FDA Warning: Fentanyl Patch
December 24, 2007 by Marijke Durning, RN
Filed under Diseases & Conditions
The FDA (the US Food and Drug Administration) has issued its second warning about a medication, the Fentanyl skin patch. Fentanyl is a restricted medication that should only be used for moderate to severe long-term pain, however, some doctors are prescribing it for shorter term pain, such as relief following surgery.
Fentanyl is a great medication for thousands of people who are receiving it for the right reason; however, if it is being used incorrectly, it can lead to overdose and death.
In Canada, fentanyl skin patches go by the brand name Duragesic®.
When I was in Georgia, the pain management specialists that I was seeing were trying to get me off of tramadol and oxycodone. They first tried long acting versions of tramadole and then morphine – both were far too sedating for me to function at work. Then they decided on the fentanyl patch. I didn’t think to question it until I returned to Maryland and saw my regular physiatrist. He didn’t quite hit the ceiling, but it was close. Essentially, the problem was that I needed to go back on tramadol, and then oxycodone, to manage break-through pain. The point that my doctor made to me was that once I developed tolerance to fentanyl, my treatment options would be even more limited. We agreed that I should down-titrate off of the fentanyl patch and continue with just the tramadol and oxycodone.
Fentanyl patches are more for people who have severe pain that is unresponsive to other pain medications/narcotics. Usually, this means cancer patients, NOT chronic pain patients. It can be used for the short-term treatment of acute pain, such as from a broken back, but not for general long-term treatment of chronic non-cancer pain.
On the contrary, chronic pain patients are the group for which fentanyl is most appropriate. We are in constant severe pain and, since we DON’T have death to look forward to to end our pain to, like cancer patients do–be it 5 weeks, 5 months, 5 years…The pain will end fairly quickly for them. I’m 49 years old. If I live a normal lifespan for a woman I will suffer with this horror for 35 or more years. With tramodol or breakthrough pain.
I came out of an accident with a compressed vertebra my doctor gave me Fentanyl Patch because my pain was servere, when I used the patch I felt so sick I was vomitting, headache fainting, constipated, could not swallow, dizzy and very disoiented. I stop using the patch and very concern about my health and reverted to my original pain medicine.
And that is exactly my point. Fentanyl patches are not appropriate for acut pain–as after an accident. They are appropriate for those of us with long-term chronic pain who have been taking large quantities of oral narcotic pain meds for years without adequate relief. If I take hydrocodone every six hours and it’s relief lasts three hours–I spend half my life in indescribable pain. My fentanyl patch constantly delivers small amounts of medication so I seldom have unbearable pain. ( Nothing gets my pain level below 2-3 on a scale of one to 10.) On the rare occasions I do–the hydrocodone is still there. You were an inappropriate candidate for fentanyl patches–both the packagine and the previous post stress they are never to be gven to anyone who has not been taking strong narcotics (like hydrocodone, morphine oxycodone) for YEARS. I am less disoriented than I ever was on hydrocodone, not dizzy at all, and have got long past ALL NARCOTIC’s tendancy to upset my stomach or cause constipation. Fentanyl is a godsend for those of us who used to spend half our lives zonked out on hydrocodone and the other half praying for the time to pass when we could take more. Thats when we weren’t begging God to take this terrible disease away from me. I am not afraid of dying. I am afraid of living with fibro pain for thirty more years.
You are correct. No competent doctor should have given you fentanyl patches. You are not an appropriate patient. Find a competent doctor. Ge the pain rekief correct for your pain. Bur remember that doesn’t make fentanyl right for my pain. For me? It has saved my life.
Be very careful with Fentanyl. You could overdose.
Not to worry. I am a nurse. I use fentanyl as it is intended to be used and I am an appropriate candidate for it’s use as I have constant intractable pain that has been treated with narcotics for many years. Exactly the people fentanyl patches are meant for. As with ALL medications, not every one is appropriate for everyone. Mala’s problem was she started fentanyl patches but had not been taking large quantities of narcotics for many years before she started it, as I and anyone who is appropriately on it has. You would be more appropriate in warning me to be careful with the hydrocodone I use for breakthrough pain as it is far more dangerous and far more disorienting.
