FDA Petition: Sexual Side Effects of Accutane

A citizens petition to the FDA to add warnings of sexual side effects to the Accutane/Isotretinoin label was recently submitted by Data Based Medicine Americas (RxISK).

https://rxisk.org/petition-about-isotretinoin-sexual-side-effects/

A copy of the petition (containing supportive data from adverse event reporting) can be found here:

Bottom line; Accutane was associated with more reports from children experiencing sexual side effects than any other drug!

Anyone who would like to add a comment supporting the petition may do so here:
https://www.regulations.gov/docket?D=FDA-2018-P-4088

There is no stipulation that a comment must be from someone who suffered, or suffers, sexual side effects, or that they must be a US citizen.

There is a similar petition for PSSD and anonymous comments were accepted and posted. Use “Anonymous” as your first and/or last name if you wish to do so.

If you have persistent sexual dysfunction from Accutane, there is absolutely no excuse to fail to submit a supportive comment!

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You can provide your name and contact information, comment as an individual consumer, and your information will be kept confidential according to the regulations.gov site.

Only one comment has appeared so far and mine is still pending.

What gives?

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I’ve done the comment now, is that all I can do?

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Thank you much. I am planning a protest/rally/public service announcement outside of the FDA HQ for a yet to be determined date to highlight sexual side effects of Accutane. If you could make it, that would be great.

Otherwise, if you have reported your side effects and contributed to the 23andMe data on this site, there is the patient survey coming soon that is meant to clearly define the symptom profile of PAS/PFS/PSSD/etc…

Possible interview opportunities for PAS patients in the near future. We will have to wait and see.

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I ordered 23 and me and I would definitely go… do you see an end at some point dubya?

Yes. The end will come when we have recognition of this condition, a diagnostic tool to identify this condition, and a therapeutic target by which we can treat this condition. There is no reason this can’t be done with biotechnology currently available, or available in the near future. Time and money are the limitations on achieving this.

It sucks that more post-Accutane sufferers aren’t pushing toward these goals. I don’t want to be 60 years old when this moment arrives and know you don’t either.

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I feel like the pfs cure will be the PAS cure as well though, my symptoms are identical… and man I hope you’re right lol, I wanna say within 5 years but hopefully sooner… hopefully in my life at lease lmao

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Couldn’t agree more mate
The systematic problems seem to on the same line.

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14 support comments only on this?

Come on guys - share this around on any forums you go to, and share with any Accutane people you are speaking with.

The comments count as signatures.

To my shame, I have only just posted a comment.

Apologies.

Can everyone who hasn’t commented get on with it, please. 30 seconds is all it takes.

I just wrote down a comment. I hesitated because I am not from the US.

Dr. David Healy and the RxISK team have requested post-Accutane patients to fill out a RxISK report, preferably with an accompanying physician’s letter.

I highly recommend doing so because they will submit these reports to the FDA and EMA and could use all the anecdotal evidence they can get. The RxISK team has a knack for bringing post-drug conditions to the attention of regulators, so this should be well worth your time.

Please complete this report, even if you can’t get a physician, psychologist, or pharmacist to vouch for your health problems being associated with Accutane.

And if you have a minute, remember to comment on the petition to the FDA, no matter which drug got you into this predicament. Use “Anonymous Anonymous” as your first and last names, if you don’t wish to divulge that information.

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Done. Please all the isotretinoin victims, submit yours.

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Again, every post-Accutane patient is urged to comment on the petition.
https://www.regulations.gov/docket?D=FDA-2018-P-4088

I spent a couple hours holding a sign in front of the FDA HQ yesterday morning to get the point across to a few thousand of their employees.

They are aware of this problem.

This also might be the last chance for a long time to have this condition recognized as resulting from Accutane use, so please comment if you haven’t yet. These same steps have worked to encourage upcoming reviews of PSSD from regulatory agencies and there’s no reason it won’t work for us with enough support.

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The reply April 26 of this year:

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Tough decisions huh?

I wonder how many more will fall victim before they move.

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