For those of you currently using fentanyl patches (usually marked as Duralgesic patches), please read the article in the news section of the OCF web site:

http://www.oralcancerfoundation.org/news/story.asp?newsId=858

The FDA has issued a public health advisory about these patches and is concerned that patients and doctors may not be aware of the potential serious side effects and what to watch out for. It seems that the side effects of the patches can be worsened by exposure to heat, drinking alcohol, taking antifungal druges and so forth.

During my treatment, I was up to 175 mcg. of Fentanyl, the active narcotic in the patches and it was very helpful in setting a baseline of narcotics to control pain so that I could use oxycodeine for breakthrough pain.

The patches are supposed to be slowly absorbed by the body over 72 hours, so you can imagine that anything that speeds up the absorption process is potentially dangerous. - Sheldon

I can only reiterate the potential danger of some types of these "patches". We have a standing order at the Medical Examiner's Office which requires us to seize any patches when we attend any death of a person using duragesic patches. The toxicology lab checks to see if there were any defects in the patches or if the levels in the subjects blood are excessive. This warning has been in existence for some time so I am surprised it is only now being placed in the public domain.

Paul C

After radiation, my mom was on 125 m. of Fentanyl plus 2tsp. hydro codone every 4-6 hrs. She ended up so drugged up, she was unable to walk or toilet herself. She then got pneumonia and was hospitalized. After that in a rehab facility we fought her dr. to reduce the patch and the other pain meds till she "came back to life." The dr. was trying to keep her from feeling any pain, but in the process almost killed her. The rehab facility was so pessimistic, it wasn't till we moved her to another facility that she got out of diapers, regained her ability to walk and went back to living independently. So, be careful of the pain patch or the other pain meds. There can be too much of a good thing. Linda g.

Linda, what a scarey story! Good for you for getting her out of there! Amy

The warning doesn't sound much different than for any other opioid. All of them, especially morphine, can cause the same thing if one OD's or combines it with alcohol or interactions with other drugs. We had a pharmacist here, years ago, commit suicide with Fentanyl patches.

You must understand how the FDA deals with so-called "adverse effects". If they receive ANY adverse effects reports then they require the manufacturer to add it to the adverse effects list in their package labeling. 120 deaths in a drug that sells 2 billion in sales a year is probably a statistically very small number. The adverse effects reporting requirement in the Code of Federal Regulations (see http://frwebgate.access.gpo.gov/cgi...p;SECTION=80&YEAR=2001&TYPE=TEXT to see for yourself just confusing this is - that's why they pay me the big bucks as a regulatory affairs VP -lol) how often leads to contradictory information and many times pratically renders the whole process somewhat useless.

Excerpt from the "Dear Doctor Letter" See http://www.fda.gov/medwatch/SAFETY/2005/duragesic_ddl.pdf for the entire letter:
"The changes reflect FDA

Gary,
I thought that the FDA warning of possible interaction with anti-fungal drugs would be particularly important to oral cancer patients undergoing radiation treatment because of the increased likelihood of thrush and the natural tendency of doctors to prescribe diflucan to deal with it.

I agree with you, a lot of us would have had a very difficult time getting through our treatment without the patch. Committing suicide with these patches, what a strange concept! - Sheldon

Wow, I had no idea. However, I'm kind of glad now that I successfully weaned myself off them. However, I'm also grateful that at my worst, they did help control the pain in going through treatment. Back in those days, I thought they were pretty harmless looking and didn't really notice too much of a difference in how I felt... that was until I forgot to put another one on after taking a shower... then it was "OH MY goodness, I forgot to put on a fresh patch!"

When they upped my dosage to 100's I only tried one 100 patch and noticed that I was getting too loopy for my own good. Maybe I was too much of a lightweight for it, but the strongest I could ever tolerate was the 75. At the end, it was relatively easy for me to jump off the 50.

It's a wise thing to post this information here. I, for one, learned something.

Jen

I don't think that I could have made it without the Duralgesic patches. The highest dose that I got up to was 75. I weaned myself back to 50's and then 25's and then got off completely. I do recall being a little depressed for a few days when I first quit using the patches, but that passed. Like Gary said, all opiate medications can be addictive and/or dangerous if not used properly. That, however, is no reason to take advantage of them if one is in pain and needs them.

Danny G.

Yes it was strange - the guy did it because he killed a couple of patients inadvertently with a compound that he had made which was not done under aseptic conditions. It must have taken some time because these are not fast acting. Maybe he wanted time to think about it first - who knows?!?

I was on a fairly high dose rate of fentanyl and took tons of Diflucan. There are possible drug interactions with almost everything and I think the point here is to be as cognizant as possible of any changes and report them to a docotr immediately. The risk has to be balanced with the benefits so I wouldn't want to scare people off of fentanyl which is one of the best long term opioids for long term pain management.