ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Administrative notes and announcements.
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Ghost
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ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by Ghost »

https://www.regulations.gov/docket?D=FDA-2018-P-1846

PLEASE GO COMMENT ON THIS!!! THE TIME FOR IT IS RUNNING OUT!!!

This might be one of our only chances to get the US government to push for stricter warning labels on SSRI and SNRI medications.

"The undersigned submits this petition to request the Commissioner of Food and Drugs to immediately require the addition of boxed warnings, warnings, precautions, and highlights of prescribing information to the product label for all selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) products, including branded and generic formulations.

These include, but are not limited to, citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor), and vortioxetine (Trintellix)."

This is an idea from sufferer Brooks Witzke. A huge thank you to him for working on this. He, Dr. Healy, and others are petitioning the FDA to accept PSSDs existence and demand warnings.

This might be one of the more important regulatory things that we have on our plate. Let's absolutely drown them in comments so we get our voice heard!

Yours truly,

Ghost
Lexapro Sept '14. [Hx] [PSSD Lab] [r/PSSD] [Treatment Plan] - Ur friendly poltergeist
Brooks Esq.
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by Brooks Esq. »

Hey guys, I know I do not get on the forum much anymore. In fact I haven't been on here in like two years. But I would like to encourage each and every one of you to make your voice heard to the FDA and tell your story while you still can. This is a petition to the FDA to recognize the existence of PSSD and require adequate warning labels on the drugs. For any of you on the forum who are also lawyers: this is a portion of administrative law that enables input from the public on proposed regulations to be adopted by the executive branch of government; in this case the FDA.

The pharmaceutical giants have gotten away long enough with masking the harmful effects of SSRIs, and many of your complaints and ailments fall on deaf ears. Many of you deal with physicians who do not believe in PSSD, or the ignorant people in society who claim SSRI's are some of the greatest things to ever be invented.

Now is YOUR chance to make a statement, to submit your comments. If you do not submit your comment now, and the time limit expires, you may never get another opportunity. You can remain completely anonymous, however, being an attorney who is blunt and bold with people, I submitted my letter with my first and last name. You can open the docket folder and read the actual petition and everything it is asking for; it was written by doctors not lawyers so you all should be able to understand it.

As you will already see, big pharma has already had people go on there and submit stupid commentary to downplay the petitions message: "I take zoloft and my sexual function is just fine." I beg all of you, do not let them get away with this, lets load this thing full of comments so they know this condition exists and WE WILL have our voices heard.

God bless all of you, I hope you all will consider my request.

-Brooks
DGS94
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by DGS94 »

Hey,

I've just submitted my comment, pending approval before it will be displayed.
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anacleta
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by anacleta »

we spread the word and comment! (I still have to do it as soon as I have a moment to write well in English). until the comments are open? is the success of the petition based on comments? sorry for the ignorance, I would like clarification, thank you
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anacleta
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by anacleta »

comment send
chemistry
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by chemistry »

Sent mine in
Brief Symptoms:
PE - Anhedonia, less emotions - Test Atrophy - Numb body - Lowered libido = ED
24/7 tension, stress. Worse with lack of sleep, hungry, ill
"Pure-O"
Visual Snow Syndrome + DP/DR + Tinnitus
Insomnia, Fatigue
see intro for more
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Snake
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by Snake »

Is it only for American citizens?
Finding a cure is only a matter of time! Never quit!
fema4psyciatrists
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by fema4psyciatrists »

Remove or disable all your browser extensions first. To make sure the comment gets to them. Says the top of the page.
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lw77
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by lw77 »

But guys i commented and i only see the 3 comments that there where this morning..is that normal?
Brooks Esq.
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Re: ANNOUNCEMENT: FDA Letter (Includes Dr. Healy)

Unread post by Brooks Esq. »

Snake wrote:Is it only for American citizens?
No it is not restricted to American Citizens, any person from any country is welcome to comment. In fact, when the PFS group submitted their petition in spring 2018 many people commented, and a large portion of them were from countries other than the US. The regulatory functions of the United States FDA can effect any person, not just US citizens. Your input is very important despite the country you are from.
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