Fentanyl patch problems lead to second FDA warning

Harvey Kirk

By Harvey Kirk
Posted December 24, 2007


The FDA has issued a second warning about problems associated with the fentanyl pain patch. The powerful drug, which has been on the market since 1990, continues to result in unnecessary overdoses and deaths, especially when it is used inappropriately. Despite an earlier warning issued over two years ago, fentanyl patch problems claim lives and many doctors still do not appreciate the dangers associated with the drug.

>>INFORMATION: Fentanyl patch overdose and death

Fentanyl is a powerful narcotic pain killer. The Duragesic patch and generic fentanyl patche deliver the drug through the skin, and they are only supposed to be used to treat severe, chronic pain by those who are already tolerant of opioid therapy. Although the most common use is by those with cancer, the fentanyl patch is often used for those who are only suffering occasional pain, post-surgical pain, mild pain or headaches.

In July 2005, the FDA issued a warning about the risk of fentanyl patch overdose after receiving reports of at least 120 deaths, primarily by those who either used the drug incorrectly or never should have received the powerful painkiller. Despite the warning, the FDA has continued to receive reports of people dying from overdose after using the patch, and they are now requiring stronger warnings since these deaths likely could have been prevented if the drug had been used correctly.


Fentanyl side effects could lead to potentially fatal respiratory depression. The FDA indicates that the pain patch should only be prescribed to those who take a regular, daily, around-the-clock narcotic pain medication to deal with chronic pain. Those who are not opioid tolerant and only occasionally take these types of drugs, could be at an increased risk of experiencing problems with the patch.

Many of the reported deaths have been associated with users who should not have been given the painkiller and were not fully educated about proper use of the patch. The FDA indicates that some individuals have placed more patches on their skin than they were prescribed, replaced the patches too frequently, put them back on the same spot of the skin or used them under hot conditions. Using the patch while sun bathing, taking a hot bath, using a heating pad, electronic blanket or sauna could cause dangerous amounts of fentanyl to reach the blood, resulting in breathing problems, overdose or death.

Because of the serious risk of overdose, fentanyl patch is not appropriate for those who are using it to manage temporary pain, or on an as-needed basis. It is also not supposed to be used together with cytochrome P450 3A4 inhibitors, such as ketoconazole, erthromycin, negazodone, diliazem or grapefruit juice, which could increase fentanyl plasma concentrations and lead to potentially fatal respiratory depression.

Symptoms of fentanyl patch overdose could include:

  • Difficulty breathing
  • Slow or shallow breaths
  • Slow heart beat
  • Excessive sleepiness
  • Clammy skin
  • Difficulty walking
  • Trouble talking
  • Dizziness
  • Confusion


The lawyers at Saiontz & Kirk, P.A. investigate potential fentanyl patch lawsuits nationwide. Despite reports of deaths associated with the drugs, the manufacturers of the Duragesic patch and generic fentanyl patches continue to fail to take steps which could reduce the risk of injury and ensure that doctors and patients are aware of the risks. To determine if financial compensation may be available, request a fentanyl lawsuit evaluation.

13 Comments • Add Your Comments

  • Vicki says:

    A lot also depends on the brand of patch that is used. Sandoz manufactures the patches with the gel inside of them and I refuse to use them because the fear of having a patch becoming punctured is very probable and, hence, extremely dangerous. As a chronic pain sufferer, I will only use the Mylan brand Fentanyl patches as I feel they are much safer since they have no gel. Thank you for posting the warnings of what overdose symptoms are and the fact that grapefruit juice should not be consumed while using the patch. No one had ever mentioned that to me before and all your info is very useful.

    Posted on March 4, 2012 at 1:07 am

  • Jen says:

    Take extreme caution if you are considering the Fentanyl transdermal system. It is definately effective in reducing pain. In fact it completely eliminated mine. But I began to experience extreme drowsiness on the third day. It was like I had narcolepsy so I had a sleep study done. My doctor said it could not have been from the patch as I did not experience this symptom in the beginning of treatment but I knew it was. I was on the Mylan brand patch at the time. Thank you for posting this list of symptoms and including the grapefruit Juice fact.

