Adverse effects on the Propecia label: a history of changes

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 – Added reports of depression; erectile dysfunction that discontinued after stopping the medication; and rare instances of breast cancer
  • 2012 – Added reports of additional 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”

Propecia label as of Aug 12, 2001

“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.

Propecia label excerpt as of Apr 10, 2002

2004 – Breast adverse events added

In 2004, the Propecia label added a warning regarding certain breast changes:

Propecia label excerpt as of Oct 21, 2004

2010 – Breast enlargement added

Propecia label excerpt as of Mar 24, 2010

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:

Propecia label as of Mar 11, 2011

In April 2011, the consumer label was updated to include depression:

Propecia label excerpt as of Apr 13, 2011

In June 2011, another update was issued noting rare reports of male breast cancer:

Propecia label excerpt as of Jun 9, 2011

Document: Approval Package for Propecia Labeling Changes, Mar 11, 2011


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.

Propecia label excerpt as of Apr 11, 2012

Documents


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.)

Propecia label as of Jan 31, 2014

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.

Propecia label as of Jun 15, 2021

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.