• Fentanyl skin patches are very strong narcotic (opioid) painkillers that may cause death from overdose. The fentanyl skin patch 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. Fentanyl skin patches should only be used by patients who are already taking other narcotic painkillers, and who have chronic pain that is not well controlled with shorter-acting painkillers.
• Patients who are using the fentanyl skin patch and their caregivers should be told about the directions for safe use of the patch and should follow the directions exactly.
• Patients who are using the fentanyl skin patch and their caregivers should be told about safe methods for storage and disposal of used, unneeded or defective fentanyl skin patches. Fentanyl skin patches should be stored in a safe place and kept out of reach of children.
• Healthcare professionals who prescribe the fentanyl skin patch and patients who use the fentanyl skin patch and their caregivers should be aware of the signs of fentanyl overdose. Signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness; extreme sleepiness or sedation; inability to think, talk, walk normally; feeling faint, dizzy or confused.
• A patient using the fentanyl skin patch may have a sudden and possible dangerous rise in their body level of fentanyl or have a stronger effect from fentanyl if they: use other medicines that affect brain function; drink alcohol; have an increase in body temperature or are exposed to heat; or use other medicines that affect how fentanyl is broken down in the body.

*Information taken from the FDA Public Health Advisory

If you or a loved one have used Duragesic pain patches and have experienced any side effects, contact us immediately at 800-966-4999 or fill out the free case evaluation form to the right of your page for an immediate review of your case.