2/13/08 Approximately one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves. The U.S. Food and Drug Administration and drug maker Actavis Inc. are working to get the word out, but they are targeting retailers and wholesalers, not consumers.
Actavis voluntarily took this step after lab tests showed the active ingredient in one batch of patches produced in Grand Rapids, Mich., by Corium International was releasing medication into the bloodstream too quickly. As a precaution, the company is recalling 17 other lots, too.
Actavis’ Fentanyl Transdermal System patches are individually wrapped and come five to a box. One lot equals 12,000 boxes.
“Actavis is conducting a voluntary recall to the wholesale and retail level only of 18 lots of 25 mcg/hour Fentanyl Transdermal System. Patients who use this product are not being asked to take any action,” says a company representative.
Fentanyl patches are a popular type of treatment for people suffering from moderate to severe chronic pain – such as people with cancer or some forms of arthritis. They release a steady and controlled stream of the opiod fentanyl through the skin. An accelerated release of the medication could cause a variety of problems for patients including breathing and respiratory issues and increased sedation, but the company says it’s unaware of any injuries associated with this issue.
The patches included in the recall have expiration dates ranging from December 2011 to April 2012. The company says while wholesalers and retailers need to return all of the recalled product they have in stock, consumers should continue to use their fentanyl patches as instructed.
The American Pain Foundation doesn’t like that message. The group has sent out its own alert to more than 100,000 people out of concern that the recall was not directed at patients. The group is urging Actavis to extend the recall to consumers.
“What’s odd about this one is there was a recall from the pharmacists’ shelf but not from the medicine cabinet. You tell me the logic of that,” says Will Rowe, chief executive officer of the American Pain Foundation. “If it’s bad enough to take off the pharmacists' shelf, why isn’t it bad enough to take out of the medicine cabinet?
“Our message [is]: Take it out of your medicine cabinet and don’t use it,” Rowe continues. “Alert your physician you have one of these lot numbers so you can replenish the medicine and contact the company saying you want a refund or you want it replaced – which I think the company should have done in the first place.”
If you have any problems with this patch, Actavis says you should call your doctor or 9-1-1.
The FDA encourages patients to report adverse events or side effects from this drug to its MedWatch Safety Information and Adverse Event Reporting Program.
You can check the lot number on the bottom of the box or on each individual patch package to see if it’s included in the recall and you can find a list of the effected lots at the company’s website.
Hello all! I wanted to point out to Marti, or anyone else that has been misinformed about the patch. I myself was on them for several years as well, therefore I'm speaking from experience. You stated that no Dr will prescribe 100mcg to a new patient, but that's incorrect! That was MY starting dose, but soon learned that like many, it didn't last 72 hours and would start withdrawal around 40-48 hours. 100mcg was not nearly enough for my pain! Before I knew it, I was at 250mcg every 48 hours, as well as taking oxycontin, morphine and soma. I have a very high pain tolerance, as well as a high tolerance for medications! I DO NOT recommend people to combine these medications! They were prescribed by my pain management Dr, and NEVER abused! That wouldn't do me much good (or anyone for that matter) to abuse them because then your body will only need more! I had my spinal cord displaced by a first time in my life visit to a chiropractor! This was 10 years ago, and now I suffer with fibromyalgia, spinal stenosis, arthritis, spodelosis, disc degenerating, impinged nerves and herniations at every level. After the spinal cord displacement, I had major back surgery because the neurosurgeon told me if I didn't have it, I would spend the test of my life in a wheelchair from paralysis! At the age of 30 with 2 small daughters, I went against my gut feeling and had surgery 9 months later. I was in excruciating pain afterwards, and it didn't go away! Forwarding on two and a half years later, it was confirmed that they done the wrong surgery! Not only was it wrong, but they had let a student assist in the surgery after I refused it, and even signed a paper refusing the distance of a student! When reading my surgical report, I found his signature on the report as the "assistant"! Now I know I'm NOT the only one who suffers from back pain, but if a person is in "true pain" they're going to take the meds to help get their life back! I'm no longer on the patches because of an insurance issue, but out was replaced with morphine, 2,380mg a day, oxycontin, opana and neurontin. Please do NOT insult me by calling me a liar about the morphine dose! Yes, that is correct and NO typo! I have since lowered the dose to 500mg. I have had many different Dr's at hospitals shake their heads when they heard the dose of morphine, but after calls to my Dr to confirm it, they were in amazement that I could function, and function to the point they couldn't tell I was on anything! It is alarming to be on that high of a dose, but obviously there's a reason it took that amount to work! I went to my Dr asking for him to start weaning me off of it, and that's why I'm at the dose I'm at today! I have tried numerous medications, but no luck! This combination actually works for me, so we're not messing with it since I'll be on it for the rest of my life! I did do a pump trial, but they had me st the highest dose, but still NO relief! They then had it mixed with a blood pressure medication and I had NO pain with that mixture, but it almost killed me because of my pulse dropping rapidly! When I went to the follow up appointment, the Dr said had she known how much damage I have, she would've never agreed to install the pump! Recent films would've showed her (surgeon) that, but she didn't order ANY scans! Please, if you go for a pump, make sure they have new scans done first! I went thru a 5 day trial for nothing! One last thing, I've read from many having a problem with the patches sticking, but make sure you clean the area with rubbing alcohol first and let it dry completely! I've also read about where many have put them so the clothes will help hold then in place, BUT....they are suppose to be worn on the upper body, such as chest, upper arms, shoulders, etc. You will NOT get full effect if worn on the abdomen, legs, buttocks, lower back, etc. Please DO NOT use them with heat of ANY kind, including a hot shower, sauna, heating pad and so on! Caution should be used while using fentanyl! I have a cousin whom passed away from these, but he was an abuser also. Just like other pain meds, or meds in general, too much and it'll harm you, or kill you! I hope you will have pain relief and peace within!