A few things concerning Fentanyl patches. One, they rotted all of my teeth within one year. I currently have two molars broken in two. I take 100 mcg per hour. The patches only last 36 hours, not the 72 they are supposed to. I still have to take Norco every four hours or go into severe flu like symptoms (withdrawal). I spend half my life in very sever pain, the other half in moderate pain, even with both of these narcotics. I, after seeing a new pain Dr. have decided to have a morphine pump installed. The amount of narcotics is much less because the morphine is directly sent to the offending nerve damage in my spine (result of severe auto accident and subsequent two level spinal fusion). I can no longer handle the withdrawal so I am opting for a method of delivery which is constant, and sufficient to handle my pain. I will let everyone know how that turns out. God bless you all, and I hope you find a solution to your problems.
Thank you for your good wishes. I have found a solution to my pain–it is fentanyl transdermal /c tramadol and/or hydrocodone to manage breakthrough pain. It has taken me from barely able to get out of bed on my best days to, when things got bad, unable to get up for days at a time to WORKING FULL TIME and really living instead of just surviving.
It is impossible for a 72 hour patch to stop working at 36 hours. The membrane allows a set amount to pass into your syste constantly and it contains enough medication to put that amount of medication into your system for 100 hours. I know this to be true as on 2 occasions I was unable to fill my prescription on the correct day and was perfectly fine–no pain flareup or withdrawl–using a patch for a fourth day. Temperature slightly affects the speed with which the drug enters the system so you should take care if you get overheated or run a fever, but again, this has not been a problem for me.
That said, it does appear that a pump I’d a better answer for you. If a specific spot in your nervous system is responsible for your pain, targeting that spot is CLEARLY better. In my case, the entire nervous system is hyperreactive, so a systemic approach is necessary. Fentanyl patches are ideal because I get a constant serum level, without the ups and downs of oral medications.
No medication is right for every person’s pain. I’m glad you found what’s best for you. Stop assuming you know what’s best for me. Fentanyl Transdermal is constant and a level sufficient to handle my pain. It gave me back my life.
Hi Spooky and everyone, hope you are all doing well.
Spooky, you were spot on when you said “no medication/s are right for every person’s pain”.
I am not sure what you meant when you said “stop assuming I know what’s best for you”. I re-read my post and could not find where I said anything about what is best for you. I only spoke of my experiences.
When talking with the neuro-pain specialist, he agreed that many people complain that the patch does not work for them for the full 72 hours, and we talked about the possibility that the heavy sweat that covers me completely during periods of withdrawal from either Fentanyl or Norco might have an effect on the length of time the patch works for me and others. I fully expect that for most people the patch works for the 72 hour expectancy, but not for everyone.
He seemed to agree that my theory was possible. I can only speak for myself, but just today I was prescribed the same patch (100 Mcg per hour), but to be changed every 48 hours. My internist believes that will help also.
Ultimately my doctors and I decided to see how this works out before going the morphine pump route, because the pump can be problematic for some, infections are one possibility. Then there is the need for a porta-cath type of device which is used to refill the pump by injection. That device also carries the risk of infection or clogging.
In any case, I sincerely hope everyone finds a treatment option that works well for them.
Larry
I have been searching for information on fentanyl 12 since a new pain doctor prescribed them to me. I went there for the burning in my head I get that wakes me up everynight for the last 9 years. Plus now I have neck pain and back pain due to degenerative disc disease and firbramyaliga. I had been taking tramdol for years only in the middle of the night and sometimes during the morning hours. However my head pain could at times last longer and for days with no relief from tramdol or hryodrocodone 5. My IBS does not sit well with the hyrdo. but tramdol I can tolerate using fiber. I am a cancer surviour and lost one lung.
My worries are since I have COPD and one lung how safe will this be for me?
I use a bi-pap at night and 2 liter of oxyen. I don’t like taking 2 types of pain meds, one for my head and neck and the hydro. for my back. Tramdol does not help my back and helps some with all over body pain but does not last long.
I am trying one today since hubby is home with me to see how I do.
Does anyone have any comments?
Hi Pam – how did it go? I was thinking about you and hope that your trial went well.
This med fentanyl sounds interesting, I have a high tollerance from long term use of hydrocodone 10/325 it takes me at least 7 tablets to get my back to stop hurting enough to get out of bed in the morn, but im my DR moved and I was handed to one who visited me in the hospital, he said oh no I can not take you as a patient, I don’t prescribe pain meds, but will care for you while in the hospital, the clinic owned by the hospital has carried me on med but want me to ge a PCP hard to do as most wont take any new Medicare pt’s Im on 2 littre oxygen 24-7 and worry about the hydro withdrawl as I try any thing new, oxy was ok fast but short, whats the best to ask for, I have long term back problems and my arms and legs are diff, from nerofibromitosos, spelling, also have congestive heart failure copd, w’ emphizima and pulmoary fibrosis only been out of the hosp 2 mo’s doing ok but keep haveing to go to hosp for demerol shot, last time the gave me DILADA sorry spelling I added this post to my favorites and you can allways email me, I dont worry about giving it out eugeneabennett@yahoo.com it’s also my name a lot of Dr’s in Arkansas don’t even handle pain mngt’ and some that do want 180.00 a visit and Im on social security, I would even be happy getting off the hydro and going with the large amounts of tylonal and asprin, it dont wok well but the amount of hydro req to keep me out of pain and out of withdrawl is crazy, thank to all of you and best wishes, I know how it hurts to hurt all the time and people look at your crazy when your allways whining,
Hi everyone, hope you are all doing well today.
