FDA Fentanyl Warning

[mmglobal]

Interesting email from Dr. Baumbach included a warning about use of Fentanyl transdermal patches. This is an update (posted last month) to a 2005 advisory.

http://www.ispine.org/article-librar...tanyl-fda.html

I'm curious to hear from patch users. Were you told that running a fever of 102 or sunbathing with the patch on can cause dangerous levels of fentanyl to be delivered?

I hope this helps someone.

Mark

[KL Aguilar]

Mark, I don't know much about these patches, but I have Lidoderm patches and they really help. Are these also dangerous? I know I can only use two at a time, and twelve hours on and twelve hours off. I was not told, but would've guessed that using heat with them would be a no-no.

I am now seeing a physiatrist in Fullerton. He is questioning the last two surgeons' recommendation of a two-level fusion instead of something less invasive. (To refresh your memory, I am referring to Dr. Lauryssen and Dr. Samudrala, the latter of Cedar Sinai).

The physiatrist gave me three trigger point injections around the right scapular area and the areas no longer hurt! It still hurts above and below the areas he injected though. Twelve and a half years of being a cervie and this is the first medical professional to recommend trigger point injections...

[martyusa]

Thanks for the update, Mark. I passed this onto my Wifes employer @ the hospital. According to her, they do not prescribe this all that often. But, knowledge is power.

[Poncho]

Hummm....I can't say that when I was on the fentanyl patch that this fever & heat thing was mentioned. Lack of working at low dosages and nausea at higher levels is why I quit taking it.

It makes sense though - perhaps because the heat would make the medication more liquid - like and the skin pores opening up to the heat would make for quicker rate of absorbing the medication. Interesting thread.

[teg]

I was on the patches for a year starting 5 mcg. My frustration with the patches was the fact that the medication did not touch my pain and they did not stay on during the summer.

My doctor never gave me any instructions for using the patch. I put the patch on my upper arm every 72 hours. I am glad to be off the patch now. I also had a reaction to the glue from the patch where I would have red welts.

Anyway, thank you for the information Mark. I think that the Duragesic patch is a good pain management tool. Just like other pain management alternatives, complications may occur and it is good to be informed.

Thelma

[rosedee]

I was prescribed Fentanyl last year by my Pain Specialist. I was not given these warnings. As I increased the dose I developed oedema in both feet, ankles and above. I was told that this was not a known side effect, but he agreed that it did seem to be due to the patches - I had never had oedema before and there was nothing to indicate it was a symptom of any other problem. As I decreased the dose to come of it, the oedema gradually went down. (Despite a slow decrease in dose, I had bad withdrawal). Another doctor I informed about this (orthopaedic surgeon who is reported to be one of the leading ADR surgeons in the UK), just dismissed out of hand the idea that it was related to the Fentanyl.

[mmglobal]

I've been communicating with a client who has such very serious problems that he's on the 75 mcg patch. It was prescribed with little fanfare and no warnings. He did ramp up to 75's or he'd probably be dead now. Not only was his medication prescribed with little fanfare and no warnings, but his insurance requires him to get maintenance medications from sponsored mail-order, so there was no opportunity for a pharmacist to be of assistance here.

He's very severely disabled by pain. Like most of us, he can function around the house on a limited basis and get in his car for doctor appointments and small errands, but he's probably an "18 or 20 hour a day laying down" patient. He's been my client for well over a year. He's somewhat sleep disordered and frequently complains of problems that don't seem spine, but often seem spine syndrome and medication related.... confusion, dizziness, difficulty breathing. Every once in a while I'd hear it first hand over the phone. I know the client very well and I'm not concerned about abuse issues... he's religious about the meds and I've spent a lot of time with him... he's not abusing his meds... intentionally, that is.

It seems that the only thing that gives him relief has to do with hot water. In addition to long, hot showers; he uses his hot tub twice a day.

I cannot stress how dangerous this situation is. Note that his patches did not work very well at the prescribed 3-day interval, so his doctor moved him to 2-day changes. How could it last if he FREQUENTLY accelerated the delivery rate??

At the suggestion of Peter Holzner, the amazingly helpful pharmacist in Bogen, I'm contacting the manufacturer... they should have data on release rates. The client and I reviewed the package insert and it warns of hot tub use. Not only does it not specifically warn about showers, but it says that you can shower with it on. Physical problems with the patches and water can also cause damage the patch (I've seen it), not only making an extra change necessary, but I wonder about the release in a damaged patch?

>> What must it do to all of your systems to get a 'booster' 2-4 times a day?

>> What must it do to the effectiveness of the medication at non-boosted time?

>> What must it do to accelerate tolerance, dependence and addictions issues?

>> What must it do to the risk of confusion related accidents. People who are over medicated not only have accidents and function very poorly because of the confusion and drowsinesses, but they also make mistakes with other medications that can be very dangerous.

I'm sure that this list should be much longer, but I have to go now... I just wanted to get the word out. I'll let you know what I get from the manufacturer.

All the best,

Mark

[Maria]

A friend of mine who is on Methadone was going to attend her son's wedding 5 years ago and she wanted something that offered more pain control for the event.

It was held outdoors in Vegas in the summer. It was extremely hot. Her doctor had prescribed some Fentanyl patches and she had tried them before leaving for the trip/wedding.

She got thru the wedding but became deathly ill upon the car ride back from Vegas and had to be hospitalized for an accidental near lethal overdose due to the supposed increased activation of the patch in the heat.

While she had tried them out here in SoCal, she thought she had regulated herself as necessary for her trip but did not expect the heat to affect her that way. I had mentioned this factor to her before going only because I heard the heat could potentiate the Fentanyl patch quite a bit but she was he** bent on achieving maximum pain relief for the wedding/reception.

Not smart. We need to be careful not only of how other drugs can potentiate our medications but also various factors such as weather, lack of food, water and so forth.

[ans]

Great points and scary too.

Fentanyl was used by the Russians when they stormed the hall where rebels held hostages and lotsa people were killed. Not that this is medically relevant to us.