thanks all sherry
If you are concerned about a drug such as Suboxone, please ask your doctor or Google it on the Web. Good sources of drug information include http://en.wikipedia.org and www.drugs.com. When I Googled Suboxone, I got dozens of references, with the most reliable ones on the first page. If you have a computer, you no longer need to be worried about what something is--just Google it.
Read the instructions that comes with the patch. Use no alcohol. It can open your pores to where your body will suck a lot of Fentanyl out of that patch at once. You might like the high but it is dangerous. Ask you dr or Rx.
I have been on Fentanyl for 5 years along with other meds. I am at 100mcg for the last 2 years. I have surgery damage to spinal cord, RA, OA, Fibro, C-spine fusions, etc.
I have other meds as well. I have since decided to slowly ween myself off most of the pain meds and I do not feel any different. I also tried removing the patch since the doc would not let me go back down.
Yep, the first week is a hell you never want. I went back on the 100's and now slowly going down to 75. I don't want to send my life worrying if I will have insurance later on to continue paying for these meds and docs. If my insurance stopped today, I would be slightly screwed. Either way, I have wasted enough of my years on the meds and feeding the pharmacies. I may have pain, but at least I will have a brain.
Lidoderm is NOT narcotic; it numbs spasms, and nerves. Always put your patch above your waist, that way it gets into your system more evenly and try to keep it on the right half of your body. Good luck to all and may you be mostly pain free.
I eventually went to a new pain management Doc who said, "You're on more Fentanyl than my dying cancer patients!" and immediately prescribed me 10mg METHADONE pills 4x's daily and also, began to ween me off the patches and the hydrocodon pills,which only took a week without any negative effects. Also, there's days I only take one Methadone pill and it works all day.
Initially, I was scared of the switch because the patches helped my pain greatly. But today,2 years later, I am so glad she did cause I be honest I was not myself on those other medications. I am so much clearer today and I KNOW what I'm putting in my body.
I WISH YOU ALL PEACE WITHIN.
Important that all people be sure ot dispose of these carefully and keep new ones out of reach.
Babs
I'm quite sure that no one who has posted here has started using Fentanyl at 100mcg doses. I doubt if there are any doctors out who are starting patients at more than 25mcg...maybe a few at 50. Also, my best friend,(who now has a pain pump) was previously perscribed-by her doctor-250mcg/72hrs. So I don't doubt for a moment that someone else was perscribed-by their doctor-to use 3 100mcg patches every 72 hours. Many of us here deal with high levels of pain-as you expressed in your post that you do. I'm confident that the patient who earlier stated that they were using 300mcg was doing so on the advise and with the perscription by their doctor.
I've read all the previous comments. There are sooo many kinds of tape that work very well, you can find something that will work at most any Pharmacy, med. supply store, grocery store, Wal-Mart, K-Mart you name it.
I'd advise more time to set the glue; 45-60 seconds is better especially for those with colder hands. Also, odd as it may sound, it seems to work best,(at least for me) to apply your patch to your butt. Your underwear will keep the patch on. But if go swimming you will want to use a good tape then.
I assume they didn't advise the patients getting rid of their patches because if they did they wouldn't have ANY pain relief until they can get something to replace the relief they got from the patches.
