FDA Issues New Warnings Over Misuse Of Duragesic Patch

The FDA said today that a small number of preventable cases of accidental death have occurred since their first Duragesic warning in 2005, prompting them to ask Johnson & Johnson and the makers of a generic version to add new warnings. “Despite a July 2005 warning, the Food and Drug Administration ‘has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it,’ the agency said.”

Things not to do with Duragesic, according to the agency: don’t use it for “occasional or mild pain, post-surgical pain, or for headaches.” Don’t expose it to high heat, such as in a hot tub, and don’t use more patches than prescribed or apply them more frequently.

Michael Cohen, president of the nonprofit Institute for Safe Medication Practices, said the new FDA warning “will educate some doctors, but it’s not enough. I think we need to do more.” Cohen said other steps could help such as requiring pharmacists to discuss proper use with patients, or having company salespeople do more to get the message to doctors.

Signs of a fentanyl overdose may include breathing trouble, slow or shallow breathing, slow heartbeat, severe sleepiness, cold, clammy skin, trouble walking or talking, or feeling faint, dizzy, or confused. Patients should get immediate medical attention if those signs occur, the FDA said.

“U.S. issues new warning on misuse of J&J pain patch” [Reuters]

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  1. bohemian says:

    Fentanyl patches are supposed to be one of those last option pain medications for things like cancer patients or people with severe chronic pain problems.

    If doctors are handing these out for occasional pain or a headache they need to have their license reviewed.

  2. m4ximusprim3 says:

    For those of us who don’t frequent jezebel, what exactly is a fentanyl patch? Is it uber pain med?

  3. alice_bunnie says:

    This isn’t a problem with the drug, it’s with the doctors not talking with their patients and just whipping out a prescription pad and saying “here!”. Doctors need to talk to their patients.

  4. Trai_Dep says:

    Do not use Duragesic for occasional or mild pain.
    Do not use Duragesic for post-surgical pain.
    Do not use Duragesic for headaches.
    Do not expose Duragesic to high heat, such as in a hot tub.
    Do not use more Duragesic patches than prescribed.
    Do not use apply Duragesic patches more frequently than required.
    Do not expose Duragesic to cold, concrete surfaces.
    All or portions of Duragesic patches consist molten material of unknown and/or extraterrestrial origin.
    Do not taunt Duragesic patches.

  5. DoctorMD says:

    Most patients can’t understand the difference between long and short acting narcotics. Just imagine the folly in getting a patient to understand how to use these patches or even better get “informed consent” for complicated treatments.

  6. PowerLlama says:

    A friend of mine just OD’d a few days ago, and they found two of these on him. =(

  7. PowerLlama says:

    @m4ximusprim3: It’s more powerful than morphine, and due to it being taken in patch form, even after you take off the patch it will still be being absorbed into your skin.

  8. bohemian says:

    I thought they had taken these off the market two years ago. There were some issues with the time release not working right and overdosing people.

  9. chemicalx9 says:

    another good reason to make sure you talk to your doc and / or pharmacist regarding the appopriate use of medications.

  10. Tired_ says:

    I don’t think these patches should be used outside a hospital. On the street, they are easily the most popular and sought-after opiates.

  11. Schizohedron says:

    I recall in 1991 or 1992, when they were first bringing these out on the market, and I was working for a survey firm, interviewing doctors to get their opinions of the product. Fentanyl was an existing tablet-form medicine, but the transdermal patch (or “derm,” as I, steeped in William Gibson’s Sprawl books, called them in my head) was a new delivery system. The vast majority of the MDs mentioned the elevated potential for abuse that these patches possessed. So it’s not like J&J was in the dark on how easily these things could be abused. As one of Gibson’s characters said, “The street finds its own uses for things.”

  12. JiminyChristmas says:

    @Tired_: Many of the people who rely on fentanyl patches for pain control aren’t in hospitals. They’re at home under hospice care because there’s not much the hospital can do for them.

    The patches are really a great palliative measure for those such as cancer victims. The drug delivery is constant and consistent, so you don’t get variations in the degree of pain control as you might with pills.

    Also, pills might not be an option if you’re constantly vomiting or can’t swallow. Likewise, not having to rely on an IV is much more comfortable for the patient and eliminates a potential source of infection.

  13. Chris Walters says:

    @PowerLlama: I hope your friend is okay. And regardless, our sympathies go out to you and him.

  14. jamar0303 says:

    …is this stuff really so powerful that it has to be measured in micrograms?

  15. crazyflanger says:

    I just got some vicodin for a toothache…I should of reemed my dentist until he handed some of these over.

  16. renilyn says:

    @jamar0303: Yes, yes it is. I also used this patch for a chronic pain condition. Unfortunately (or I suppose now after reading this, FORT8UNATELY) it made me very ill. I could take the patch off and wash the area, and feel fine in 20 or so minutes.

    I suppose that all was a blessing. I really feel that drugs like this should NOT be used out of “someones” supervision. It drugs you up so bad that I dont think you have the capability to remove it if you were feeling the symptoms above.

  17. maevro says:

    @jamar0303:

    Yes. Fentanyl is more powerful then heroin.

    I have had clients and friends who just cut the patch open and eat the gel at once. I used to do it too but now I am on the other side of the desk.

  18. drdom says:

    They also make these in a “sucker” form, called fentanyl pops. I used them for breakthrough pain during cancer treatment.They work a little too well, in my opinion. I don’t think fentanil should be administered outside of a hospital. A friend going through similar treatment died of an accidental overdose from the patch. Dangerous stuff.

  19. swalve says:

    Just seconding that this is a drug that is bad stuff. 80x more powerful than Morphine.

    [en.wikipedia.org]

  20. swalve says:

    Bad for abuse, helpful for cancer patients.

  21. swalve says:

    In fact, after I hit submit I remembered that this was the drug used to “cut” the heroin that was causing all those sudden deaths last summer.

  22. Mina_da_mad_child says:

    I also had a friend die from one of these patches. He stole it from his mother, who was in the final stages of cancer. we don’t know if he knew how strong the medication was. He put it on, went to sleep, and never woke up. Instead of burying his wife, he had to bury his 27 yr old son.

  23. AD8BC says:

    More warnings aren’t the answer.

    People don’t read more warnings.

    Instead, we need to let this kind of abuse thin out the gene pool.

  24. Mina_da_mad_child says:

    Your mother should have aborted you when she had the chance you cold and miserable SOB

  25. ladynurse says:

    i agree w/ AD8BC, more warnings aren’t the answer. addicts will abuse whatever they can. i guess benadryl and tylenol “shouldn’t be used unless in a hospital” because addicts use it to make “cheese” being a nurse fentanyl is great at letting people live their lives when perscribed correctly, and i have several patients that would agree.

  26. ladynurse says:

    typed to fast, yes i see my typos

  27. talky says:

    I certainly understand the concern over the abuse of this drug, however, I would be very upset to see this drug off the market because of it. I can’t imagine telling someone chronically ill that they couldn’t have their pain relief anymore because some healthy person down the street is getting high and might overdose. Anyway, if Fentanyl isn’t available, a drug user will just find another drug to use.

  28. King of the Wild Frontier says:

    @bohemian: Yes, and I believe that it is one of the things that can trigger a review. Fentanyl is really meant for people that are already tolerant to opioids, meaning that they’ve been on painkillers for a while.