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Duragesic Pain Patch
Fentanyl
Fentanyl transdermal pain patch is a prescription based potent Schedule II opioid medication (considered to be 100 times stronger than morphine) which is used in the treatment of moderate to severe chronic pain.
The Fentanyl pain patch was approved by the Food and Drug Administration (FDA) in 1990 as a method for delivering the Fentanyl pain medication.
A brand name of the patch being sold is called the Duragesic patch which is made by Johnson & Johnson. There are now many generic versions available from the companies below:
- Abrika
- Actavis
- Actiq
- Fentora
- Mylan
- Sandoz
- Watson
According to reports from the FDA, Fentanyl - Duragesic - pain patches have been prone to leaking.
If exposure to Fentanyl opiod medication gel poses an overdose situation (skin coming into direct contact with the potent Schedule II opioid on the pain patch), it may lead to serious adverse events, including:
- respiratory distress
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- possible death
- labored and slow breathing
- seizures
- dizziness
- weakness
- unconsciousness
- coma
- fatigue
- cold, clammy skin
- confusion
- tiny pupils
U.S. FDA Action, Warning and Recall
In February 2008, PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals recalled some lots of it Fentanyl pain patches.
In March 2008, Actavis recalled some lots of its Duragesic Fentanyl pain patches.
FDA: Recall Video of Fentanyl/Duragesic
In addition, reports show the number of patches under the recall is in the 100's of thousands.
One particular recall affects the DURAGESIC® patch - sold by Pricara - is the (fentanyl transdermal system) 25 mcg/h, and its generic equivalent sold by Sandoz (expiration December 2009 or earlier). A second recall affects Actavis' patches.
On May 8, 2009, the FDA updated its Public Health Advisory in connection with the warning that some transdermal medication patches may be unsafe to wear during MRI procedures, including Fentanyl patches.
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