Friday, June 01, 2012

Duragesic® Trial Ends

By Synergy Tuesday, June 26, 2007

$5.5 Million Awarded to Father Of Fentanyl Pain Patch Victim<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" ?>

 

Last week was the nation's first trial involving a Duragesic pain patch (a form of the narcotic painkiller, fentanyl). A jury in the Federal District Court for the Southern District of Florida, West Palm Beach Division, sided in favor of client, and awarded him $5.5 million for the death of his son.

 

In 1994, the FDA launched an investigation into defective Duragesic pain patches and deaths related to the use of the Duragesic pain patch. Those concerns led the FDA to issue official safety warnings about the use of fentanyl transdermal patches like the Duragesic patch.

 

Duragesic pain patches have been known to leak fentanyl gel. Also, many individuals absorb fentanyl at a higher rate than others. If either of these occurs, injury or death is possible.

 

"We've seen far too many cases like this," stated the attorney. He continued, "For some time, there was compelling evidence of the dangers of this drug, and those signs were ignored by the manufacturers. That indifference ultimately led to the death of this young man, and we can only hope that this verdict sends a message to ALZA Corp. and Janssen Pharmaceutica, the wholly owned subsidiaries of Johnson & Johnson, which manufactures the Duragesic pain patch."

The Answers are in the Details....
6/26/07 8:16pm
It seems to me that patients would be better served if they were monitored for at least some period of time when starting some types of medicines. Too often, it seems like the doctor writes some scripts and off you go, you're not my problem anymore.

Something like this might not go unnoticed if they'd monitor the drug level in the patient at least once in a while. Perhaps we don't have the number of workers necessary to do it, but it sounds so careless not to.


6/27/07 12:19am
The problem with trying to monitor the levels in the blood is that many of us me included absorb it fast and our levels drop fast with in our blood. For some using the patch for its normal 72 hrs is fine but for us that have a high metablizum needs to have it changed every 48hrs. As if I dont I go through horrable withdrawls during that last 24 hrs of the patch and it is not fun.

I saw this a few years ago and that is why it took me 2 years before finally saying yes to using the patch. And the manifacture has made alot of changes since then. And the only thing that will hurt it is if you puncture it, or rip it. The only other thing to watch out for is the way drs perscribe it. This is one drug where you have to start out on the lowest dose possable which is either 12mcg or 25mcg and go up from there dont do the med conversion chart as it might be to much for your body to take and it supress your breathing. And you could just go to sleep and never wake up. When my dr gave me 75s to start I did not do it. I waited and waited and finally I was able to get him to start me out on 25s. Then after my failed surgery I wanted to try to go down so I tried the 12s and went right back up as it was not any better. It is also hard to come off this med as it has a huge with drawl period. You can go cold turkey if you are brave enough but I wouldent wish it on anyone.

Angi
6/27/07 1:44pm

I remember, when this trial started, my neuro wanted me to try it; well, I had to say no for 2 reasons. First, I am allergic to the material the patches are made from, including the plastics and the adhesives, and second, I wuold have had to go without ANY pain meds for nearly a week (think it was actually 5 days...yikes) prior to starting the patch. Then, to top this off, as it was a double-blind study, I could end up with ANY "sized" patch; it could be extremely strong or could have NO narcotic agent in it, whatsoever!


No friggin' way, I said!


This type of trial, for people who've experienced severe pain for multiple years, made absolutely no sense to me; nevermind the allergies! Again, count me as one chick THRILLED she didn't try any of this! And, boy oh boy, did they PUSH for it!


Anne


And, hey, thanks for the update!

