FDA Petition to Add Sexual Side Effects to Accutane Drug Label

Dubbya_B

New member
Jun 27, 2018
16
9
3
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
72
63
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