The U.S. Food and Drug Administration (FDA) has reversed course on a crucial health issue involving drug safety, this time, regarding testosterone therapy. Based on the findings of the TRAVERSE clinical trial as well as post-market ambulatory blood pressure (ABPM) studies, the FDA is making significant adjustments to the labeling of testosterone products and confirming what doctors who prescribe testosterone have been saying for a long time; the use of testosterone is not harmful for males with low testosterone levels. Prior FDA warnings were too prudent and misguided.
Key Labeling Changes: FDA Backtracks
The FDA is now requiring the following changes on testosterone product labels:
- In reviewing the TRAVERSE trial results, it was found that there was no increase in cardiovascular risk in the testosterone product labeling of all testosterone products.
- The retention of the “Limitation of Use” warning for hypogonadism related to age.
- The removal of Boxed Warning about an increased likelihood of adverse outcomes from cardiovascular disease.
Furthermore, ABPM study findings have been the basis for:
- Specific information for each product added to the list of the increased blood pressure of testosterone products that have been subjected to ABPM studies. The inclusion was made using the study that didn’t contain prescribers who were simultaneously monitoring estradiol or reducing its growth by using aromatase inhibitors which is a method utilized by millions of males who are on Testosterone Optimization Therapy.
- A new general warning regarding the increase in blood pressure associated with testosterone products previously not having the warning. This could be caused by higher levels of estradiol which were not monitored and treated. The typical testosterone prescriber across the United States would always monitor estradiol levels and, if this were conducted in this study this additional warning might be unnecessary.
The TRAVERSE Trial: What Practitioners Prescribing Testosterone Already Knew
For a long time, doctors who specialize in the field of testosterone treatment (TRT/TOT) have claimed that the FDA’s warnings of 2014 and 2015 regarding cardiovascular risks were based on faulty or inaccurate information. It was the TRAVERSE trial, launched in response to FDA’s demands for the conduct of safety studies across the entire industry that finally established the truth: the use of testosterone does have no effect on increasing the chance of suffering from heart strokes, heart attacks, or any other major cardiovascular event. Also, the FDA’s earlier fear-mongering was not based on fact, and those who needed testosterone therapy could be apprehensive in receiving treatment. What number of men could have protected their heart health by treating low testosterone levels in the absence of this warning being included on life changing testosterone treatment product labels?
FDA’s History of Getting It Wrong Consistently
The FDA’s blunders regarding testosterone safety are just the latest in the long line of retractions, overregulation and delayed course corrections. Many practitioners argue that the FDA frequently reacts with rash decisions, based on insufficient research, and then reverses them when real-world research proves the agency’s claims unfounded.
Meanwhile, doctors who have treated patients suffering from low testosterone levels have repeatedly noticed the advantages of TRT/TOT. Patients have noticed improvements in mood, energy, metabolism, muscle mass and overall health without the alarming cardiovascular risk that the FDA previously warned about. Medical professionals have faced the challenge of these unjustified restrictions for more than 10 years and the latest information shows that experienced physicians had the right idea throughout the process. If you think you may have low testosterone, you should consult a doctor who specializes in Testosterone Optimization Therapy (TOT).
The New FDA Warning Regarding Blood Pressure Concerns
Although it has finally admitted that testosterone is not a factor in increasing cardiovascular risk, the FDA is now focusing its attention on concerns regarding the increase in blood pressure that is in light of ABPM studies. While monitoring blood pressure is always prudent, many doctors are still doubtful that the issue is serious enough to warrant a new warning. Many critics argue that this could be another case that is a result of the FDA shifting its attention instead of admitting to its past mistakes.
What It Means for Patients and Physicians
Testosterone therapy remains a vital treatment for those suffering from hypogonadism, as well as a broad array of other associated comorbidities. These updates to the labeling should assure both patients and physicians that TOT is a safe treatment. However, the larger conclusion is clear; the FDA’s record of decision-making regarding safety for drugs isn’t close to perfect, and doctors must continue to rely on their clinical experiences and thorough research, not just reactionary regulatory decisions.
For more information, speak with a respected medical professional whose primary focus is centered around testosterone replacement and hormone replacement therapies, and stay up to date with the most recent research in testosterone treatment.
References:
https://www.nejm.org/doi/full/10.1056/NEJMoa2215025
https://wayback.archive-it.org/7993/20161022203711/http:/www.fda.gov/Drugs/DrugSafety/ucm436259.htm
