Popular Hair Loss Drug Associated with High Risk of Depression and Suicidal Ideation
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
On September 8, 2021, Public Citizen filed a lawsuit against the Food and Drug Administration (FDA) regarding the popular hair loss drug, Propecia. The lawsuit was filed on behalf of the Post-Finasteride Syndrome Foundation (PFSF). Public Citizen and PFSF are asking the FDA to remove Propecia from the market, due to an increased risk of depression and suicide ideation associated with the drug.
Propecia prescriptions have significantly increased in the past few years. Four years ago, PFSF filed a citizen petition asking the FDA to revoke its approval of Propecia due to the adverse events being reported after use of the drug. Additionally, the PFSF asked the FDA to require the drug manufacturers to revise the safety information label to disclose the risk of side effects. The FDA has not yet responded to this original petition.
According to September 2021 article, "FDA Sued Over Inaction on Dangerous Hair Loss Medication Propecia", long term use of the drug can lead to several adverse side effects:
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.
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.
In the same article, Dr. John Santmann, the head of PFSF, claims Propecia is doing more harm than good with its current label and FDA status:
“False information from the FDA leads physicians to dismiss patients, while some even tell them their symptoms are not real,” said 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.”
According to the VigiBase global database, which collects information regarding adverse reactions from global pharmacovigilance agencies, there have been 378 reports of suicidal ideation, 39 cases of suicide attempt and 88 cases of suicide associated with Propecia use. In addition to its adverse mental health effects, long term use of Propecia has been linked to post-finasteride syndrome (PFS). PFS can lead to sexual dysfunction and psycho-neurocognitive symptoms, even years after ending use of the drug.
As of September 10, 2021, the FDA has yet to comment on the initial petition filed by PFSF, nor the lawsuit filed on September 8, 2021. Be assured, however, that we will continue to follow the coverage of Propecia as well as watch for possible FDA regulatory action concerning Propecia.
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