5‐Alpha reductase inhibitor related litigation: A legal database review

Abstract

Background: 5α-reductase inhibitors are commonly prescribed medications with multiple side effects used in the treatment of male pattern hair loss and benign prostatic hyperplasia. These side effects including "post-finasteride syndrome" may result in lawsuits. Objectives:To characterize lawsuits involving the adverse side effects of 5α-reductase inhibitor to better understand drivers of litigation and outcomes.Methods: Legal cases were queried from Nexis Uni using the search terms "5-alpha reductase inhibitor" as well as specific agents "finasteride," "dutasteride" in combination with "malpractice," "negligence," "damage," "loss," "side effect," and "complication."Secondary review was performed with publicly available data on "In Re: Propecia." Relevant cases were reviewed and pertinent characteristics were extracted and summarized using descriptive statistics.Results: Our search yielded 156 unique legal cases in the Nexis Uni database from April 2003 to May 2021. Only 18 of these cases met the inclusion criteria. Adverse events experienced by patients included medication side effects (n = 12, 66.7%), delayed cancer diagnosis (n = 3, 16.7%), and lack of symptom improvement (n = 3, 16.7%). The identity of the plaintiffs were most commonly patients themselves (n = 15, 83.3%). Defendants include pharmaceutical companies (n = 6, 33.3%), a combination of parties (n = 5, 27.8%), and physicians (n = 5, 27.8%) alone. The allegations included sexual side effects such as erectile dysfunction (n = 6, 33.3%) and decreased libido (n = 4, 22.2%). These prescriptions were made for benign prostatic hyperplasia (n = 9, 50%), male pattern hair loss (n = 7, 38.9%), and feminizing hormone therapy (n = 2, 11.1%). Several of these cases involved the same plaintiffs in related cases. No verdicts were against physicians.We noted a largely settled lawsuit involving more than 1000 plaintiffs with limited data on harms alleged and a $4.3 million settled amount. Of the total cases that resulted in a verdict, 9/18 were within the last 3 years.

Finasteride delays atherosclerosis progression in mice and is associated with a reduction in plasma cholesterol in men

“…However, the upregulation of the pathway named "xenobiotic metabolism" in finasteride-exposed mice could be interpreted as hepatic toxicity ( 97 ), which would agree with some reports suggesting that finasteride causes liver damage and other alterations ( 98 ). While side effects are considered rare, recent findings shed light on possible adverse health outcomes of finasteride in people ( 99 ). We failed to observe alterations in circulating markers for liver damage in response to any dose of finasteride compared to finasteride-free diet-fed littermates that, together with the absence of body weight or food intake alterations, allow us to rule out toxic effects in our experimental model ( supplemental Table S1 ).…”

Case report: a study of the clinical characteristics and genetic variants of post-finasteride syndrome patients

“…Finasteride is a synthetic 5α-reductase inhibitor that effectively reduces dihydrotestosterone (DHT) in the blood and prostate by inhibiting the conversion of testosterone into DHT (1)(2)(3)(4)(5). Finasteride is widely used in the treatment of benign prostatic hyperplasia (BPH) and androgenic alopecia (AGA).…”