6/29/07 6:09pm

I have been on this medication for several years now and have really been lucky - it helps with my pain, and it is way more convenient than taking pills, in my opinion. I agree that doctors should be monitoring patients closely when on any medication that has life threatening side effects. Patients, also, should be aware of any side effects of a medication they are on. Maybe if more doctors took on the responsibility of checking patients blood levels, more deaths could be prevented AND more patients could be adequately treated. Like Angi said, some patients metabolize medications differently and need either a different dosing schedule or a higher dose of the med.
Personally, I think that it is our duty as patients to be informed about our healthcare, including any meds we take. If you learn anything from this lawsuit, please take a look at all the medications you are on and their potential side effects and interactions.
I also wonder, however, what other medications this young man was on. I'm sure that was part of the case but I couldn't find any info in the short search I did.
Anyway, it's too bad that he had to pass away, and I hope the settlement of the lawsuit brings some closure to his parents.
6/29/07 6:10pm
I have been on this medication for several years now and have really been lucky - it helps with my pain, and it is way more convenient than taking pills, in my opinion. I agree that doctors should be monitoring patients closely when on any medication that has life threatening side effects. Patients, also, should be aware of any side effects of a medication they are on. Maybe if more doctors took on the responsibility of checking patients blood levels, more deaths could be prevented AND more patients could be adequately treated. Like Angi said, some patients metabolize medications differently and need either a different dosing schedule or a higher dose of the med.
Personally, I think that it is our duty as patients to be informed about our healthcare, including any meds we take. If you learn anything from this lawsuit, please take a look at all the medications you are on and their potential side effects and interactions.
I also wonder, however, what other medications this young man was on. I'm sure that was part of the case but I couldn't find any info in the short search I did.
Anyway, it's too bad that he had to pass away, and I hope the settlement of the lawsuit brings some closure to his parents.
6/29/07 11:24pm

Hi everyone,


I`m on these patch`s, and have for the last 4 years or so, i`m 100 + 25 ml every 48 hrs, and on top of these i take other pain killers, even with this lot it`s not enough as the pain is that bad, I know that some medication do not suit everyone, even i have some sideaffect`s with these patch`s which is manageable.


 

Barry in the UK.

6/30/07 2:33am
My reason for posting this was to make people aware of the potential problems that could arise from using Duragesic “BRAND” patches… the gel filled ones; which was what this suit was about. There are a few generic brands of fentanyl on the market that use an entirely different delivery system, and from what I have heard… work very well.

There is no doubt there is a need for long acting medication when managing chronic pain, and fentanyl can be a very good choice; but this has spun into talking about apples and oranges here. Yes, everyone metabolizes things differently… but the rate the medication was being metabolized wasn’t the issue. The patch itself was leaking causing the patient to absorb too much medication and resulted in toxic rate of absorption. I’m sure there was other factors involved in this young man’s death, but the manufacturer was held solely accountable… and that alone, in today’s climate, is noteworthy.

We live in a world that in theory has its checks and balances, but when it comes to healthcare/ pharma…. JUSTICE is a very dirty word. There is something inherently wrong with a system, in a democratic society, where the remedy is to blame the victim rather than tell the truth about a situation. I just don’t buy into the quintessential “God” like image that typifies this industry (that doesn’t mean I am litigious either!).

I agree, Stacy, it is our responsibility to understand our condition, treatment plan and what medications we are being given along with their potential side effects/ interactions; which is why I posted this. Don’t just be present; be involved with your care!
7/ 2/07 1:49am

I just wanted to comment on the issue of the brand vs. generic. There are three types of fentanyl patches on the market right now that I am aware of:


Brand
Sandoz Generic
Mylan Generic

The first two (brand and Sandoz generic) are basically the same. They are fentanyl filled gell patches. However, the third one, Mylan generic, are extremely thin (a couple millimeters at most) and are not filled. There is no way for these to leak, per se, however I am sure the delivery system could be faulty in some way.

The bad thing is that I've heard from many patients over the years that are on the patches, and they have found that they Mylan generic patches do not work as well as the brand and Sandoz generic. Personally, I have found this to be true for myself. The gel filled patches just seem to work better. Most pharmacists who have many patients on this medication seem to have heard the same.

Anyway, we definitely all need to be aware of what medications we're on and what the potential side effects and risks are... so this is a good conversation to have for those that are on the patches - if they don't look right, are leaking, etc please call your pharmacy IMMEDIATELY!

7/ 2/07 7:50pm

Hmm.. Hey, guys; did y;all not read the post? Come on! It WAS about the Duragesic (brand-name) fentanyl patches; No matter how much or how little you are on, IF this patch leaks, you are at risk of overdosage, possibly causing DEATH, as was the case with this young man.


Now, I am not going to name names but, you know who you are; to suggest that it's okay to blame the victim in this case, especially after the "victim"/plaintiff WON, makes absolutely no sense. I'm sure that the young man who died relied on his doctor AND, especially, the pharmaceutical company, to make a delivery system which would not kill him. I believe, as is suggested by the win, that the court-system agreed.


Now, Stacy; in your last post, you did have one reasonable thing to say; IF your patch does not look right or appears to be bulging, misshapen, or leaking, DO NOT USE IT!!!


Again, Lisa; THANKS for providing the FACTS in this important case!

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By Synergy— Last Modified: 12/17/10, First Published: 06/26/07