Eugene, I am also on Medicare with an HMO supplement. I had to see a pain specialist before I could get the duragesic patch (Fentanyl). Then my regular internist could prescribe it each month when I see him. My HMO rules demand it that way, at least in my case and with my HMO. (SCAN HMO). I am now replacing the patch every 48 hours instead of 72 hours plus Norco (hydrocodone 10/325) for breakthrough pain. My withdrawal symptoms are much less severe now than when I was changing every 72 hours. I am using less Norco also. So far so good. I am going to stick to this regimen as long as I can as I don’t want the surgery for the morphine pump until absolutely necessary, (when I had my spine surgery I went into respiratory arrest twice, and I am trying to avoid general anesthesia again if I can help it. As I said so far so good, I will let everyone know if anything changes. Best wishes to all, and I hope you find what you need to ease your pain. God Bless all of you.
Larry
You guys are great how you handle all this, it;s been another up/down weekend, trying hard not to go to the hospitel, the day was made with one oxy 30 and a half of one and 9 hrs later a 10/500 plus 3 asprin and 2 tylonol, ive stayed within the 2000 mg cap on the tylonol trying to save my liver
hey everyone ,read you comments and am sorry to hear of these terrible afflitions you have.my promblem is not so severe, ive been on tramadol for a year and a half for back pain.my doctor just gave me 10 fentanyl patches 25 mcg per hour.this patch is way to strong, however and i dont keep it on for more thn 24 hours.im going t a follow up visit in two weeks ,any suggestions on something a little weaker ,right now im taking about 300 to400 mg of tramadol daily that seems to keep the pain at bay but my doctor doesnt want me taking that much.see you all,i wish you all well
Hi my name is Mark I live in Knoxville TN I am a 49 year old man and I grew up on a farm and I was very active when I was youing I now have Arthritis and they even told me I have Fibromyalgia (forgive my spelling) I have three fusions in my neck c6 c7 &c8 and two in my low back L5&s1 I have had three knee surgries on my left knee both my shoulders have been scraped and several bone spurs were removed from the nerve canals in my neck. For ten years I have been on hydrocodone and a mild muscle relaxer tizanidine 4mg about 5 years ago my doctor who I think is a great doctor put me on the fentanyl patch and I eventually worked up to 100mcg/hr and then I had my final neck fusion surgery. That was in November 07. Well now I am ready to see what happens if I stop wearing this patch. A year ago I went down to 50mcg/hr. I found that it had stoped working on the third day and I was going into withdrawls on the third day and that mad me mad. My doctor told me to wear a another patch on the third ay a 12mcg/hr additional patch to get me through the third day so I did and it helped but that meant I was going back up instead of down. So this month I decided I had enough with these patches and I embarked on a path to get off them. I first went down to just the 50mcg and I had been using the name brand for the last year the generic didn’t stick so I had gotten my insurance to cover the name brand, Back to now after 9 days I went down to a 25 and a 12 every three days. Don’t get me wrong every third day has been tough and still is. After 9 days on the 25 and 12 I went down to just the 25 and for 6 days I wore just the 25 and then yesterday I just put a 12 on. I have to tell you I don’t feel to bad today I guess tonight and tomorrow will be rough but if it’s not to bad I won’t be putting another one on. I have decided I would rather hurt more and take less med’s because my quality of life is hampered by have ing to wear a patch. I have to take them with me and then my life revolved around every three days. I want to live one day at a time not three days at a time. Good luck to you all. Just Remember God is with us!
I have been on a fentanyl patch and norco for some time. My doctor has had me change the patch every 48 hrs.. Except for the fact that it doesn’t stick very well, I get a rash from it. I called the comp (mylan) and they were suppose to send me covers that help them stick better.. but they haven’t…Does anyone out there have any suggestions on keeping the patch on and stopping the rash and itch? I end up having more tape on me than patch. But the medication itself has been a big improvement over other pain meds I have been on.
i also have very sensitive skin and have been using a nose spray flovasc for the irritation. My dr. kindly gives me samples of it, and i rub all over as big as my patch cover(tegaderm)is, which i cut up from larger patches.and make sure i drink plenty of fluid to keep away dry skin.
