Some aging men might have perked up at the news that the U.S. Food
and Drug Administration (FDA) approved an oral testosterone treatment
for hypogonadism, or low gonadal testosterone production. After all,
with advertisements bombarding them with claims that attribute all of
their ills to “low T” and urge them to “ask their doctor” about it,
aging men might think it’s high time for a pill to pop instead of
dealing with a messy gel.Testosterone decanoate benefits
Unfortunately for them, the agency says that the newly approved drug,
Jatenzo (testosterone undecanoate; Clarus Therapeutics) isn’t for
age-related testosterone declines. Instead, it’s intended to treat
people who have hypogonadism because of less common causes, such as
tumors of the pituitary gland or Klinefelter’s syndrome. This form of
testosterone was previously approved as an injectable, Aveed (Pfizer).
The pituitary gland sends messages to the gonads that regulate
release of hormones, and tumors can turn the volume on these messages
inappropriately up or down . Klinefelter’s syndrome is the name given to
the suite of traits that result when someone carries a Y chromosome
along with two X chromosomes. One of the features of Klinefelter’s can
be smaller-than-average testes that produce low levels of testosterone.
Having this condition is associated with increased risks for obesity,
insulin resistance and mortality, which is related to why the FDA views
the benefits of Jatenzo as outweighing risks for this population.
The drawback of Jatenzo, the FDA said in a statement, is that as with
all testosterone treatments, risks increase for higher blood pressure,
which in turn is a risk for cardiovascular disease and death. For people
who have pituitary tumors or Klinefelter’s syndrome, it’s possible that
the benefits of the drug outweigh these risks. For older men
experiencing typical effects of aging, however, it is not, the FDA
concluded. About a third of men in older age might have hypogonadism.
The cardiovascular risk is sufficient that the drug label will carry a
boxed warning, as does Aveed, which is available only through the FDA’s
tightly controlled risk evaluation and mitigation strategy. The agency
urges that clinicians keep each individual patient’s cardiovascular risk
in mind and ensure that their blood pressure controlled when on the
drug. People with the conditions that are considered indications for
taking Jatenzo often are already using some other form of testosterone
(injection or skin patch), so their risk may not vary with a switch to
an oral pill. Almost 9 out of 10 of the 166 participants in the 4-month
trial of Jatenzo saw their testosterone levels rise to normal range
while taking the drug.