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Old 03-11-2008, 06:19 PM #1
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Default Pain Killer Skin Patch Gets Second FDA Safety Warning

Dr. John informed me that its a violation of copywrite laws to copy and paste entire articles. What follows is a summary, and link to the article. The article includes detailed directions and cautions for use of fentanyl patches.
Quote:
22 Dec 2007

The Fentanyl transdermal system, a skin patch that provides powerful pain relief is the source of a second safety warning by the Food and Drug Administration (FDA). The first warning was issued in 2005, explaining that the product label directions and patient package insert should be followed precisely in order to prevent overdosing - the warning was sent to health care professionals.
Despite the 2005 warning, there have been deaths and life-threatening side effects occurring. Usually, patients incorrectly used the patch, or doctors inappropriately prescribed it.

The entire article is at http://www.medicalnewstoday.com/articles/92617.php

You can sign up for Medical News Today at http://www.medicalnewstoday.com/newsletters.php .
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Old 03-12-2008, 11:46 PM #2
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I have been using the Fentanyl Patch for over 6 years without incident. It is a superior pain reliever. I understand the proper use of this medication and there is nothing to fear provided it is use properly. All medications can be very harmful and even deadly if not used properly...people can die from abusing aspirin.
Work with your doctor, read the instructions that come with your medications, and never ever abuse any medication.
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Old 03-13-2008, 07:20 AM #3
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Dan,

I agree. I just had a LONG talk with my PM about this patch. Awhile back he prescribed the 12 mcg patch; not the usual 25 mcg. But I was afraid of it so it sits in my fridge. But he went through the whole thing with me again the other day and I will probably try it in another a month or so. The only reason I am holding off for now is because I have 3 more doctor appointments and there may be some changes to one of my meds. Long story; but I will also be getting a coccyx injection in another week. So, I want to see if any of these changes helps with the other kind of pain simply because I just might not need the patch.
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Old 03-13-2008, 08:01 AM #4
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Lightbulb the major problem with this patch

is not the patient need.

It is a problem because DOCTORS are prescribing this patch carelessly, to
opiate naive patients and improper counseling/screening of patients before use.

Sending doctors letters, warning of improper use of drugs has shown to
be a poor way to correct a problem.
Doctors ignored the letters on Propulsid (leading to its withdrawal from the market), they ignore the warnings on Topamax, and these are just two recent examples.

One can visit the FDA and read pages and pages of letters sent to doctors.
I have a link to that site in the Medications sticky here.

I personally am concerned about the poor manufacturing practices of the plants making these patches. The recalls all revolve around poorly made product. Patch technology is very fragile and complex. The more patches become commonly used, the numbers of people increase and statistical variance then becomes acute. It just so happens with fentanyl, that tiny
changes in the patch or ANY improper use, may dump the drug into the
body quickly resulting in a negative outcome. Fentanyl is very potent, and has a narrow margin of safety.
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Old 03-13-2008, 09:21 AM #5
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I'm still trying to get over the fact that you are supposed to keep this patch in the fridge!!!

When Alan was on the patch (long long time ago), I never kept it in the fridge. Never knew you were supposed to keep these in the fridge.

No one told me.

Good Lord.

Thankfully, it did what it was supposed to do at that time.
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Old 03-13-2008, 10:58 AM #6
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Lightbulb like many drugs...

suggestions for storage for Duragesic is below 77 degrees F.

They are NOT kept in the refrigerator in drugstores, hospitals, etc.
They are NOT shipped refrigerated.

Most drugs have storage suggestions in that temperature range. Some say
85 degrees or lower.

There is no recommendation on the manufacturer's data for refrigeration.
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"Thanks for this!" says:
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Old 03-13-2008, 07:17 PM #7
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Melody,

I was told by two different pharmacists to store them in the fridge and then let them warm up to room temp. I don't think you HAVE to; it was just advised that I do. I am not sure why; it is just what they said.
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Old 03-13-2008, 08:20 PM #8
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Wow, isn't it fascinating how different people are told completely different things by the pharmacy.

One would think that there would be a certain rule that has to be followed. But as you indicated, you were told something completely different.

I wonder why???
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Old 03-13-2008, 11:44 PM #9
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I have never stored my Duragesic Patches or the generic Fentanyl Transdermal Patches in the fridge...and they have all worked just fine and I now have over 6 years experience using these patches. I do avoid heating pads, too long in a warm shower/bath, etc which is covered in the accompanying instructions. Absolutely nothing else my docs have prescribed, including Lyrica, have come anywhere close to controlling my constant 7 to 9.5 pain levels. These patches have reduced that pain to a 2-4 level which I have learned over the years to virtually ignore.

The patches don't always work for everyone but they have been a lifesaver for me. I sufferred horrific pain for the first 14 years I had PN and as I look back on all those years I honestly don't know how I made it. All of you who have this level of pain understand what I'm saying and I sincerely hope you have found a doc that will work with you and that you have also found significant relief. Untreated and undertreated pain is a national disgrace and there is just no excuse for this. I pray that in the years ahead this tragedy will be eliminated.
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Last edited by DanP; 03-13-2008 at 11:48 PM. Reason: Grammar
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Old 03-14-2008, 08:07 AM #10
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Frown

The patch is not recommended for those accustom to heavy sweating
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