Now i have a question anyone getting black teeth i did not get my first filling until i was 27 after giving birth to a baby boy which i have heard boys in utero take more of your calcium. now my WHOLE teeth are looking disgusting.
I am back to Tell you about the rest of my experience. I have had the roughest week of my life this week I have suffered from lack of sleep and have devoleped restless leg syndrome I take Hydrocodone and my neck and back pain has been tolorable and has shown me that I didn’t need to be on the patch maybe a little stronger pill of some kind and I am going to my doctor to talk about this tomorrow. So if you are thinking about going off the patch and you have been on it for a long time look for a rough going. Night time is the worst it has been 9 days since I last had a patch on and at night I am still suffering my legs and forearms feel like they have the creepy crawl’ys and I can only sleep about 5 or six hours with out waking. I will get through this I just wanted to share my experience with you to maybe help in some small way.
Hi Connie (and everyone else).
I had the same problem with the patch falling off as you did, and found a simple, cheap solution. I now cover my patch with Band-Aid brand WATERPROOF bandages, just big enough to cover my entire 100mcg patch. Works very well, doesn’t even start to peel at the third day. I also had rashes and sores when I initially started the patches, but it subsided in a few months. Ask your doctor about taking antihistamines, benadryl or something else for the allergic reaction.
Mark, I am curious as to the amount of Fentanyl you were wearing. I know that I will have to use heavy-duty opiates for life (three doctors, including two neurologists have confirmed this) because of the level of pain I deal with. I could live with this and will have to I guess, but the thing that bothers me most about the patchs (besides withdrawal on the second day) is that all of my previously healthy teeth are steadily rotting (had two extracted on Tues last) and the doctors don’t warn of this problem. I had to do a lot of research on my own to find out why my teeth were breaking and falling out of my head. I suggest all who are on the patch to get to a dentist early to find out how best to slow down, if not stop the process.
God bless all of you, and everyone who suffers.
One last thing friends. After my back surgery I found that I had developed neuropathy (sp) pain in my feet that the narcs did nothing for. I tried neurontin and it did nothing.
It was driving me crazy and prevented sleep, because if the softest blanket I own so much as touched my toes, I was waked with very severe pain. I could neither stand nor walk because of it.
I live in a state that allows medical marijuana, and I had read that marijuana can help with nerve caused pain, and symptoms similar to mine.
I asked my internist who sent me to a neurologist who specializes in pain, and flat asked him about whether it (marijuana) might help with my feet, and he said it was worth trying, that other patients had said it helped them with similar complaints.
Bottom line is now I can stand for a minute or two, walk a little and no longer wake in the night from my foot pain. Take it for what it is worth, and perhaps discuss it with your doctor.
L
Thanks for the info – it makes me mad that the drug comp. know there is a problem with it sticking and don’t supply the proper things to make it stick. It’s costly and should work right the first time.. I will try the bandage, and I am glad to hear that the rash will go away in time. I don’t want to have change meds again. As with all of you people on this site I have suffered endlessly with pain for over 2.5 years – and since the patch delivers a steady dose each hour I don’t wake up in the morning bracing myself for the first step out of bed. I hurt but it’s tolerable.. I didn’t know that the patch could cause dental problems.. I thought is was only if you used the oral form.. Thanks for the info ..
When I used the patch I used Silk tape I got it from the local medical suppy store. It worked pretty well.
I am on the 75mcg/hr patch every 3days. I have terrible rashes that are getting worse and worse each time I replace the patch. Also the third day is a living hell. I have oxycodone 10mg for the b/thru pain but I hate taking so much of it on the third day (I can take 1 pill every 4 to 6 hours, but the first 2 days I don’t need them, the third day I need one every 4 hours). I don’t like the patches anymore. I don’t think switching to every 2 days is going to help the rash, the rash starts after about 8 hours after applying a new patch. I cannot shower at all , no matter what cover I wear over the patch, NOTHING sticks well to my soft and sensitive skin. I want to scratch the patch right off, and sometimes do in my sleep which compromises my supply of patches. I have found that I cannot get a replacements for the patches that are wasted by itching them off, or even if they leak due to being inferior. I can only use Generic brands due to my insurance. I really want to go back on methadone, it worked the best for my pain and I only switched because I thought “Yeah, not having to take 3 of the 10mg methadone pills every 8 hours will be GREAT, since they passed the law banning the 40 mg wafers from pharmacies). I would MUCH rather take 3 pills every 8 hours now, they were small and I could swallow 2 at a time, so I want my methadone back. Do you think a Pain MGT doctor would let me go back on methadone? I got the methadone from my primary care then she stopped prescribing narcotics for chronic pain due to having too many pain patients and some that got caught selling their medications, so the DEA asked her to stop (I hate those junkies that ruin it for the rest of us REAL pain sufferers, can’t they just do herion on the street and leave the pain medication to the REAL pain patients!!!). Anyways, most doctors would not make you stay on a medication that is really bothing you side-effect wise would they?
