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Duragesic Recall Causes More Patch Woes for J&J

By Jim Edwards | Jan 2, 2009

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 heroin.

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

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

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  •  
    1

    Manabozho

    01/05/09 | Report as spam

    patch technology / analgesics / patient precautions

    Any potency asserted for heroin is meaningless, since
    it is exclusively a street drug of abuse, manufactured
    under un-knowable conditions, and widely variable in
    purity and every other factor. Epidemics of heroin
    death are often due to a change in the potency of the
    street supply. Such comparisons may add unhelpful
    drama to a situation that is already serious. Medical
    professionals typically compare fentanyl's potency to
    that of other legitimate, medically-prescribed narcotic
    analgesics such as morphine, not to street drugs of
    variable potency and purity such as heroin.

    The precautions in the J&J press release are not unique
    to fentanyl--they apply to any transdermal product.
    Soap can reduce the barrier effect of skin oils and
    affect delivery rate, and hot water can make skin more
    permeable and the drug more mobile. Oils and
    solvents in lotions, etc can also intrude into the
    delivery process and affect rates.

    I worked in a non-technical capacity at a company in
    this field.

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