title: Testosterone therapy in the new era of Food and Drug Administration oversight.
abstract: The Food and Drug Administration (FDA) introduced changes in labeling and indications for use to testosterone products in 2015 due to a possible increased risk of cardiovascular (CV) events. This decision was made based on six clinical studies-some that supported an increased CV risk, and some that did not. Since this decision, additional studies have been published examining the interplay between hypogonadism, CV risk, and testosterone, demonstrating that the risk may be lower than originally estimated. Clinicians are placed in a difficult position, as studies support an increased mortality risk in hypogonadal men, but also an increased risk of CV events in men on testosterone therapy. As a result, many clinicians will be more selective in their prescribing of testosterone. In this review, we examine how these new guidelines arose and how they may affect prescribing habits.
authors.forename: Bethany
authors.initials: B
authors.lastname: Desroches
authors.forename: Taylor P
authors.initials: TP
authors.lastname: Kohn
authors.forename: Charles
authors.initials: C
authors.lastname: Welliver
authors.affiliation: ;
authors.forename: Alexander W
authors.initials: AW
authors.lastname: Pastuszak
keywords: Hypogonadism; cardiovascular risk; drug prescriptions; low testosterone; off-label use; physician’s; practice patterns; united states food and drug administration