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Duragesic Recall Causes More Patch Woes for J&J

Johnson & Johnson's PriCara unit is recalling two lots of its Duragesic fentanyl pain patch, according to the WSJ. The patch is used for opioid-tolerant patients who need round-the-clock pain relief. Fentanyl is also highly addictive. J&J's history of skin-patch-based medicine delivery systems is an unfortunate one:

  • duragesic.jpgThe company also issued a similar recall in February for a larger batch of patches.
  • This RTT report says that this is the fifth Duragesic/fentanyl recall since 1994.*
  • BNET readers know that J&J has lost at least three lawsuits in which there were fatalities involving patch overdoses.
  • A different J&J patch, the Ortho Evra birth control patch, has also had excess-delivery-of-drug problems. J&J paid $68 million to settled hundreds of cases in which plaintiffs claimed they had ben given strokes, embolisms and heart attacks by Ortho Evra. (Estrogen-based birth control increases blood-clot risks.)
  • That patch allegedly killed 40 women, and the company stopped actively marketing Ortho Evra -- although the product remains on the market.
To give you an idea of how easily things can go wrong with the Duragesic patch, here's a quote from J&J's press release:
Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only; do not use soap, alcohol, lotions, oils or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin.
Bear in mind that fentanyl is about 100 times more potent than morphine.

* Is this true? Contact me if you have better information.

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