FDA Issues Public Health Warning About Cancer Pain Drug Fentora

The FDA would like to let you know that a medicine meant to be used to control pain in patients who have become tolerant to morphine and other similar drugs is being used incorrectly and some patients have died as a result.

Fentora, a potent opioid pain medication, is used only for treatment of breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it. Breakthrough pain is intense increases in pain that occur with rapid onset, even when opioid pain-control medication is being used. Patients who take narcotic pain medications daily and around-the-clock develop tolerance and are more resistant to the dangerous side effects of these medications than patients who take narcotic pain medication on a less frequent basis.

The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.

“FDA is monitoring this issue very closely,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. “We are working with the manufacturer to ensure the safest use of this medicine. Health care professionals and patients need to be aware of the potential for fatal overdose with the improper use of Fentora.”

In its Public Health Advisory and Health Care Professional Sheet published today, FDA warned physicians and other health care professionals that it is critical to follow product labeling when administering Fentora. FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in patients who are not opioid tolerant.

If your doctor has given you this medicine for a migraine or other pain and you are not tolerant to narcotic painkillers, or you believe that this medicine has been substituted for another medicine improperly, you’ll want to heed this warning. Call your doctor and ask some tough questions.

DA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug [FDA]


Edit Your Comment

  1. Why don’t people just accept the fact that when using this properly BY the right patient it provides a great service.

    I think the FDA issues this stuff in some lame attempt to warn abusers who shouldn’t be getting their hands on the patches in the first place!

    I feel the same way about people suing the OxyContin people, -this is serious medicine- follow directions and start taking some responsibility for your body.

  2. HungryGrrl says:

    Is this the same junk (har har) that a bunch of heroin got cut with, resulting in scores of overdoses in the Northeast US?

  3. teqsundotcom says:

    judging by the name fentora… fentanyl or however you spell it was the stuff they cut heroin with. In some circles it is known as china white.

    Fentanyl is a very very potent opiate many times stronger than heroin. This is a classic case of doctors not knowing what they are dealing with.

    As a former heroin addict, I can tell you that even telling a doctor that you used to use the stuff doesnt make any difference in the way they perscrib you drugs. Hell I went to the er a month ago and they gave me IV Dilaudid even after I told them that I was in recovery.

    I have known several doctors, one oncologist who told me that in medschool they only went through a week course on addiction. That covers tollerence too.

    The doctors today need to get up to par with whats going on… stop ignoring the problems and feeding everyone drugs like they are candy… end rant

  4. lestat730 says:

    @HungryGrrl: it sure is, fentanyl is some hardcore stuff, 1000’s of times more powerful then diacetylmorphine (heroin.) I believe the bags were sold in Philidelphia, PA and Newark, NJ and caused the overdoses because of the massive difference in potency between each substance. Heroin is messured in miligrams while fentanyl is mesured in the much smaller nanograms. While many addicts would love to score fentanyl instead of heroin, not knowing that they are actually getting fentanyl becomes a problem when they take their usual size dosage of heroin. The result will have you dead within 5 minutes without immediate medical care and the administration of Naloxone injections to block the opiates. It hit these groups of addicts completely off guard because heroin purity has remained at a constant level for quite a long time. They were simply not prepared for the huge spike in potency due to the substituted drug. While some may not care about these people, junkies or not… they are human beings.

    Fentanyl is no tylonal with codiene, vidodin (hydrocodone), or percocet (oxycodone.) This stuff is some seriously powerful dope. What’s really messed up is that this insanely powerful opiate is available in lollypop form (brand name is Actiq.)

  5. swalve says:

    I seem to remember a bunch of kids dying in Chicago because of the stuff too.

    Fentanyl is bad stuff. It’s pretty much only for the dying. I am surprised it’s even available in pill form, I thought it was only in patches. Didn’t we learn that with oxycontin? You take percoset/percodan and make it more concentrated? Seriosly, every celebrity who has had a “pill problem” was on these things.

    The sucker is a good idea for patients who need it, a really really bad idea to have out on the street.

  6. Alvis says:

    @teqsundotcom: tolerance fades, though. In a week or two, a heavy opioid user shows no more signs of tolerance. As for psychological issues of addiction, that’s the concern of a shrink, not a medical doctor. You don’t expect your plumber to care about fixing oven, do you?

  7. Alvis says:

    @swalve: No, not really; I know people in chemo, improving instead of getting worse, and they’re getting fentanyl. It’s not to placate the dying, it’s to reduce pain for anyone suffering from it.

  8. Alvis says:

    @lestat730: 1000s of times? Try 80 times. Just eighty. Only one zero. Well within the realm of controlled, measured doses. Opioids get enough bad press as-is. Lay off the fear and lies.

