Persistent
Sexual Dysfunction Controversy
Ken Washenik, MD, Ph.D.
International
Society of Hair Restoration Surgery 19th annual scientific meeting
October
2011
Anchorage,
Alaska
Persistent Sexual Dysfunction Controversy/Case Reports
Ken Washenik,
MD, Ph.D., is the Chief Executive Officer of the Aderans Research Institute, a biotechnology firm involved
in researching tissue engineered hair follicle neogenesis
and cellular based hair restoration.
The former director of the Dermatopharmacology Unit at the New York University School
of Medicine, Dr. Washenik continues to serve as a clinical
investigator and faculty member in the Department of Dermatology. His Ph.D. is
in Cell Biology and focused on hormone metabolism. He frequently lectures on
the-effects of hormones on the skin including their effects on hair loss and
growth.
K. Washenik: Employment; Aderans Research Institute/Bosley.
Ownership Interest (owner, stock, stock options); Bosley. Ownership Interest (royalty, patent, or
other intellectual property); Aderans Research
Institute.
ABSTRACT:
For more than a decade, finasteride has been
prescribed for the treatment of male pattern hair loss. A discussion of the
uncommon possibility of sexual side effects (e.g., decreased libido, erectile
dysfunction, etc.) has been part of that process since its approval for this
indication. However, the clinical trial data that revealed the possibility of
these side effects indicated that, should they occur, these side effects are
temporary and will resolve if the medication was discontinued. The data also
indicated that, for most men who experienced one of these side effects, these
side effects would also resolve if a patient continued to take the medication.
Recently, however, the presence of a number of
post-marketing reports of persistence of sexual side effects, despite
discontinuation of the medication, has led to the addition of a notification of
these reports to the package insert of finasteride in the United Kingdom,
Sweden and, most recently, the United States.
This presentation will review the
controversy that has arisen concerning the post-marketing reports of persistent
sexual side effects secondary to finasteride use. The definition of
post-marketing reports will be covered as will two recent publications in the
Journal of Sexual Medicine that highlighted the topic of possible persistence
of finasteride related side effects and a survey of patients reporting
persistent sexual side effects. This discussion will be part of a session that
examines the side effect profile of finasteride from clinical trial data,
physician clinic experience, post marketing reports and the occurrence of these
types of complaints in the general male population.