    Posted on April 10, 2012 at 1:08 pm

  • Wendy says:

    I’ve been taking the Fentanyl Patch for nearly 3 years. I have never had a problem with the patch or any of the side effects that are listed. I have had numerous back surgeries, and am in pain continuously. Without the patch, I would be in agony 24/7. I have never mis-used the patch or other medications. I follow my doctors instructions and I read and follow the instructions on the package. My doctor is a pain management specialist who requires drug tests upon every office visit. I depend on this drug for my quality of life, which has significantly been altered, and which would be much much worse without it. There are so many quack doctors and pill mills that just write prescriptions for profit, and are really not concerned about their patients. I will continue to be careful, but I will definitely discuss this with my doctor at my next visit. It is important for people to take responsiblity for their health care by talking with their doctors, reading the medical information packages that come with each and ever prescription, and research the side effects prior to taking any medication. With the internet availble to nearly all Americans, there’s really no reason for patients to lack the knowledge about what they’re putting in their bodies.

    Posted on May 29, 2012 at 10:59 pm

  • Wendy says:

    One other important thing to note which has not been mentioned in the article above. Patients who take the transfermal duralgesic should NEVER drink alcohol in any situation. This does not seem to be discussed much on these sites as a contributor to overdoses. The drug tests given by my doctor also include alcohol. I would bet that alcohol plays a big part in the overdoses and deaths. Many people with back pain and other chronic muscular-skeletor pain are also on muscle relaxors, another drug that when taken together is very dangerous. With the patch, there is no opiate high, so many people may try to increase their dosages to reach that high they are used to with pills. It doesn’t work like that.

    Posted on May 29, 2012 at 11:06 pm

  • Brenda says:

    I don’t see any recent posts but thought I would post this about these patches any way. I have been on Fentanyl for some time now. Recently I have been having problems with the Mylan patches but it’s totally the opposite of these problems. There seems to be almost no medication in the patch and you start going through withdrawal right away. I don’t know how to prove it but I know it’s so. This is the second box that has been like this and I just don’t see how this drug company can get away with it. Either some one is screwing up at the plant or they are at the end of the batch. Something needs to be done about this. It’s not fair or humane to make people suffer needlessly especially when they are prescribed a medication to help and paying for it. I think they don’t care because they don’t see how you can prove it. I have kept two of these useless patches just in case another person with the same problem can afford to or knows where to have the patches tested. It’s not right to have to suffer needlessly and not be able to do a thing about it. I can always tell when I have a bad box because within twelve hours my pain goes up so high I can’t get out of bed. With all the hype on pills and people getting high off of anything and everything I’m sure people are afraid to complain for fear of looking like someone having trouble getting high. I don’t get high, drink or abuse anything but when I’m prescribed a drug I expect to get what I’m paying for.

    Posted on August 7, 2013 at 9:24 am

  • george says:

    I also have been on fentanyl patches for some time.i have frequent urinary urges,when i told my doctor she told me to see an urologist which i did ,guess what after multiply tests he did not have an answer,now i believe its the patches which my treating doctor did not know or did not want me to know.i an also having withdraw symtoms even though i take my medicine religiously .my brand of fentanyl is also made by mylan mabye brenda has somthing right aboht defective patches,this is no joke these withdraw symtoms make you feel like dying.ive seen doctors about this and they have no answers for me.it makes me feel as if they dont believe me,no help for me i also lost about 30lbs

    Posted on May 14, 2014 at 5:40 pm

  • c.j. says:

    i had a back injury 15 yrs ago.i was out of work 5 years and was put on all kinds of pain meds.i was also told i would eventually be in a wheel chair,and back surgery was what was needed. i found that the 40 mg oxycontin, loricet break through pain,and valium for spasms worked best.fortunatly i pushed myself through physical therapy and found out i could manage my pain.i eventually stopped all meds and my life began to have hope once again.now 15 years later the pain came back and was worse then before.but this time,this new pain specialist gave me fentanyl.at first it seemed to work well.but now i swear they have too much or too little.the first 24 hrs its a bit uncomfortable,a lit too strong.but it wipes my pain out.wich im grateful.but the last24 hrs.i feel like its coming out quick and i feel horrible.now im having trouble breathing and all the other side affects people talk about.i want to tell my doctor,but im afraid he will cut me off completely.he didnt seem open to the idea of my old med.i dont know what to do.

