Public Citizen to FDA: Pull Propecia from the Market

The petition asks the FDA to remove the popular hair loss drug from the market due to evidence of serious risk of patient injury, including depression and suicidal ideation.

Public Citizen today filed a lawsuit on behalf of the Post-Finasteride Syndrome Foundation (PFSF) against the U.S. Food and Drug Administration (FDA) for the FDA’s inaction on a petition submitted by PFSF in September 2017.

The petition asks the FDA to remove the popular hair loss drug, Propecia, from the market due to evidence of serious risk of patient injury, including depression and suicidal ideation.

“The FDA needs to act in a timely way to protect the public from the risks associated with use of Propecia,” says Michael Kirkpatrick, the Public Citizen attorney serving as lead counsel for PFSF, in a news release. “The FDA’s failure to act exposes consumers to potentially life-threatening harm.”

Four years ago, PFSF filed a citizen petition requesting that FDA withdraw its approval of Propecia for treatment of male-pattern hair loss, due to the significant risks that the drug poses to patients. Alternatively, PFSF requested that FDA require drug manufacturers to revise the safety information on the labeling and add boxed warnings to disclose the risky potential side effects. FDA has yet to respond. 

The lawsuit filed today claims that FDA has acted unlawfully in failing to act on PFSF’s petition.

Long-term use of Propecia can lead to post-finasteride syndrome (PFS), a syndrome characterized by sexual dysfunction and psycho-neurocognitive symptoms. Men who experience PFS may continue to suffer from these symptoms years after they stop taking the drug, the group points out.

The risk of suicidal ideation associated with finasteride has been known for years. The VigiBase global database, which tracks adverse effects from global pharmacovigilance agencies, lists 378 cases of suicidal ideation, 39 cases of suicide attempt and 88 cases of suicide associated with finasteride use. Additionally, a 2020 study concluded that patients under age 45 who used finasteride for hair loss were vulnerable to depression, anxiety and suicidal ideation, they note.

The drug also inhibits multiple steroid hormone pathways necessary to the formation of brain neurosteroids that regulate many critical functions in the central nervous system, like sexual function, mood, sleep, cognitive function, the stress response, and motivation.

“False information from the FDA leads physicians to dismiss patients, while some even tell them their symptoms are not real,” says John Santmann, M.D., the head of PFSF. “Without effective treatments for PFS, use of this cosmetic drug can lead to a lifetime of side effects. The drug ruins more lives every day and has no business being on the market.”

Finasteride has also been linked to erectile dysfunction that persists months after treatment ends. In 2017, Northwestern University researchers published a study that one-third of the men who developed new erectile dysfunction while taking finasteride continued to have erectile dysfunction more than 90 days after drug discontinuation. An additional 2006 Propecia Periodic Safety Update Report found that some men did not have resolution of the sexual side effects at the end of clinical trials.

The complaint filed today in the U.S. District Court for the District of Columbia is available here.