March 3, 2015 – FDA issued an update to its 2014 Drug Safety Communication, requiring all manufacturers of testosterone products to revise their labels with warnings “about a possible increased risk of heart attacks and strokes…” The updated Safety Communication further cautions that neither the safety, nor the benefit of Low T drugs has “been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.” As a result, FDA is further requiring that testosterone labeling must be updated to clarify that Low T drugs are only approved in men who have low testosterone levels due to certain narrowly defined medical conditions. Finally, the updated Safety Communication requires that manufacturers of testosterone products must “conduct a well designed clinical trial to more clearly address the question of [possibly increased cardiovascular risk].”
The new Safety Communication was prompted by FDA’s conclusion “that there is a possible increased cardiovascular risk associated with testosterone use.” The conclusion is based on evidence from both published literature and expert feedback from a September 2014 FDA advisory panel meeting. Furthermore, “FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging.” The benefits or safety of such use have never been established.
On January 31, 2014, FDA issued its original Drug Safety Communication, announcing it would “reassess the cardiovascular safety of testosterone therapy.” The safety statement was prompted by research showing increased risk of serious cardiovascular issues associated with testosterone therapy, including heart attack, stroke, and death. On September 17, 2014, an FDA advisory panel voted overwhelmingly in favor of updating testosterone labeling to restrict the intended uses of testosterone therapy. It also recommended additional safety studies to assess cardiovascular risks.