  9. karimagon says:

    I can’t believe they’re dispensing fentanyl as a prescription medicine–that seems very irresponsible to me, given its dangers. Last I’d heard, it was only used in hospitals as an anesthetic for surgery patients.

  10. Hambriq says:


    Seriously? Duragesic (fentanyl patches) are one of the most popular methods for breakthrough pain treatment out there. Because of its controlled nature, in a lot of cases, it sure beats giving someone 120 extra strength Vicodin and trusting them not to take an extra 3 or 4 every day.

    Which brings me to my point… Buccal tablets kind of defeat that purpose of the fentanyl patches. I’m rather leery about this, but at the same time, I’m trying not to be as swift about passing judgment about pain medicines as I used to be. Granted, a lot of people are abusers, but I’ve talked to cancer patients and trauma survivors, and the kind of physical pain they live with makes me shudder. So who knows, maybe this could be a good thing for people living with that kind of pain.

    @Alvis: tolerance fades, though. In a week or two, a heavy opioid user shows no more signs of tolerance. A

    Although I agree with most of what you said, I really have to question this factuality of this statement. Please show me medical literature which backs this up. Anecdotal evidence doesn’t count.

  11. Beerad says:

    As a longtime cancer patient (extremity limb sarcoma), my girlfriend takes a lot of narcotics, including Oxycontin, Actiq (the fentanyl lollipops mentioned above), and Fentora (no, not all at once). She needs them to control her constant debilitating pain, and wouldn’t be able to function without them. She has no plans on dying anytime soon, and would be rather unhappy to hear that people assume she is based on the meds she takes.

    I have never seen such detailed warnings on any other medication in my life. Each box comes with a thick packet of warnings and usage instructions, including lots of capital letters and bold text, which specifically say that the medicine is only to be used for severe cancer pain in patients who have developed a high tolerance for narcotics and that if you aren’t extremely careful in using it you can die.

    I am appalled that this stuff would be prescribed by any doctor (and it probably shouldn’t be by anyone who’s not an oncologist or a pain specialist) for anything other than its intended purpose and without lots of discussion with the recipient. Good looking out for your patients, there.

    @Hambriq: FWIW, she can’t stand the patches. They don’t provide a regular controlled dose (at least not for her) so she’ll feel no relief for a while then suddenly get hit by it all at once and end up nauseous afterwards.

  12. Bobg says:

    It was on NPR this morning that the FDA monitored less than 1% of the clinical trials of the drug companies (they only have 200 inspectors.) Is it any wonder why prescription drugs are killing people? Maybe Michael Moore had the right idea, “The best way to beat this fractured medical system is to not have anything to do with it.”

  13. Hambriq says:

    @Beerad: FWIW, she can’t stand the patches. They don’t provide a regular controlled dose (at least not for her) so she’ll feel no relief for a while then suddenly get hit by it all at once and end up nauseous afterwards.

    Hmm, that sucks. Has she tried both brand name Duragesic and generic Fentanyl patches? Or were they both not any good? Back when I was trying to quit smoking, I had the same problem with nicotine patches, so I can definitely understand where she’s coming from.

    But, I have to say, the only prescriptions I see for fentanyl-containing products generally comes from the local pain management clinic, or are for people who have an established history of using the product. Doctors rarely fuck around when prescribing CII prescriptions (Oxycontin, Adderall, Ritalin, Fentanyl, Morphine, etc. etc.)


    Referencing NPR and Michael Moore in the same post… Was it your intent to sound like a walking cliche?

  14. Beerad says:

    @Bobg: Yeah, I’m kinda puzzled by your comment. Is your suggestion that the FDA should step in and say “Whoa – this is just too much pain relief! Sorry, folks, you’ll just have to suffer.” And it’s apparently not a wonder that people are dying, because they aren’t using the drugs properly or doctors are improperly prescribing them. Not really any problem with clinical trials.

    @Hambriq: Not sure if the patches are brand name or generic. She likes the Fentora because it’s discreet (i.e., you don’t get stared at in public because you’re rubbing a plastic stick on your gums) but insists the Actiq lozenge-lollipop is more effective.

  15. teqsundotcom says:

    I expect when I tell a doctor that I have a problem with opiates that he would think twice about giving them to me. Rather than tell me that its going to make me feel good.

  16. Bobg says:

    BEERAD-The gist of the piece on NPR is that the FDA does not check to see that proper protocols are used in the tests. It waits until the results are submitted and then rules on them. Clinical trials can be skewed by improper procedures. The FDA trusts the drug companies to ensure that everything is on the up and up.