Safe Disposal of Fentanyl Transdermal System "Patches" The fentanyl transdermal system “patch” (Duragesic® and its generics) always must be stored, used and disposed of carefully. Fentanyl is a strong medicine used to relieve severe pain. The patch should be handled only by the patient and the patient’s caregivers--before use, during use and after use. A new patch contains a 3-day supply of fentanyl. A patch worn by the patient for 3 days still contains enough fentanyl to cause harm or death in a child or pet. For more information on safe use and disposing of these patches, see: Fentanyl Transdermal System (marketed as Duragesic) Information and Disposal of Unused Medicines: What You Should Know

 


 

Fentanyl

Information for Healthcare Professionals: Fentanyl Transdermal System (marketed as Duragesic and generics) - 12/21/2007 Update FDA ALERT 7/15/2005; Update 12/21/2007:

This update highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system.

In July 2005, FDA issued a Public Health Advisory and Information for Healthcare Professionals that emphasized the appropriate and safe use of the fentanyl transdermal system (fentanyl patch), marketed as Duragesic and generics). Despite these efforts FDA has continued 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 in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant. Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. The directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose. These directions are provided in the current prescribing information and Instructions for Applying a Fentanyl Transdermal Patch and the new Medication Guide for patients.

 

Safety of fentanyl transdermal patches 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