We are LUCKY the Fentanyl patches were invented in the 1st place. The level of pain each of us deals with defines how lucky we know we are. I'm surprised that so many people are complaining so much about such minor issues. If the patches seem like that much of an inconvenience then perhaps many of these people don't need them after all.
The person who said they used it for surgery and acute pain, that was wrong of your Dr. if that is what they did. fentanyl is for chroic pai, it is stated all over the ifo. It is not to be used for acute or fast acting pain and not for surgery or procedures. I know this was long and I am sorry but there are so many issues here. Fentanyl patchs are a God send for those who need them and thank God again that they do not mess with your mind. The craze now for drug addicts are to cut the patches up and to chew small pieces at a time. If you are ot i pai they will cause side effects with thought processing and such. for some one really i pain they do not cause a euphoric state or any such state. An over dose will cause tiredness, slow respirations and can lead to a coma so you need to be alert to monitori g how you feel. everyone should have a schedule of contacting someone every so often just to help monitor it's effects. Take care to all and wishing and praying for the best for all Marti
My doctors were happy that I got off the drug, but stressed that the process could have been a lot easier.
thanks all bobby
I have been on the Fentanyl patches for about 6 years now. its such a huge relief not to be in constant chronic lower back pain 24/7. the patches provide me with such relief,but I still do experience some break thru pain. (it all depends on the activity I'm doing) Anyways Suzie (and Others) I had alot of trouble getting my patches to stick or stay stuck to my skin,I tried everything. Then I came across a fantastic "absolutely" waterproof tape.The tape is made by Nexcare,its sort of like a rubbery type,stretchable tape and its a little darker than the color of your skin. BUT,when you go to change your next patch,take 2 cotton balls soaked with rubbing alcohol and cleanse the area of your skin where your going to put your patch.Let the area dry then apply your patch & apply pressure onto the patch for maybe like 30 seconds.I can almost guarantee that your patch will not peel away from your skin UNTIL you remove it yourself.If you are worried that it might peel away from your skin,then put some of that "Nexcare" waterproof tape on it to hold it in its place.(but make sure you clean a wide enough area of your skin with the rubbing alcohol so that the tape adheres to your skin great.Try my idea first though and apply just the patch,no tape..you'll be amazed. Cleaning the area of your skin quite well with rubbing alcohol REMOVES any & all embedded dirt & especially your skin oils.Its the oils in your skin that affects how well the patch adheres to you.So by removing any dirt & excess skin oils,your Fentanyl patch will stick to your skin with no peeling problems what-so-ever.BUT "IF" you want the assurance that your patch will not detach at all from your skin,that is where the "Nexcare" waterproof tape comes in. I've also read that many of you people change your patch every 48 hours,I myself have to change patches every 48 hrs.NO "2" people in the world have identical metabolism rates,and it is our metabolic rate that affects how the Fentanyl patch works for each & every one of us.
Well Suzie, (and everyone else) I really do hope this info "tidbit" works for you"
Suzie if there is anything else,anything at all,even if its just a question,please don't hesitate at all to get in touch with me and ASK.
If I can help any one of you,I'm so happy to do so.
Take Care ALL!
Joyce
THANKS FOR all the info...from TN>>
Hang in ther you are not alone.
Give your Dr. this information. I promise you they are as thin as a layer of skin and holds for as long as you leave it on. Also I Fentenyl disapates from your system almost as quick as you remove patch. Ask your Dr. I thought I was over dosing but when I got to hospital they discovered I had cut way back on my Xanex and I was havig Xanex withdrawls. They gave me a bit more than my normal dose and I walked right out of the hospital of course it took a bit to get in my system then I left hospital. Please pay attention to your medications, there are many that you just cant stop cold turkey. Hope this helps even 1 person, I will be happy.
I place patch on chest area using a different side every 2 days and it must also be clean shaven and taped.
The first night of patch I have trouble sleeping,almost makes me a little hyper by the 2nd night I can sleep well.
hope this helps someone
They used this to sedate me while they implanted a heart monitor in my chest. I Hyperventilated, threw up, hallucinated and had a nervous breakdown from the stress right on the table! I felt all the pain of the procedure also!
Dont take this drug, or in my opinion ANY Drug they give you! Ive had better luck with essential oils for pain and healing of all my ailments!
Sorry this got long. I hope my tips have helped someone!!
I was on the patch by Sandoz for quite a while when I got a puppy and tried to take it out at night. I got halfway around our Cul-de-sac, said to a neighbor that I couldn't wake up and passed out on the street. He had gone into his house. It was about 3 am. My puppy raised such a stink that he woke up the neighbors, one being a nurse. He called 911 and they woke up my husband. I woke up in the ER. That was enough for me.
