The U.S. Food and Drug Administration (FDA) recently issued a warning regarding
drugs used to treat low testosterone in men. The agency warns that the
increasingly popular medications come with serious risks and now requires
drug makers to add specific warnings to their labels.
In response to aggressive marketing campaigns, prescriptions for testosterone
replacement drugs grew fivefold between 2000 and 2011. An estimated 1.5
million men have been prescribed medication to treat low testosterone
or low-T, according to the
Los Angeles Times. Most concerning, many men (25 percent) never had their testosterone levels
checked prior to starting the medication.
In response to concerns over the use of testosterone drugs, the
FDA recently issued a new safety alert. It states that the agency 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.”
Accordingly, the FDA is requiring that drug manufacturers change their
labeling to clarify that prescription testosterone products are approved
only for men who have low testosterone levels caused by certain medical
The FDA alert also highlights that the risks of testosterone products are
not yet fully understood. Studies have found that they can increase the
risk of stroke, heart attack and even death.
As we previously discussed on this San Diego Injury Blog, one study found
an increased risk of heart attack in older men, as well as in younger
men with pre-existing heart disease. Researchers reported a twofold increase
in the risk of heart attack among men aged 65 years and older in the first
90 days following the first testosterone prescription.
To help patients fully understand the risks, drug labels must also disclose
a possible increased risk of heart attacks and strokes in patients taking
testosterone. The FDA is also advising health care professionals to consider
whether the benefits of testosterone treatment are likely to exceed the