madman
Super Moderator
This is key here!
* "This now clarifies and substantiates the fact that there are not increased risks from a cardiovascular standpoint with [testosterone] therapy, at least at the doses studied," says Landon Trost, MD.
www.urologytimes.com
"This now clarifies and substantiates the fact that there are not increased risks from a cardiovascular standpoint with [testosterone] therapy, at least at the doses studied," says Landon Trost, MD.
When it comes to the FDA’s recent class-wide labeling changes for testosterone products,1 Landon Trost, MD, predicts that although the changes won’t significantly affect frequent prescribers of testosterone who are well versed in research on the treatment, it will nonetheless have an impact.
“A lot of people see a black box warning as just a major red flag in and of itself, and so by removing that, it removes a lot of the ambiguity surrounding the risks and safety of the of the product…I think some providers who don't spend their entire life studying testosterone will be impacted by it quite a bit, because even from a patient standpoint, they receive the prescription, they see this on there, and they think, ‘oh my gosh, what's my provider doing?’ In reality, this now clarifies and substantiates the fact that there are not increased risks from a cardiovascular standpoint with [testosterone] therapy, at least at the doses studied,” said Trost, founder and director of the Male Fertility and Peyronie’s Clinic in Orem, Utah.
During the interview, Trost was also asked about the retention of “Limitation of Use” regarding age-related hypogonadism.
“Testosterone isn't meant to be a lifestyle supplement-type drug, but it's meant to be used in certain indications, and so it's always good and appropriate to maintain indications like that. Now, the specific terms they use, you could argue that the data may or may not support that. There's debate, for example, whether age is truly relevant and whether testosterone does continue to decline with aging. Again, the science is back and forth on that right now. So if anything, it may be a little bit too specific for what the data would support, but the concept of a targeted group who's appropriate for therapy is appropriate,” Trost commented.
* "This now clarifies and substantiates the fact that there are not increased risks from a cardiovascular standpoint with [testosterone] therapy, at least at the doses studied," says Landon Trost, MD.
Landon Trost, MD, on the impact of the FDA labeling changes for testosterone products
"This now clarifies and substantiates the fact that there are not increased risks from a cardiovascular standpoint with [testosterone] therapy, at least at the doses studied," says Landon Trost, MD.
"This now clarifies and substantiates the fact that there are not increased risks from a cardiovascular standpoint with [testosterone] therapy, at least at the doses studied," says Landon Trost, MD.
When it comes to the FDA’s recent class-wide labeling changes for testosterone products,1 Landon Trost, MD, predicts that although the changes won’t significantly affect frequent prescribers of testosterone who are well versed in research on the treatment, it will nonetheless have an impact.
“A lot of people see a black box warning as just a major red flag in and of itself, and so by removing that, it removes a lot of the ambiguity surrounding the risks and safety of the of the product…I think some providers who don't spend their entire life studying testosterone will be impacted by it quite a bit, because even from a patient standpoint, they receive the prescription, they see this on there, and they think, ‘oh my gosh, what's my provider doing?’ In reality, this now clarifies and substantiates the fact that there are not increased risks from a cardiovascular standpoint with [testosterone] therapy, at least at the doses studied,” said Trost, founder and director of the Male Fertility and Peyronie’s Clinic in Orem, Utah.
During the interview, Trost was also asked about the retention of “Limitation of Use” regarding age-related hypogonadism.
“Testosterone isn't meant to be a lifestyle supplement-type drug, but it's meant to be used in certain indications, and so it's always good and appropriate to maintain indications like that. Now, the specific terms they use, you could argue that the data may or may not support that. There's debate, for example, whether age is truly relevant and whether testosterone does continue to decline with aging. Again, the science is back and forth on that right now. So if anything, it may be a little bit too specific for what the data would support, but the concept of a targeted group who's appropriate for therapy is appropriate,” Trost commented.