I changed Pain Clinics and now I am on Oxycontin but only if I can't tolerate the pain. I hae had both feet operated on as well as both knees (the right one done 3 x.),my left hip, my cervical spine, my back twice (now with a cage), and my hands are getting so bad that I can hardly write and can't stir a pot of stew or use a fork or knife very well. I wish someone would come up with something I could take to help the pain without narcotics. I am very careful because I don't want to add addiction to my list of problems. Bextra was very helpful until they took it off the market. None of the others help. god bless all of you that are suffering. Try to keep a positive attitude and don't give up.
I was just providing a suggestion to people with chronic pain, of what has worked for me...I understand chronic pain, very much...
Here I was having so many problems with my Patches working one time and then putting me into withdrawals the next.
--- Consistent was something my Patches were not. ---
I then went and transfered all my years of records to a new Pain Clinic Dr. because I thought that my 1st Pain Dr. of 14 years just didn't know how to help me any more.
This New Dr. offered me two options because I wanted to get off of as many narcotics as possible.
1. a Spinal Cord Stimulator
2. an Intrathecal Pain Pump.
I chose to go first with the Stimulator because it had nothing to do with Narcotics and was much like using a TENS UNIT. It works Great! But I still have that Lumbar and Sciatic pain that just won't go away. So after 1 year I opted to also get the Pain Pump put in. Now with the Pain Pump I find myself getting nauseous right after each months refill. I lasts pretty much as much as up to 48hrs before I start feeling better.
I am much happier using the Intrathecal Pain Pump Method and Spinal Cord Stimulator in succession than trying to only use the Patches with my Tens Unit. It is so much more successful in Pain Management.
and I have hard time beaning down? Can you help me I am 55 year old and sometime I have a good or a bad day back pain and arthritis pn my life hand thank you PS when you email me back please put attention Ruth pacth
I suffer from chronic pain from Lupus and Ankylosing Spondylitits and I have found the Lidoderm patch helps to take the edge off of my pain...it is not a narcotic..just wanted to throw that information out to you guys, who may want to give it a try if you can not use the fentanyl patch. I was very skeptical at first, but I use them all the time now.
in conjuction with timed release oxycontin--
the various differences in generic manufacturers, made it impossible to know when it was too much--but, as has been noted, if you remove it--it throws off the count until yor insurance allows the next refill.
- I completely de-toxed off both my patchs (had to wear 2-(1-25mg &1- 12mg)and oxycontin-after having these meds for 9 yrs-it was horrible!...andI can't do much pphysical activity--but at least I'm no longer scared of OD...
I've been off the patches now for 3 years..Thank God and pray for all of you who are on them now.
Thank you
I'm very sick now, and may die!!!!!!!!!
An Angry Patient!!!!
I knew I wasn't going CRAZY when I was telling my pain mgt. Doc that my 'patches were wearing out too quickly' . I, too, was on 100 mcg patches ( 3 patches q 72 hrs). Lucky for me, he thought I was just needing to go down in dosing time, so i went to every 48 hrs. And the brand I was on was Mylan. So I go to the 48 hrs and I had a couple of times when I was barely making my 48 hr mark and then all of a sudden things miraculously were better and I was actually able to extend back to the 72 hour mark. Now that a LOT of pharmacies are no longer carrying Mylan brand( I've been told that they are way more expensive than the others) I now use Sandoz brand. I have to use a small sized patch because of my Psoriasis, it's not easy finding room on my legs if I'm broke out for 3 patches!
Thank God for this notice AND SHAME ON THE FDA FOR NOT MAKING THIS PUBLIC KNOWLEDGE. God knows it's BAD ENOUGH for us to be in CHRONIC PAIN, but then to make us feel like LOONEY TUNES because we are running out of medication. It's made me always make sure I fill my prescriptions a few days earlier( I can't fill earlier than a week due to my insurance) just to make sure if I have this happen again I won't have to bother my doctor. And i sometimes go 72 hrs instead of 48, but that usually happens because I've forgotten when I placed them !!
Wow, I'm really letting folks know about my lousy memory!! Thanks AT for this forum, to think I stumbled across this cause I was looking up about RA for my hubs.
Another woman here had the same OD problem with the Fentanyl patch. I cannot believe we are the only two. I will never use another patch of any kind as it is just too dangerous. Had I not recognized the signs of an overdose and hadn't taken the patch off immediately, I could have been in very serious trouble.
Thank you for this forum to let others know about these problems. Karen
Thanks so much for the information.
Paul
Leave a Comment