SOS: FDA CONSIDERING REMOVAL OF HIGH DOSE OPIOIDS – this one is DIRE for ANYONE utilizing opioids.

LAST DAY TO MAKE COMMENT

 

SOS: FDA CONSIDERING REMOVAL OF HIGH DOSE OPIOIDS – this one is DIRE for ANYONE utilizing opioids.

USE THIS LINK  https://www.regulations.gov/document?D=FDA-2017-P-5396-0001

PLEASE SHARE/Copy&Paste encouraged/please ask admins first before posting in other groups/FDA deadline Weds. 2/28/18

Andrew Kolodny and PROP has submitted a petition to the FDA that could threaten to limit your access to high dose opioid medications, regardless of your doctor’s prescriptions or your medical needs. The FDA is considering this petition which would remove ultra high dose (UDHU) opioids from the market. This is a very, very serious issue and 100% participation is needed before Wednesday, February 28th, 2018, to stop this from happening. The FDA already removed Opana ER, lets not let this happen to a medication YOU or your loved ones might need. Please remember, the FDA will toss if comments appear similar, so use this as a guide.

From: Valorie Hawk/Director/C-50/Coalition of 50 State Pain Advocacy Groups -Please join your state advocacy group and work alongside your neighbors at your state and local level. https://www.facebook.com/Coalition-of-State-Pain-Advocacy-…/

FDA RESPONSE

1.Check out the petition to the FDA here: http://www.supportprop.org/wp- content/uploads/2014/12/ Citizen-Petition-UHDU-Opioids- 8.30.17-final-signatures-2.pdf

2.Go to https://www.regulations.gov/ comment?D=FDA-2017-P-5396-0065 to comment

3. In the large text box, enter your comments about WHY you oppose this petition and why the FDA should as well. These are some points you could make. Please tailor them to your own situation – if you copy these exactly the FDA will NOT consider them.

A. I am a chronic pain patient with ___________ (diagnosis)

B. I rely upon opioid medications to: manage my incurable pain, allow for increased function, preserve my way of life, and remain productive. Please explain how benefits outweigh risks.

If you are taking high dosage or extended release opioids, please discuss how they control your pain better/longer than other options, please be brief, clear and concise – no caps. Things you may want to include:

* benefits outweigh risks, over 95% of legitimate pain patients
do not abuse
* explain how opioid medications help(ed) you and how for
long, especially if they are/were high dosage.
* discuss function – the things you are able to do (work,
chores, travel, enjoy life, sleep) with pain relief and what it is
like (or would be like) without it. Mention if you have had to
leave your job, lost your house, your family, car, etc. Share
if you have had increased BP/pulse or other adverse health
effects if your medications have been reduced/dropped.
* discuss the non-opioid medications you have tried (and
adverse reactions) –
* explain you do not get high/euphoria
* discuss all of the treatments you have tried – for example –
PT, OT, Aqua T, Chiropractic, Osteopathic, TENs, MENs,
mindfulness, yoga, CBT therapy, biofeedback, acupuncture,
acupressure, CBD, Kratom, etc., and how they failed to
‘heal’ you or lessen your pain.
* explain you have been a model, compliant patient, and if
you have a pain contract (include how often you have UAs,
pill counts, and if you have to use one pharmacy, avoid
alcohol, etc.). Mention that it’s unlikely your condition will
approve, and the effects of time and aging will make things
worse.
* Opioids and pain management were a last resort option.

D. I always secure my medications where they cannot be
stolen, never allow others to borrow and do NOT have
excess medication.

E. These proposed regulations are not supported by any
reliable science.

* the 90 MME cutoff that defines what medications are ultra-
high dose is arbitrary
* everyone genetically metabolizes medications differently
* the CDC guidelines were written outside the rules by non-
pain management physicians, some who may have
professionally or personally profited from the outcome
* none of the petitioners are qualified or Board Certified in pain
management
*cancer patients need these, as well

F. Not everyone can just “swallow more pills” – *some pain
patients have conditions (e.g. nausea, esophageal
spasms) that make swallowing difficult

G. If enacted, these policies could:

* force even more doctors away from treating pain
* force more patients onto Disability, Medicare and Medicaid
* create more demand for emergency room and social
services
* increase the rate of expensive and possibly dangerous
procedures
* increase the rate of suicides
* possibly put many more pills into circulation

3. Fill in the information at the end
4. You may choose to be anonymous or use your name
5. Do not write anything under the category “organization”
6. Choose SUBMIT. If you get a receipt, you have been
successful! It will take a few days to see your comment
posted.

AT LEAST 10,000 COMMENTS ARE NEEDED TO START BEING NOTICED. ASK EVERYONE YOU KNOW TO HELP. SHARE THIS POST EVERYWHERE

4 Responses

  1. I spent a few hours writing my comment and it wouldn’t go through! I’m so infuriated! I contacted the FDA to tell them but I haven’t gotten a response yet. I shouldn’t have answered all of the questions though because I had to spend a lot of time shortening/editing my comment shortly before the deadline. I didn’t realize that there was a character limit. After I shortened my statement, I was still unable to post my comment so that didn’t make a single difference. I checked all of the right boxes and I didn’t have any browser extensions that would prevent me from posting it so I don’t know what the problem was. After all, my comment about the website not working went through!

  2. Please comment today, by tomorrow the FDA site will be really sluggish and you risk your comment going unheard! Use the ‘Individual Consumer’ category to place your comment! Shatterproof is putting a massive call out to respond, we need to see pain patients sharing our side of things.

  3. This is very easy to do! I’ve done these before, it takes all of a few minutes. Please everyone, take the time to do so. They need 10,000 and there are only 880……this is so sad! Please reconsider and take the time to fill this form out and write a brief statement. Its so easy to complete!

    • I was not properly informed about character limit! Had to shorten ltr. Still couldn’t figure out how to post my ltr??
      A lot of us didn’t get posted due to confusion.

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