    Posted on May 26, 2014 at 3:02 am

  • yvonne says:

    Hello. I am currently trying to wean myself off of Fentanyl patches. I’ve been on them several times, this time for almost three years. They work wonders for my multiples pain conditions. Almost a year ago I began having panic attacks that devastated my life and the lives of my family. They started for apparently no reason and within nine months I lost 140 lbs due to anxiety, panic and the resulting eating/stomach issues involved. I had to move and leave my 80 yr old dad that I was caring for because he couldn’t deal with what was happening. I also didn’t want to distress him. I moved closer to my sons. I couldn’t eat. Had to wear adult diapers. Couldn’t drive myself anywhere without panicking. I’ve since lost nearly 200 lbs. I cannot afford to lose more.
    I began seeing psychiatrist that diagnosed me with panic disorder and gave me low dose xanax. Over long months I slowly became better, but in this new city, all the pain drs wanted to keep increasing my pain meds. To the point off being upset that I wanted to decrease them. One wanted me on methadone. I refused. She punished me for refusing by discontinuing my patch and prescribing me methadone.
    Well, I had no choice but to take it when 12 hrs after my patch was removed I was in full blown withdrawals. What was my worst withdrawal symptom? PANIC ATTACKS! thankfully I had patches galore from my previous Dr which I made last until I finally found a Dr that would help me wean.HHe’s weaning me slowly, he gave my hydrocodone back for controlling panic with my xanax. I now know that all along my panic attacks were from patches not working and when wearing off. In two months I’ve decreased from 75 MCCs every 48 hrs to 25 every 72 hrs. I just ended a massive panic attack because I didn’t realize not only did I meet my goal of waiting 72 hrs, I exceeded it by two hours.
    I don’t know what I’ll do for pain control without it. I’m bedridden and in agony with no pain medications, but these panic attacks nearly killed me. I now have an eating disorder. I have a long way to go. Still not stabilized at 25 McGee and getting to 12 McGee to less, then none? I don’t know. What I do know is I can’t continue this way.

    Posted on June 13, 2014 at 1:45 am

  • melanie says:

    my mother and aunt are both on the patches. they were full functioning adults before being put on the patched for pain and now they both fall asleep on the toilet or slumped over. they have sever memory loss. they have bowel movements all over themselves. my mothers doctor said he knows whats best and pretty much told me i was stupid. im watching my family fall apart due to this medicine.

    Posted on September 18, 2014 at 9:18 pm

  • brian says:

    holy cow! I feel so much better for the past couple of boxes of patches I have noticed the same thing that some of you have mentioned. I would feel extremely high after putting the patch on like he was putting too much in my system for part of the first day then by the second day I started having withdrawal feelings anxiety pupils dilated and the sweats! I thought I was going crazy! I am so glad to see that other people are experiencing the same thing. I mean I am NOT glad for you going through this but I am glad that I am NOT the only one. I don’t know should I contact the pharmacist and ask them if they have had people report the same thing?

    Posted on December 21, 2014 at 2:13 pm

  • chris says:

    The watson patch last only 24 hours .I called the manufaturer and they said they know about this problem and have sent advisorys to Dr.s but they are gods so until somebody goes into withdrawls and die and then sues Actavis nothing will change !!!!

    Posted on May 11, 2015 at 6:57 pm

  • Kevin says:

    I am so glad I found this sight. I have been on these patches for 3 years. I guess I am lucky to only have two reactions. The first a year ago and the second yesterday. The first requires a trip to the ER they gave me Ativan. The ER doctor kept asking me if issued up my meds. I knew I did it right. Last night the withdrawal symptoms started. It was about 12 hours on this patch. I am told to change it every 48 hours. I replaced the patch. Within 3 hours the symptoms stopped. My wife told me not to put it back in the same spot. The above comments have been very helpful. I am thinking about going to a pain pump. My doctor suggested it. It seems like a win win. 1/300 of the dose and it does not go through my stomach, liver and kidneys. Thank- you

    Posted on October 22, 2015 at 8:58 am

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