US FDA warns on over-prescribing of testosterone products

The US Food and Drug Administration is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications.

The FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.

Last July, Health Canada advised patients and health care professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.