fda

In this episode, Dr. Morgentaler and Dr. Brandon talk about the FDA finally reversing its stance on testosterone risks, what that means for heart health, and why it’s a big win for science—and for patients. Chapters 00:07 – FDA's New Stance on Testosterone In this episode, Dr. Morgentaler...

https://www.urologytimes.com/view/pearls-perspectives-helen-bernie-do-mph-at-aua-2025 In this episode of Pearls and Perspectives from Urology Times, host Amy Pearlman, MD, sits down with Helen Bernie, DO, MPH, at the American Urological Association's (AUA) 2025 Annual Meeting in Las Vegas for...

Mohit Khera, MD, MBA, MPH, Professor of Urology and F. Brantley Scott Chair of Urology, Baylor College of Medicine, Houston, Texas, discusses evolving understanding of testosterone therapy and cardiovascular risk. In this 13-minute presentation, Dr. Khera focuses on the pivotal TRAVERSE trial...

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...

* Our findings suggest that mood improvements following TTh initiation may occur progressively, with the most substantial reductions in depressive symptoms observed after 18 weeks post-TTh initiation. TIMING OF MOOD IMPROVEMENT POST TESTOSTERONE THERAPY INITIATION Christian Corsini*, Edoardo...

https://www.vumedi.com/video/hormonal-therapy-and-thrombosis-risk-with-testosterone/

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...

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...

* He added, “It is my hope that the AUA will, in short order, go back and change that statement, so that we now have guideline-based instructions to physicians that will say, you are now allowed to say to patients that testosterone therapy is not associated with major adverse cardiovascular...

https://www.medscape.com/viewarticle/physicians-welcome-testosterone-labeling-changes-2025a10006gq?form=fpf Marius Pharmaceuticals, which markets Kyzatrex (testosterone undecanoate) capsules, indicated further studies of testosterone could be coming. Shalin Shah, CEO of the company, said in a...

* 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...

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...

https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products [2/28/2025] Today, FDA informed sponsors of testosterone products about new labeling changes following the agency’s review of the findings from the Testosterone Replacement...

Recognizing the True Value of Testosterone Therapy in Health Care (2022) Abraham Morgentaler, * Abdulmaged Traish, Rajat S. Barua, Paresh Dandona, Sandeep Dhindsa, Mohit Khera, and Farid Saad Abstract There has been little recognition within the medical community of the health impact of...

https://grandroundsinurology.com/presentations-from-the-32nd-annual-international-prostate-cancer-update/#session2 SESSION 2: Androgen Society Presentations (2022)

With the fda cracking down on compounded products like hcg and Enclomiphene and possibly hormones, is it likely that they’ll restrict the use of trt in the next few years like they did with gh (ie Trt only for those less than 264ng/dl)? Will they treat trt clinics (most of them fly by night)...

https://www.fda.gov/advisory-committees/advisory-committee-calendar/june-8-2022-meeting-pharmacy-compounding-advisory-committee-meeting-announcement-06082022 Agenda The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The...

Most users here have a history of struggle that to a smaller or larger extent was helped by initiating hormone replacement therapy (HRT). Yup Thousands of users use this platform daily to ask questions and learn more about HRT. There are hundreds of successful stories here where people’s quality...

I already don't' see it any longer on Amazon, it looks like FDA is now trying to "regulating" it. Other website still carry it, it may be wise to stack up now. Here the article Amazon reportedly removes NAC-containing dietary supplements

Tlando is an oral form of testosterone undecanoate and failed to achieve high enough blood testosterone levels at the recommended dosage. The article says: The FDA has turned down Lipocine Inc.'s Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males...

Testosterone pellets have been placed on the "difficult to compound" list, preventing compounding pharmacies from manufacturing them. A petition to reconsider this decision was denied. If I read the decision correctly, it was because proper procedure for contesting the decision was not followed...

http://www.webmd.com/men/news/20161026/fda-warns-of-dangers-from-testosterone-supplements "FDA WARNS OF DANGERS FROM TESTOSTERONE SUPPLEMENTS" WebMD blares out No its not Tribulus, Horny Goat or Maca. In fact the latest fear mongering from the FDA isn't about any supplement at all don't...

I am considering going down the TRT and Trimix road, but I am concerned about compounding pharmacies and the safety of the products. I like researching things...so I found this: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm And also this...

Background information: FDA compounding enforcement draws ire from Congress The FDA is asking for comments now (Deadline July 18) Please add your comments to defend the compounding industry before the FDA imposes more restrictions. They are requesting comments now...

Testosterone and “Age-Related Hypogonadism” — FDA Concerns August 19, 2015 Nguyen CP, Hirsch MS, Moeny D, Kaul S, Mohamoud M, et al. Testosterone and “Age-Related Hypogonadism” FDA Concerns. New England Journal of Medicine. 2015;373(8):689-91...

Note: This information only covers prescriptions paid by insurance. It does not include prescriptions from cash-basis clinics. FDA's analysis of drug utilization data for testosterone replacement therapy (TRT) over the past 5 years shows a significant increase in the use of testosterone...

As of September 17, 2014 (last FDA meeting to review requirements for testosterone studies and products), approval of testosterone replacement products has become a lot more difficult in the United States. This was fueled by two flawed studies that linked testosterone to cardiovascular risks and...

The FDA has caught several supplement companies adding medications to their weight loss supplements. Be aware that this industry is not regulated and that the FDA only does spot checks once in a while. The FDA Found Hundreds of Supplement Brands Tainted with Rx Drugs. Most Weren't Recalled.

The U.S. Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The FDA and the U.S. Customs and Border Protection (CBP) also conducted...