I am on fentanyl patches (Generic Watson) and they are driving me NUTS! Its been 2 months and I HATE THEM! I get terrible burns and boils from the patches, they don’t last 3 days and I’ve been titrated up 3 time so now I’m on 75 mcg/hr every 3 days and still am itching. I even tried Mylan brand and Sandoz brand and they are even WORSE! Sandoz literally burned my skin so bad it peeled. Mylan still gave me an itchy rash, but it they were no where near as strong as Sandoz or Watson and I got sick and was in terrible pain for the 6 day trial. I want Methadone back. I was fine on Methadone. I had to start seeing a pain specialist because my primary care doctor stopped prescribing narcotics to chronic pain patients (she had way too many pain patients for such a small community, and some of them were just addicts or dealers and they were caught and the DEA stepped it), that was the last of her pain practice. I was sent to a great pain mgt doctor, but I’m afraid that he won’t put me back on Methadone. I am always scared that I’ll be stuck out in the cold to deal with withdrawal and severe pain on my own (from experience, I had a clinic stop presribing and let me withdraw with no help because I lost my insurance). I really hope my new pain doctor will realize that I gave it 2 full months and I’m very unhappy. I don’t want to go up to 100 mcg I want oral medication, because I know I won’t get a rash and I don’t have to live my life in fear of the “THIRD DAY WITHDRAWAL AND PAIN” and won’t have to take a 10mg oxycodone every 4 hours to kinda survive even though oxycodone makes me feel sick and dizzy. Does anyone here think my doctor will listen to me and change me to Methadone or something equal (not MS-Contin I get hives from Morphine, and not Oxycontin, I get migraines from that, I was on Oxycontin for about 6 months and didn’t realize it was the cause of about 3 migraines a week, and so I used migraine medication on top of it, but then when I asked my doctor about it, they agreed it was the oxycontin and I was changed to something else). My story is long, and it has not been easy, my family thought I was just “drug seeking” and tried to intervene and tell my doctor that I was only taking medication to “get high”! HA, that’s so far from the truth, I have NEVER felt high from any narcotic medication I’ve taken, the medication worked properly and ONLY helped with my pain! So do you think I’ll be changed back or do you think I’m doomed to be bumped up to 100 mcg or stay at 75 mcg only every 2 days? And be told that my rash will go away, because from experience I know it will only get worse, the pharmacist says it looks bad and I should be taken off of them and put back on oral meds.
Hi all I am new to the fent patch and am on 100 mcg… and vicoden for break through. I was just taking morephine sulfate for about 3 years dose 45 mgs every 8 hrs with breath through meds, I ended up in the hospital with severe adominal pain, found out the morephine was messing with my intestins and pain dr wanted me off morephine because he rather have someone take a patch 3 days then change it rather then taking so many pills plus breathrough meds. I have been in 4 car accidents and I am only 22. I also have spinal bifida, and 2 disks with space narrowing, and severe neck pain which is intrasable why my back and neck hurt so bad. done MRIS everything. the fent patch even at 100 mcg doesnt seem to help my pain and was told this drug is very strong, the morephine never really helped and had to keep going up on it as well. so I really don’t know how long I need to wait for the fent patch to actually work I’ve had it for a week and still feel a 7 out of 10 pain
any suggestions would be great, I am working with a pain management center but they don’t want to make me so drugged I can’t funtion I have 2 kids, since the car accidents Ive been on disablity my job fired me due to not being at work due to the pain so everything is a mess right now, I just wish I could find out how to stop this horrible pain, and where I am not on such a powerful pill. advil gave me ulcers of the stomach so am warned not to take it. I am just lost. I feel sometimes on the 3rd day my pain is its worst, 10/10…. but Im not sure if the fent patch is working for me. maybe I need a diffrent medicine.