The U.S. Food and Drug Administration (FDA)
recently announced they would be investigating the safety of testosterone drugs after two
studies indicated an increased risk of cardiovascular events among men
taking the hormone. The agency cautioned men from abandoning their drug
routine without consulting their physician first, and warned doctors to
follow prescribing recommendations carefully.
Testosterone is commonly referred to as the male sex hormone. It plays
many roles in men's health-from changes during puberty to sexual function
and even metabolism. It is responsible for masculine characteristics and
growth in men. Drugs like Androgel, Depo-Testosterone, and Axiron are
testosterone replacement drugs that can be applied through transdermal
patches, injections, and gels. All of these are included in the FDA investigation.
These drugs may be prescribed for men who have low testosterone for a variety
of reasons including those who no longer produce testosterone due to chemotherapy
or genetic problems. Problems with the pituitary or hypothalamus glands
could also lead to hormonal imbalance and result in a prescription for
Studies indicate potential risks
The FDA cited
two separate studies in their safety announcement. Both played a role in the FDA's decision
to investigate the drugs.
The first study was published in the
Journal of the American Medical Association (JAMA) in November 2013 and was an observational study of older men being
treated within the VA health system. The men included in the study all
had low serum testosterone. All of them underwent coronary angiography,
an imaging test of the vessels of the heart, to determine their risk for
coronary artery disease. While some of the men were on testosterone treatment,
others were not.
Among the men receiving testosterone treatment, there was a 30 percent
increased risk of heart attack, stroke, and death when compared with the
men who weren't on the hormone treatment.
In the second study, published more recently in the journal
PLOS One, researchers found an increased risk of heart attack among both older
and younger men with pre-existing heart disease on prescription testosterone
The study found men 65 and older had a doubled risk of heart attack in
the first 90 days of a prescription testosterone regimen. For the younger
study participants, the risk was increased two- to three-fold in the first
90 days. Among the younger participants
without pre-existing heart disease, there was no increased risk.
Are you taking testosterone?
The FDA warned patients on a testosterone regimen to speak with their physician
before changing anything about their dosage routine. It says that despite
the warnings about these drugs, men should not make a decision to stop
treatment without consulting their doctor first.
For doctors, the FDA warns these drugs are
only approved for use with men who have low testosterone levels in association
with a medical condition. Patients with low testosterone levels without
an associated medical condition are not to be treated with these drugs.
The FDA also says that physicians should weigh the benefits of the drugs
with the potential risks, knowing their patients heart histories and the
seriousness of their medical conditions.
The FDA did not indicate when their investigation would be complete.
Dangerous drugs are often not detected until after numerous patients have experienced
adverse health effects. In some cases, it seems patients end up being
the guinea pigs for the drug makers. Drug makers have a legal responsibility
to make and market drugs that are safe and effective when use as directed
and to provide adequate warnings of known risks associated with a prescription
drug. When they fail to fulfill their legal responsibility, they should
be held accountable.