PSSD Forum

published all the comments!! comment if you have not done it yet!

Ghost wrote: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

I think this post is misleading, I just read this thread and at first I thought that this is a new petition because your post is so misleading. This letter doesn't just "include Dr. Healy", he's the author of the letter (see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004927/ ) (not Witzke) and the idea was from the PFS foundation: https://rxisk.org/enduring-sexual-dysfu ... 300-cases/

By the way, am I right that we can comment until Nov 07?

future-recovery wrote:

Ghost wrote: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

I think this post is misleading, I just read this thread and at first I thought that this is a new petition because your post is so misleading. This letter doesn't just "include Dr. Healy", he's the author of the letter (see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004927/ ) (not Witzke) and the idea was from the PFS foundation: https://rxisk.org/enduring-sexual-dysfu ... 300-cases/

By the way, am I right that we can comment until Nov 07?

I was the one who came up with the idea when taking administrative law. As an assignment each of us was supposed to comment on a petition of proposed rule making on Regulations.gov. I just so happened to find the one PFS foundation did and it was still open for commentary so I submitted a comment for credit. I then sent the link to Dr. Healy and explained to him how he could go about creating something similar for PSSD. He was not aware how to do it as FDA proposals are something we learn in law school. As for me not being on the petition itself, why the hell would I put my name on a medical petition when I do not possess the required credentials to make medical claims with credibility? If you were arrested tomorrow for murder, and you had been framed by someone, who would you want to represent you in court? Your teacher? Your doctor? Your best friend? NO! If you were not guilty and had been framed you would hire the best lawyer you could possibly find. If later you needed major surgery performed, you wouldn't want the lawyer who represented you in court to perform it, even if he was brilliant and got you off the hook. You would want a skilled physician. Here, this is a proposal to re-label an entire class of pharmaceuticals, I do not think you should penalize me for not putting my name on the study when my specialty is elsewhere.

Hey guys, I know many of you were concerned about the comments not being posted on the petition. I just wanted to follow up and let you know that I ended up emailing and getting the FDA Ombudsman Office involved and they made certain every last comment was posted on the site. They are all on there now.

Brooks Esq. wrote:

future-recovery wrote:

Ghost wrote: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

I think this post is misleading, I just read this thread and at first I thought that this is a new petition because your post is so misleading. This letter doesn't just "include Dr. Healy", he's the author of the letter (see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004927/ ) (not Witzke) and the idea was from the PFS foundation: https://rxisk.org/enduring-sexual-dysfu ... 300-cases/

By the way, am I right that we can comment until Nov 07?

I do not think you should penalize me for not putting my name on the study when my specialty is elsewhere.

I didn't say this at all. I just wanted to make clear that Healy is the author of the letter.

If the petition was your idea, I thank you.

Just so you guys know, time is about to run out on this. If any of you want to submit a comment, now is the time.

Submitted. Im new here and I'm very glad that i have discovered this forum. You guys are awesome.

Zolofthater420 wrote:Submitted. Im new here and I'm very glad that i have discovered this forum. You guys are awesome.

Thanks, welcome to our community, although nobody would want to belong here XD

True... Rip
I'm always thinking that I'm invincible against every bad situation after beating this shit and getting out off this hell.

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

Only 2 days left all, then they will stop accepting comments. Click on this link if you want your voice heard, it is very easy to submit a comment.