In its Drugs@FDA database, FDA has at least nine versions of the Propecia label going back to 2001. This post will trace the history of changes to adverse effects in the label for consumers.
A summary of label changes:
- 2001 – “Side effects went away in men who stopped taking Propecia”
- 2002 – Testicular pain added
- 2004 – Breast adverse events added
- 2010 – Breast enlargement added
- 2011 – First mention of depression; rare instances of breast cancer
- 2012 – Added reports of sexual adverse events that “continued after stopping the medication” and “male infertility / poor quality of semen”
- 2014 – Angioedema added to prescriber label
- 2021 – Hematospermia added to prescriber label
- 2022 – FDA requires 1) addition of suicidal ideation and behavior to postmarketing events; 2) addition of sexual adverse events to Patient Counseling Information
2001 – “Side effects went away in men who stopped taking Propecia”
“A small number of men experienced sexual side effects,” the 2001 label reads. “…These side effects went away in men who stopped taking PROPECIA.”
2002 – Testicular pain added
The term post-marketing reports refers to adverse effects reported in general use after the drug is approved. A revision in 2002 replaced postmarketing reports for Proscar (finasteride at 5mg for enlarged prostate) with similar postmarketing reports for Propecia, but with a new adverse effect, testicular pain.
2004 – Breast adverse events added
In 2004, the Propecia label added a warning regarding certain breast changes:
2010 – Breast enlargement added
2011 – First mention of depression
A document dated March 11, 2011 does not have a label for patients, but mentions depression in the Postmarketing Experience section—apparently the first mention of this adverse effect in a Propecia label:
In April 2011, the consumer label was updated to include depression:
In June 2011, another update was issued noting rare reports of male breast cancer:
2012 – Major revision including reports of adverse effects that continued after stopping the medication
In June 2012, the label was updated to include the following changes:
1. Language of side effects was modified:
- “Less desire for sex” was changed to “decrease in sex drive”
- “Difficulty in achieving an erection” was revised to “trouble getting or keeping an erection”
2. Three new postmarketing experiences were added, noting that they continued after stopping the medication (emphasis added):
- decrease in sex drive that continued after stopping the medication
- problems with ejaculation that continued after stopping medication
- difficulty in achieving an erection that continued after stopping the medication
This was also added: “male infertility and/or poor quality of semen.”
A separate post describes a misleading communication from FDA following this label change.
2014 – Angioedema added to prescriber label
In 2014, an update was made to add angioedema to the Postmarketing Experience section of Prescribing Information. (An FDA letter said it should be included in the consumer label, but it is not included in the version available from Drugs@FDA.)
2021 – Hematospermia added to prescriber label
On June 15, 2021, the FDA approved the addition of the adverse reaction hematospermia to the Postmarketing Experience section of the prescriber label. The approval letter is here.
2022 – Suicidal ideation and behavior added; sexual adverse events added to Patient Counseling Information
On August 1, 2022, Organon updated Prescribing Information to include “suicidal ideation and behavior” in section 6.2, Postmarketing Experience. It was not added to Patient Information. The most recent Patient Information on the Drugs@FDA website was revised in April 2012 (see last 4 pages).
This change was required in FDA’s response to a 2017 petition from the Post Finasteride Syndrome Foundation:
We are requiring the addition of suicidal ideation and behavior to the list of nervous system/psychiatric reactions in the ADVERSE REACTIONS (Postmarketing Experience) section of the Propecia labeling.U.S. Food and Drug Administration. Final Response Letter from FDA CDER to Post-Finasteride Syndrome Foundation. Page 43. June 8, 2022.
Other required changes include:
- Add sexual adverse events mentioned in the Adverse Reactions (Clinical Trials Experience) section to Patient Counseling Information.
- Add the following to the Patient Counseling Information section: decreased libido, erectile dysfunction, and ejaculation disorder, including decreased ejaculate volume.