madman
Super Moderator
* Bhasin noted that, like fellow academics and endocrinologists, he has historically been cautious around testosterone therapy. “In the last 5 years or so, we’ve learned a lot more, and I’ve changed my position,” he said. “On one side, it’s very rigid, and on the other, it’s touted as the cure to everything. As always, I think the middle road is the best path.”
Testosterone’s Next Act
Despite divisions over the proposed label changes, experts largely agree on how testosterone therapy should—and should not—be prescribed. None advocate administering treatment based on symptoms alone, and they all concur that men receiving therapy require ongoing monitoring to ensure testosterone levels remain in the normal range and that adverse effects are avoided.
“If you don’t get a good response, you stop the therapy,” Nissen said. “It should not be used as a general tonic for people with low energy.”
Before any proposed label changes take effect, drug manufacturers must formally submit the updates to the FDA for review. If the FDA approves the new language, it will be published in official prescribing information for health care professionals.
Although critics worry that broader labeling could unintentionally lower the threshold for prescribing testosterone, particularly in primary care settings where clinicians may have less experience evaluating hypogonadism, supporters say the revisions may make it easier for physicians to identify appropriate candidates and help eligible patients obtain insurance coverage.
“A lot of practitioners have not been well trained in testosterone replacement,” Christine said. “And a lot of patients who qualify for this treatment have not had easy or affordable access to it.”
Still, complete consensus isn’t likely. Bhasin noted that, like fellow academics and endocrinologists, he has historically been cautious around testosterone therapy. “In the last 5 years or so, we’ve learned a lot more, and I’ve changed my position,” he said. “On one side, it’s very rigid, and on the other, it’s touted as the cure to everything. As always, I think the middle road is the best path.”
Testosterone’s Next Act
Despite divisions over the proposed label changes, experts largely agree on how testosterone therapy should—and should not—be prescribed. None advocate administering treatment based on symptoms alone, and they all concur that men receiving therapy require ongoing monitoring to ensure testosterone levels remain in the normal range and that adverse effects are avoided.
“If you don’t get a good response, you stop the therapy,” Nissen said. “It should not be used as a general tonic for people with low energy.”
Before any proposed label changes take effect, drug manufacturers must formally submit the updates to the FDA for review. If the FDA approves the new language, it will be published in official prescribing information for health care professionals.
Although critics worry that broader labeling could unintentionally lower the threshold for prescribing testosterone, particularly in primary care settings where clinicians may have less experience evaluating hypogonadism, supporters say the revisions may make it easier for physicians to identify appropriate candidates and help eligible patients obtain insurance coverage.
“A lot of practitioners have not been well trained in testosterone replacement,” Christine said. “And a lot of patients who qualify for this treatment have not had easy or affordable access to it.”
Still, complete consensus isn’t likely. Bhasin noted that, like fellow academics and endocrinologists, he has historically been cautious around testosterone therapy. “In the last 5 years or so, we’ve learned a lot more, and I’ve changed my position,” he said. “On one side, it’s very rigid, and on the other, it’s touted as the cure to everything. As always, I think the middle road is the best path.”
