Now a new study published
in the Journal of Sexual Medicine finds that side effects may not only
continue after stopping finasteride, but they may last for months or
even years.
In the study, Dr. Michael
Irwig of George Washington University and his colleagues surveyed 54
men under age 40 who reported experiencing side effects for three months
or more after stopping the medication Propecia. The patients reported a
variety of sexual problems including erectile dysfunction, low libido,
trouble having an orgasm, and shrinking and painful genitals. Some men
also reported neurological problems like depression, anxiety and
cognitive haziness.
For 96% of the men, the
sexual problems lasted more than a year after they quit using the drug.
None of the men had sexual, medical or psychiatric complaints before
taking Propecia.
The study sample was
small and the authors acknowledge that it may be skewed to include only
men who were most negatively impacted by the drug. Most of the
participants were recruited through an Internet forum called Propeciahelp.com, for men experiencing persistent side effects.
Still, the authors argue
their findings may signal potentially serious risks for men using
finasteride. "Our findings make me suspicious that this drug may have
done permanent damage to these men," Irwig told ABC News.
The FDA's updated warning labels for finasteride were based on a review
of post-marketing reports of sexual dysfunction. The agency reviewed
421 post-marketing reports of sexual side effects related to Propecia
from 1998 to 2011; out of these cases, 59 reported adverse sexual
effects lasting over three months after discontinuing the drug. For
Proscar, the FDA reviewed 131 cases of erectile dysfunction and 68 cases
of decreased libido from 1992 to 2010. As Healthland reported in April:
Finasteride
labels will now warn users that Propecia's side effects can include
libido disorders, ejaculation disorders, and orgasm disorders that
continue after discontinuation of the drug and that Proscar can lead to
decreased libido that continues after quitting the drug. Both
medications will receive a new description of reports of male
infertility and poor semen quality that normalized or improved after
stopping therapy.
"Despite the
fact that clear causal links between finasteride (Propecia and Proscar)
and sexual adverse events have not been established, the cases suggest a
broader range of adverse effects than previously reported in patients
taking these drugs," the FDA said in a statement.
Irwig acknowledges that
the number of men experiencing long-lasting side effects from
finasteride is small, although the incidence of sexual side effects in
clinical trials was around 2%, the incidence of persistent sexual side
effects is unknown, but likely less than 0.1%. "But because the
medication is prescribed so commonly, it's still a lot of people, likely
several thousand men around the world," Irwig told ABC News.
Both the FDA and Merck maintain that finasteride is safe and effective.
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