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Rates of testosterone replacement therapy (TRT) prescriptions have increased markedly in recent years, with global testosterone sales growing twelvefold from 2000 to 2011. Higher growth rates have been seen in the United States and Canada than in other Western countries. 1
Detrimental Effects for Unapproved Uses
Even though testosterone treatment is increasingly promoted by direct-to-consumer advertising, the FDA has only approved TRT for men who physiologically produce no or low amounts of testosterone, citing concerns about detrimental effects in people who do not need the therapy.
In addition, reports have indicated that children who come into contact with someone taking a topical testosterone therapy drug could be harmed, and all testosterone products carry black box warnings, the highest warning that can be given to a drug, in their labeling regarding the risks accompanying secondary exposure. 2
FDA Alerts Regarding Cardiovascular Events and Death
On January 31, 2014, based on studies that suggested an increased risk of cardiovascular events among groups of men who were prescribed testosterone therapy, the FDA issued a safety alert regarding an investigation into the risk of stroke, heart attack and death in men taking testosterone supplements. The agency has stated it will continue to monitor risks related to TRT. However, long-term effects are still unknown.
The alert also advises doctors and other medical professionals to take the risks and benefits of FDA-approved testosterone treatment under consideration before writing any prescriptions. Furthermore, patients should be sure to read drug labels and follow the medication directions accordingly. 3
On March 3, 2015, the FDA made publicly available an update about this Safety Communication. FDA requirements include a label change for all manufacturers regarding “the possible increased risk of heart attacks and strokes associated with testosterone use.” The FDA also advises for healthcare professionals to discuss this possibility with their patients when the medication is prescribed.