Which Testosterone Booster is Approved by the FDA?

The Food and Drug Administration (FDA) recently approved Jatenzo (testosterone undecanoate), an oral testosterone capsule, to treat men with certain forms of hypogonadism. Testosterone replacement therapy (TRT) offers a range of health benefits for older men who have signs and symptoms of low testosterone levels and documented low blood levels of the hormone. It is estimated that 2.4 million American men aged 40 to 69 suffer from this condition. Studies have shown that elevated testosterone levels are associated with increased sexual activity, sexual desire, and erectile function in men over 65. However, two faulty studies were included in the FDA decision to add a black label warning to testosterone treatment.

The other two studies in the review showed a statistically significant benefit with TRT, while the rest of the study was inconclusive. A study involving 1031 male veterans aged 40 and older found that those treated with testosterone experienced substantial benefits. The damage caused by years of potentially lower testosterone levels was not taken into account in the study and may have biased the results. It is clear that TRT offers compelling benefits when administered to men with genuine symptoms of age-related testosterone deficiency and documented low blood levels of the hormone.

The main analysis evaluated mortality in men with low serum testosterone levels compared to men with normal serum testosterone levels. The successful gel is prescribed as a TRT drug, mainly to men whose bodies do not produce sufficient amounts of the male hormone. Gels, injections, patches, creams, nasal gels, capsules, and tablets are all available as medications for TRT. Despite these proven benefits, the FDA recently ordered that a warning label in the form of a black box be placed on prescription drugs.

The revised labels clarify the approved uses of these drugs and include information on a possible increase in the risk of heart attacks and accidents. On the contrary, there seems to be a strong beneficial relationship between normal testosterone and cardiovascular health that has not yet been much appreciated.