According to the Examiner (5/17/12), patient Kevin Malley started a hunger strike against Merck on May 13, protesting Merck's reported failure to issue proper acknowledgement of persistent sexual side effects. Malley reportedly took Propecia for five months in 2011 and developed complete erectile dysfunction, memory loss and disorientation.
On April 11, 2012, the FDA announced that the professional labels for both Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) are being expanded to include sexual adverse events that continue after medication is discontinued. Among changes to the labels are inclusion of libido disorders, ejaculation disorders and orgasm disorders that persist, and a revision to include reports of male infertility that normalized or improved after drug discontinuation.
According to the FDA's announcement, the updated warnings for Propecia were based on 421 reports submitted to the Adverse Events Reporting System (AERS) between 1998 and 2011. "Of these, 59 cases reported sexual dysfunction that lasted for at least three months following discontinuation of Propecia, and included erectile dysfunction, decreased libido, problems with ejaculation and orgasm disorders," the FDA noted.
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The updated warning reads, "Reproductive System: Sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride).
Lawsuits have been filed against Merck, alleging men suffered serious and devastating side effects as a result of using finasteride.