The U.S. Food and Drug Administration (FDA) has once again reversed course on a major drug safety issue—this time, on testosterone therapy. In response to findings from the TRAVERSE clinical trial and post market ambulatory blood pressure (ABPM) studies, the FDA is making major changes to testosterone product labeling, which ultimately validate what prescribing doctors have been saying for years: testosterone therapy is safe for men with low testosterone, and previous FDA warnings were overly cautious and misleading.
Key Labeling Changes: FDA Backtracks
The FDA is now requiring the following updates to testosterone product labels:
- By reviewing the TRAVERSE trial results, which confirmed no increased cardiovascular risk, in all testosterone product labeling.
- Retaining of the “Limitation of Use” warning for age-related hypogonadism.
- Removal of the Boxed Warning about an increased risk of adverse cardiovascular outcomes.
Additionally, ABPM study findings have led to:
- Addition of product-specific information on increased blood pressure for testosterone products with completed ABPM studies. This inclusion was added using a study that did not have prescribers simultaneously monitoring estradiol, or mitigating its increase with aromatase inhibiting drugs, a protocol used by millions of men on Testosterone Optimization Therapy.
- A new general warning about increased blood pressure for testosterone products that previously lacked such a warning. This is potentially due to increased levels of estradiol that were not checked and treated. The average testosterone prescribing practitioner in the United States would always monitor estradiol and if that had been done in this study, this additional warning may have been unnecessary.
The TRAVERSE Trial: What Testosterone Prescribing Practitioners Already Knew
For years, physicians specializing in testosterone replacement therapy (TRT/TOT) have argued that the FDA’s 2014 and 2015 warnings about cardiovascular risks were based on flawed or incomplete data. The TRAVERSE trial, initiated in response to the FDA’s insistence on industry-wide safety studies, finally provided definitive evidence: testosterone therapy does not increase the risk of heart attacks, strokes, or other major cardiovascular events. In other words, the FDA’s previous fear-mongering was unfounded, and patients who needed testosterone therapy may have been unnecessarily scared away from treatment. How many men could have protected their cardiac health, by treating their low testosterone, if this warning had not been added to these life changing testosterone drugs?
FDA’s Track Record of Consistently Getting It Wrong
The FDA’s missteps on testosterone safety are just the latest in a long history of overregulation, retractions, and delayed course corrections. Many physicians argue that the agency frequently makes reactionary decisions based on incomplete data, later reversing them after real-world studies prove their concerns unwarranted.
Meanwhile, doctors who have actually treated patients with low testosterone have consistently seen the benefits of TRT/TOT. Patients have seen improvements in energy, mood, metabolism, muscle mass, and overall health, without the exaggerated cardiovascular risks the FDA once warned about. The medical community has had to battle against these unnecessary restrictions for over a decade, and this latest update proves that experienced practitioners were right all along. If you suspect you have low testosterone you need to go to a practitioner who specializes in Testosterone Optimization Therapy (TOT).
Blood Pressure Concerns: A New FDA Warning
Despite finally admitting that testosterone does not increase cardiovascular risk, the FDA is now emphasizing concerns about increased blood pressure based on ABPM studies. While blood pressure monitoring is always prudent, many doctors remain skeptical that this concern is significant enough to warrant new warnings. Critics argue this may be yet another instance of the FDA shifting its focus rather than fully admitting its previous mistakes.
What Does This Mean for Patients and Doctors
Testosterone therapy remains an essential treatment for men diagnosed with hypogonadism and a broad array of other associated comorbidities. These labeling updates should reassure both doctors and patients that TOT is safe. However, the broader lesson here is clear: the FDA’s track record on drug safety decisions is far from perfect, and physicians should continue to rely on clinical experience and comprehensive research rather than reactionary regulatory decisions.
For more information, consult with a trusted medical professional who’s primary practice is focused on testosterone and hormone replacement therapies and stay informed about the latest research on testosterone therapy.
https://www.nejm.org/doi/full/10.1056/NEJMoa2215025
https://wayback.archive-it.org/7993/20161022203711/http:/www.fda.gov/Drugs/DrugSafety/ucm436259.htm
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