On January 31 2014, the FDA issued a safety warning on the off-label use of testosterone in men, due to old age and required a labeling change to warn for the use of testosterone, due to an increased cardiovascular- and stroke risk.
The wording of that announcement included the following lines: link here
Testosterone is FDA-approved as replacement therapy only for men, who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.
In addition, based on the available evidence from published studies and expert input from an Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.
That "advice" was dissappointing since several studies published before the warning had already shown a positive correlation to reduced risk for cardio events after therapy and subsequently even in August 2015 a very large study by the Veterans Administration concluded that successfull hormone replacement therapy has a very positive impact on cardiavascular outcomes for the patients involved-
The Study Conclusion:
A Veterans Affairs database study of more than 83,000 patients found that men whose low testosterone was restored to normal through gels, patches, or injections had a lower risk of heart attack, stroke, or death from any cause, versus similar men who were not treated.
A very important study in my mind, which was recently reported upon, clearly indicates, that patients with current heart issues AND low testosterone, incur MUCH LESS major adverse cardiac events (MACE) than untreated patients, so it appears that hormone replacement therapy has a strong cardiac protective impact which is vital to be aware of.
The study from the Intermountain Medical Center Heart Institute in Salt Lake City :
A new multi-year study shows that testosterone therapy helped elderly men with low testosterone levels and pre-existing coronary artery disease reduce their risks of major adverse cardiovascular events -- including strokes, heart attacks, and death.
The study showed that patients who received testosterone as part of their follow-up treatment fared much better than patients who didn't. Non-testosterone-therapy patients were 80 percent more likely to suffer an adverse event.
"The study shows that using testosterone replacement therapy to increase testosterone to normal levels in androgen-deficient men doesn't increase their risk of a serious heart attack or stroke," said cardiologist Brent Muhlestein, MD, co-director of cardiovascular research at the Intermountain Medical Center Heart Institute. "That was the case even in the highest-risk men -- those with known pre-existing heart disease."
The research team studied 755 male patients at Intermountain Healthcare hospitals. The men were between the ages of 58 and 78, and all had severe coronary artery disease. They were split into three different groups, which received varied doses of testosterone administered either by injection or gel.
- After one year, 64 patients who weren't taking testosterone supplements suffered major adverse cardiovascular events, while only 12 who were taking medium doses of testosterone and nine who were taking high doses did.
- After three years, 125 non-testosterone-therapy patients suffered major adverse cardiovascular events, while only 38 medium-dose and 22 high-dose patients did.
"Although this study indicates that hypo-androgenic men with coronary artery disease might actually be protected by testosterone replacement, this is an observational study that doesn't provide enough evidence to justify changing treatment recommendations," Dr. Muhlestein said. "It does, however, substantiate the need for a randomized clinical trial that can confirm or refute the results of this study."
The new Intermountain Medical Center Heart Institute study corroborates the findings of a 2015 Intermountain study, which found that taking supplemental testosterone didn't increase the risk of experiencing a heart attack or stroke for men who had low testosterone levels and no prior history of heart disease.
Both Intermountain Healthcare studies address a recent mandate by the U.S. Food and Drug Administration. Last year, the FDA required manufacturers of all approved testosterone products to add labels outlining the coronary risks of the testosterone supplementation.
"The FDA's warning was based on the best clinical information available at the time," Dr. Muhlestein said. "As further information, like our research, becomes available -- and especially after a large randomized clinical outcomes trial can be accomplished -- hopefully the FDA will be able to change its warning."