Safety Alerts & Recalls
What does this mean?
This information update highlights the importance of using your medications as directed. Before using this product make sure you have read and understood the patient information provided with your medication, and make sure that you do not add more patches than directed, do not expose the patches to excessive heat, and do not change the patches too frequently.
Drug information update on Fentanyl Transdermal System (marketed as Duragesic)
The FDA today issued a drug information update reemphasizing the appropriate and safe use of the fentanyl transdermal system (fentanyl patch), marketed as Duragesic and generics). Despite previous communications, the FDA has continued to receive reports of life-threatening problems related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in patients that were not using the product as directed.
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.
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