Study Findings Don't Support FDA's Testosterone Therapy-VTE Warning
"In 2014, the [U.S.] Federal Drug Administration required manufacturers to add a warning about potential risks of VTE to the label of all approved testosterone products," study author Jacques Baillargeon, PhD, a professor of epidemiology at the University of Texas Medical Branch at Galveston, said in a university news release. "The warning, however, is based primarily on post-marketing drug surveillance and case reports. To date, there have been no published comparative, large-scale studies examining the association of testosterone therapy and the risk of VTE," he noted.
Baillargeon and his colleagues looked at data from 30,572 American men, aged ≥40. The researchers found that having a prescription for testosterone therapy was not associated with an increased risk of VTE. The researchers also studied various forms of testosterone therapy, including topical creams, transdermal patches, and intramuscular injections. No increased risk of VTE was found with any of these forms, the researchers said.
But due to the study's design, it's not possible to say definitively that there's no VTE risk associated with testosterone therapy. Baillargeon added that he recognized the need for more study. "It's also important to note that further research needs to be conducted to rigorously assess the long-term risks of testosterone therapy," he said.