Propecia Side Effect May Be Long-Lasting. Approved in 1997 to treat male pattern baldness, Propecia (finasteride 1 mg) is part of a class of drugs that are known as 5-alpha reductase inhibitors (5-ARIs). Propecia’s active ingredient may interfere with male hormones, which include testosterone derivatives. When prescribed in higher doses, the drug is sold under the brand name Proscar and is approved as a treatment for men who have been diagnosed with benign prostatic hyperplasia (enlarged prostate) or urinary problems.
Both drugs, manufactured by Merck & Co.-have been prescribed to more than one million men in the United States and have been tied to serious, sometimes devastating, side effects including sexual side effects, suicidal ideation, and suicide. Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in drug injury claims, including claims involving Propecia. The firm continues to offer free, no-obligation legal consultations.
In 2012, the U.S. Food and Drug Administration (FDA) announced changes to Propecia’s label warning about the risk of sexual disorders associated with libido, ejaculation, and orgasm issues. At the time of its announcement, the agency pointed out that causal links had not been recognized and also pointed out that just a small number of men experienced sexual side effects. Until the FDA ordered that label change, warnings provided to U.S. users of the drug suggested that these problems typically resolve. In April 2012, CBS News reported that the FDA had received 421 reports of sexual dysfunction associated to Propecia or Proscar; 59 of those men reported their side effects continued for at least three months after they stopped taking the drugs.
Also in 2012, Merck changed its warning label to indicate that sexual problems may persist even after Propecia treatment had been stopped. FDA then ordered the new warnings for Propecia and Proscar labels detailing possible long-lasting male sexual side effects associated with the drugs. Until the agency ordered the label change, warnings provided to U.S. Propecia and Proscar users suggested that these problems typically resolve. Meanwhile, Merck changed the Propecia label in Europe several years prior to warn that the drugs may lead to permanent erectile dysfunction.
A prior report on Propecia sexual side effects seen in some men may be permanent, not the first time that similar associations have been made with the popular hair loss drug. In some cases, patients have alleged that their side effects worsen after they stop taking Propecia. Previous evidence discovered by consumer advocacy group, the Institute for Safe Medication Practices (ISMP), in the FDA’s Adverse Event Reporting System (FAERS) revealed permanent Propecia sexual side effect risks. “Nearly 20 years after approval, evidence is now emerging that the sexual side effects of finasteride may sometimes be irreversible and were most notable in the younger men taking finasteride for male pattern baldness,” the ISMP study indicated, according to the previous QuarterWatch report.
Other earlier research also reported potential links with Propecia to sexual side effects, including erectile dysfunction, impotence, diminished sex drive, and orgasm problems. Other research suggested a tie between Propecia use and depression. Again, possible complications were seen to potentially continue years after treatment was stopped.
The Journal of Sexual Medicine published a study in 2010 linking Propecia to persistent sexual dysfunction, including new-onset sexual side effects such as low sex drive, erectile dysfunction, decreased arousal, and orgasm problems. Study participants took Propecia for an average of 28 months and persistent sexual side effects lasted an average of 40 months from the time the drug was discontinued. The Journal of Sexual Medicine published another study following the 2010 study that confirmed the 2010 findings. According to the newer study, 96 percent of the men involved in the research who experienced sexual side effects after taking Propecia continued to suffer from these symptoms one year after they stopped taking the drug.
The Journal of Clinical Psychiatry published a study in 2012 linking Propecia to depression that found that most-75 percent-of the men taking Propecia in this study reported feeling depression symptoms; just 10 percent in the control group reported similar feelings.
Propecia Litigation Progressing
Hundreds of lawsuits are pending in state and federal courts over Propecia involving allegations of side effects that include loss of libido, erectile dysfunction (ED), and infertility. For instance, lawsuits have been consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of New York and in state courts in New Jersey. Plaintiffs similarly allege that Merck was aware of the risks of ongoing side effects, pointing out that Propecia labels in other countries were changed as far back as 2008 and indicated those risks.
A report published in late November 2016 by Vice discussed a man who committed suicide earlier this year. His family blames Propecia for the man’s death. In 2015, Health Canada issued a summary safety review indicating that the World Health Organization (WHO) received 170 reports of suicidal thoughts and 56 reports of completed suicides associated with finasteride, the active ingredient in Propecia. Neither WHO nor Health Canada made conclusions about the potential link between Propecia and suicide and suicidal ideation.
Vice also indicated that, in October 2016, a judge selected four bellwether cases to initiate Propecia lawsuits. Those lawsuits similarly allege that men were not appropriately warned about the risk of severe, even catastrophic, side effects such as sexual dysfunction and suicidal thoughts. As of December 2016, Propecia litigation continues to progress with the selected bellwether cases. Bellwethers are chosen in large litigations as the first to reach trial. The outcomes of these trials, while not binding on other cases, do provide the involved parties with additional insight as to how juries will likely respond to testimony and evidence that would be presented in other cases. Bellwether trends often help quicken settlement negotiations.
Currently, Merck & Co. faces over 1,200 lawsuits over various sexual side effect allegations due to the plaintiffs taking Propecia. The plaintiffs also allege Merck did not warn patients that the sexual side effects associated with Propecia may be permanent, even after the drug was stopped. More than 1,000 lawsuits have been consolidated for pretrial proceedings in an MDL in the federal court in the Eastern District of New York. The first cases are now expected to reach trial in the fall of 2017, one year later that originally thought.
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