In early September, Public Citizen, on behalf of Post-Finasteride Syndrome Foundation (PFSF), filed a lawsuit against the U.S. Food and Drug Administration (FDA) regarding their inaction on a petition submitted four years ago. PFSF asked, in 2017, that the FDA remove Propecia, a popular medication for male pattern baldness, from market. The drug has been linked to increased risk of depression suicidal ideation, and long-term erected dysfunction.
Lawsuit History Between PFSF and the FDA
Prescriptions for Propecia, the brand-name version of 1mg finasteride, have increased in recent years, as the medication as well as its generic versions are often seen in television and online advertisements. As an alternative to the initial request for the FDA to withdraw its approval of the drug, PFSF asked that drug manufacturers revise the safety information on the labels to warn consumers of potential side effects. The lawsuit filed last month argues that the FDA has acted unlawfully by failing to respond on the original petition.
“The FDA needs to act in a timely way to protect the public from the risks associated with use of Propecia,” said Michael Kirkpatrick, who is serving as lead counsel for PFSF. “The FDA’s failure to act exposes consumers to potentially life-threatening harm.”
Risks of Long-Term Use of Propecia
Long-term use of the hair loss medication can lead to post-finasteride syndrome (PFS), which causes sexual dysfunction and psycho-neurocognitive symptoms, including issues related to mood, sleep, stress response, and more. Unfortunately, men with a PFS diagnosis may suffer from these side effects for years after they stop taking the drug.
The increased risk of suicide after taking finasteride has been studied for years. Vigibase, a global database that tracks harmful side effects from pharmacovigilance agencies, reveals 378 cases of suicidal ideation, 39 suicide attempts, and 88 suicides as a result of finasteride use. Moreover, a study from 2020 found that patients under 45 were particularly vulnerable to depression, anxiety, and suicidal thoughts.
“False information from the FDA leads physicians to dismiss patients, while some even tell them their symptoms are not real,” shared 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.”
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Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.