hypogonadism; t-therapy; fda; cvd
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Label change for testosterone: Implications for urologists, prescribers, and patients
Key Takeaways The TRAVERSE trial showed testosterone therapy's MACE risk is non-inferior to placebo, reassuring prescribers and patients. Despite the updated labeling, caution is advised due to potential venous thromboembolic events, particularly pulmonary embolism. Experts anticipate guideline...- madman
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- hypogonadism; t-therapy; fda; cvd
- Replies: 1
- Forum: Testosterone and Men's Health Articles
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Landon Trost, MD, on the impact of the FDA labeling changes for testosterone products
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...- madman
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- hypogonadism; t-therapy; fda; cvd
- Replies: 2
- Forum: Testosterone and Men's Health Articles
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Helen L. Bernie, DO, MPH, on the FDA’s labeling changes for testosterone products
https://www.urologytimes.com/view/helen-l-bernie-do-mph-on-the-fda-s-labeling-changes-for-testosterone-products "I'm so excited about them finally removing this boxed warning," says Helen L. Bernie, DO, MPH. The FDA’s recent announcement of class-wide labeling changes for testosterone...- madman
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- hypogonadism; t-therapy; fda; cvd
- Replies: 0
- Forum: Testosterone and Men's Health Articles
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The Androgen Society Endorses FDA's Class-Wide Labeling Changes for Testosterone Products
* It is important to note that long-term studies including TRAVERSE, T4DM, and T-Trials have not demonstrated blood pressure increases at periods of one year or greater. The Androgen Society acknowledges that these findings warrant careful consideration in the implementation of blood...- madman
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- hypogonadism; t-therapy; fda; cvd
- Replies: 2
- Forum: Testosterone and Men's Health Articles
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Marius Pharmaceuticals Helps Drive FDA’s Landmark Testosterone Label Update, Removing Black Box Warning
https://www.globenewswire.com/news-release/2025/03/03/3035638/0/en/Marius-Pharmaceuticals-Helps-Drive-FDA-s-Landmark-Testosterone-Label-Update-Removing-Black-Box-Warning.html RALEIGH, N.C., March 03, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, is pleased to announce that the U.S. Food and...- madman
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- hypogonadism; t-therapy; fda; cvd
- Replies: 1
- Forum: Testosterone and Men's Health Articles
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