Propecia Linked To Health Problems. The drugs Propecia and Proscar, two strengths of finasteride, are treatments for male pattern baldness and enlarged prostate. The drugs have been linked to health problems including erectile dysfunction, infertility, and depression.
Research now suggests new health concerns: Propecia (finasteride) has the potential to mask an important marker for prostate cancer.
Proscar, the stronger dose of finasteride, is indicated by the U.S. Food and Drug Administration (FDA) for use in treatment of prostate cancer.
Men in the U.S. and Canada have filed lawsuits against Merck, the maker of Propecia, alleging that the medication is linked to serious side effects including infertility, loss of libido, and erectile dysfunction. These side effects can last for months or even years after the man stops taking finasteride.
Parker Waichman notes that in addition to sexual side effects, some men who have taken Propecia have experienced suicidal thoughts, and, in rare cases, have committed suicide.
Men who have filed Propecia lawsuit allege that sexual dysfunction, insomnia and emotional symptoms persisted for years after they stopped taking Propecia.
Propecia and Proscar
Finasteride medications are available in two different strengths, for two different uses. The U.S. Food and Drug Administration (FDA) approved Proscar (the 5 mg dose) in 1992 for the treatment of benign prostate enlargement. In 1997, Propecia (the 1mg dose) was approved for the treatment of male-pattern baldness, a common form of hair loss in men.
Propecia and Proscar have been prescribed to more than one million men in the United States.
Finasteride works by blocking the male hormone dihydrotestosterone, which is thought to be a precursor to hair loss. Propecia came with a warning of possible sexual side effects such as decreased libido and erectile dysfunction.
In 2012, after a review of post-marketing reports about Propecia, the FDA directed Merck to update warning labels for finasteride medications to include information about sexual side effects that could continue for some time after treatment ended. The revision to the Propecia label warned of libido disorders, ejaculation disorders, and orgasm disorders that continued after the man stopped taking the drug. The Proscar label revision included a warning that decreased libido could continue after the man stopped taking the drug.
Research that recently appeared online in the Journal of Steroid Biochemistry and Molecular Biology reported that patients with post-finasteride syndrome (PFS) suffer from altered levels of critical brain-function regulators, including neuroactive steroids. The three-year study also found evidence of neuropathy of the pudendal nerve among those study participants who suffer from suffering from severe erectile dysfunction. The pudendal nerve carries signals to and from the genitals, anal area, and urethra.
This small study was conducted at the University of Milan’s Department of Pharmacological and Biomolecular Sciences. Roberto Cosimo Melcangi led a team of 12 researchers. The study had 16 participants with PFS and 25 control participants who did not suffer from Propecia-related sexual dysfunction.
The researchers found a 50 percent rate of depression among the men suffering from PFS.
An earlier study, in the Journal of Clinical Endocrinology & Metabolism, showed that the former finasteride users had impaired sexual function, higher depression scores, a and more cognitive complaints than men in the study who had never used finasteride and others who used finasteride but reported no sexual side effects. The authors explain that the men’s “depressive symptoms and prior finasteride use” may be coincidental or that the men’s depressed mood may contribute to sexual dysfunction. The authors say it is unclear why only a subset of finasteride users experience persistent sexual symptoms and low mood, and they say further research is needed.
More than a thousand Propecia side effects lawsuits have been consolidated in a multidistrict litigation (MDL) in the federal court in the Eastern District of New York. The first cases are expected to be ready to go to trial in fall 2017.
During the pretrial proceedings, plaintiffs hope to obtain information about how much Merck knew about the alleged side effects and when it had that information. In Europe, the label for Propecia was changed in 2008 to note persistent side effects, but in the U.S. the label was not changed until 2012
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