FDA Petition to Add Sexual Side Effects to Accutane Drug Label

Dubbya_B

Member
Staff member
Jun 27, 2018
36
22
8
USA
#1
RxISK recently submitted a citizens petition to the FDA to add warnings of sexual side effects to the Accutane/Isotretinoin label.
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:
Citizen-petition-Sexual-side-effects-of-isotretinoin.pdf
125.36 KB


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!
 
Last edited:

flynn

Administrator
Staff member
Feb 28, 2018
78
74
18
#2
RxISK recently submitted a citizens petition to the FDA to add warnings of sexual side effects to the Accutane/Isotretinoin label.
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:
Citizen-petition-Sexual-side-effects-of-isotretinoin.pdf
125.36 KB


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!
Done
 
Likes: Dubbya_B

Dubbya_B

Member
Staff member
Jun 27, 2018
36
22
8
USA
#4
...Just another plea to comment.

7 comments so far and only 3 are from US citizens.

I am planning on protesting the FDA's refusal to recognize sexual side effects this winter.

Please support this initiative to have sexual side effects added to the drug label in any way you can.
 

Dubbya_B

Member
Staff member
Jun 27, 2018
36
22
8
USA
#5
Update:

I spent the morning of December 21st in front of the FDA HQ with a sign that read "1/3 of Teens Reporting Sexual Side Effects Took Accutane, These Effects Can be Permanent, But the FDA Doesn't Care About Ruined Lives", so they are well aware of this issue. There seemed to be quite a few less employees present than during the last protest, but this appears to have been a pivotal moment as the day prior to the holiday break and month-long government shutdown. Hopefully, it will still be fresh in their minds.

If anyone else has ideas to put forth to garner attention for this petition, please share them.
 
Likes: flynn