An investigative report published earlier this month by Reuters shows that Merck & Co. and the U.S. Food and Drug Administration (FDA) were aware of reports of suicidal behavior in men taking Merck’s popular male pattern baldness drug, Propecia, when the decision was made not to include warnings about this potentially life-threatening side effect risk during a 2011 drug label update. If you have experienced suicidal thoughts or behavior while taking the hair loss drug Propecia, or if a loved one committed suicide and you believe Propecia to be the cause, you may be eligible to file a claim against Merck for damages. Contact us today to find out how we can help.
Propecia (finasteride) is a male pattern baldness drug widely prescribed to treat hair loss in men. Finasteride was originally developed by Merck in 1992 as a treatment for benign prostatic hyperplasia, marketed as Proscar. In 1997, a lower-dose version of finasteride was approved as a treatment for male pattern baldness, or androgenic alopecia, sold under the brand name Propecia. Male pattern baldness affects more than 50 million American men and Propecia is the only oral prescription drug FDA-approved to treat the condition. As a result, prescriptions for finasteride have skyrocketed in recent years among men struggling with the effects of premature hair loss. In 2020 alone, more than 2.4 million people in the U.S. were prescribed finasteride, more than double the number of prescriptions written just five years earlier.
Much of the debate centering around Propecia in recent years has involved claims that the medication causes sexual dysfunction and other devastating sexual side effects that may persist even after the drug treatment is discontinued. However, we now know that Propecia may also increase the risk of suicidal thoughts and behaviors in users. According to court documents and internal records unsealed late last month as part of the ongoing Propecia sexual dysfunction litigation, Merck and U.S. drug regulators knew about this potentially life-threatening risk and decided against disclosing it to the public when the Propecia drug label was updated in 2011. In fact, it was back in 2009 that Merck conducted an internal “risk management” assessment, which identified more than 200 reports of depression, including suicidal thoughts, in men taking Propecia.
Merck was given a chance to warn consumers that men taking Propecia may be more likely to experience suicidal behavior several years after the risk analysis, when a Propecia label update was being considered by the FDA. Despite being aware of the potential risk of Propecia-related suicide and suicidal thoughts, Merck submitted a request to add a warning only about a possible depression risk among Propecia users, with no mention of any warnings related to suicide. At that time, an FDA safety evaluator recommended including a warning about suicidal thoughts and behavior, citing adverse event reports involving nine suicides and other suicidal behaviors among people taking finasteride.
In a report submitted in November 2010, FDA safety evaluator Namita Kothary wrote that while the suicide-related events linked to Propecia were difficult to evaluate due to a lack of conclusive information, “we cannot exclude that finasteride may have contributed to the events.” However, the FDA ultimately sided with Merck, declaring that the suicide rate among Propecia users, however troubling, was “lower than would be expected in this patient population.” Since the 2011 Propecia label update, more than 700 adverse events involving suicide and suicidal thoughts have been reported to the FDA in connection with Propecia or generic versions of the male pattern baldness medication, including as many as 100 patient deaths.
For most patients, the potential risk of suicidal behavior far outweighs any possible hair loss prevention benefits of Propecia, which is why European and Canadian regulators have required a warning about the risk of suicidal thoughts on the Propecia label. Since Propecia entered the market in the late 1990s, the FDA has received hundreds of reports of suicide and suicidal ideation in Propecia users, yet there are no warnings about these risks on the Propecia label in the U.S. Former Propecia users and their loved ones are now filing lawsuits claiming that Merck and the FDA failed to properly warn American consumers about the possibility of Propecia triggering potentially life-threatening side effects in users. If you or someone you know has suffered a serious side effect allegedly linked to Propecia, such as suicidal ideation or persistent sexual dysfunction, contact a knowledgeable Propecia injury attorney today to discuss your legal options.