Testosterone therapy, or "low T," products such as AndroGel are prescribed for men who may have a below-normal testosterone
level. These products are typically available in the form of skin patches,
mouth patches, gels and injections.
The manufacturers of these drugs tend to promise men who have low testosterone
that they will have more energy, experience better moods and regain the
vitality of their youth.
However, recent studies indicate that potentially fatal stroke and heart
attack risks may be associated with testosterone therapy.
One study, published in the journal
PLoS ONE and funded by the National Institutes of Health, found that men ages 65
and older could double their risk of heart attack after using a low T
product for at least 90 days. The risk tripled among younger men with
known heart disease.
A 2013 study found in the
Journal of the American Medical Association (JAMA) found an increase of 30 percent in the risk of heart attack, stroke
and death in men using testosterone therapy when compared to those who were not.
As these studies make clear, it is crucial for consumer safety that the
potential risks of these "low T" products be fully examined
and disseminated to the public.
FDA Trials Will Examine Risks of 'Low T' Therapy
Earlier this year, the
U.S. Food and Drug Administration (FDA) announced that it would evaluate the risks of heart attack, stroke and
death in men taking FDA-approved testosterone drugs. In its announcement,
the agency cited the two above studies and recommended that men concerned
about the risks discuss the issue with their doctors.
The FDA said that it had not reached a conclusion that low testosterone
products raise the risk of strokes and heart attacks and, for now, would
not order a label change.
However, some consumer rights advocates such as
Public Citizen have asked the FDA to wait no longer and require a "black box"
warning about these risks - the strongest warning possible.
Additionally, a $50 million series of trials is being led by Dr. Peter
J. Snyder of the University of Pennsylvania School of Medicine. The trials
will analyze testosterone therapy in men ages 65 and older with documented
"low T" levels, according to The New York Times.
However, information from the trials could be limited.
The Philadelphia Inquirer reports that the trials will cover only 788 men on the hormone or a placebo
for a one-year period. The study will detect benefits but not risks associated
with "low T" products, the newspaper said.
With nearly 3 percent of men over the age of 40 taking testosterone drugs
in 2011, and likely far more today, determining the true risks of these
medications should be a top priority.
At the very least, men who have been prescribed these drugs need to know
if they have been exposed to
dangerous drugs, and men who are considering taking these "low T" drugs deserve
to be fully informed of both the benefits and the risks they face.
Contact The Maher Law Firm today to discuss your legal rights and if you
may have a