The FDA issued an update to warnings about use of testosterone replacement products, indicating they are only approved for men with documented medical conditions. FDA stated, “[T]he 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.” The initial warning was issued on January 31, 2014.
FDA is requiring firms to add warnings about the increased risk of heart attacks and stroke in patients taking testosterone and will require label changes to clarify the approved uses of these medications. “Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism.”
FDA goes on to say that they have “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 and safety of this use have not been established.”
The Agency also notes that while some studies show an increased risk of cardiovascular events, including heart attack, stroke and death, other studies do not. In an attempt to clarify this, FDA is also asking manufacturers to collaborate to conduct a definitive clinical study to “more clearly address” these risks.
To see the Agency’s full warning and additional information, please click here.
