FYI – Testosterone Replacement Therapy and Testosterone Medication

As issues come up we try to make sure that our clients are kept informed about different cases that potentially might impact or involve them. These might include recalls, drug warnings, or other issues consumers need to be aware of.

Testosterone Replacement Therapy and Testosterone Medication

The U.S. Food and Drug Administration (FDA) has warned that prescription testosterone replacement therapy (TRT) products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.

FDA Warnings

The FDA now requires the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. They are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone.

Health care professionals have been warned that they should only prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.

What is Testosterone therapies

Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism. Examples of these disorders include failure of the testicles to produce testosterone because of genetic problems, or damage from chemotherapy or infection. However, FDA 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.

What are the dangers from TRT?

Studies have shown that there is a significant increase of risk to older men of having heart-related issue while they are taking TRT.  The study goes further and says that if there is a pre-existing heart condition that a man has an increased risk of heart-related issues.

Based on evidence from published studies and expert input from its Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.

“Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. The need for doctors to advise their patients of the potential dangers of testosterone therapy is serious. As well as manufacturers need to properly test these drugs in several trials and display the risks of taking these drugs on the packaging” (FDA, 2014).

Lawsuits over TRT

There has been some ongoing litigation in Federal Court in Illinois, Konrad v. Abbvie. Abbvie, the manufacturer of the popular TRT drug, Androgel MDL. Two doctors one formerly from the FDA, Dr. David Kessler, and the other a physician/scientist at the University of Northwestern, Dr. Ardehali, testified that Abbvie advertised the drug for people outside of its approved usage and failed to warn users of Androgel of the side effects including heart attacks, stroke, or pulmonary embolism.

Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as:

  • Chest pain
  • Shortness of breath or trouble breathing
  • Weakness in one part or one side of the body
  • Slurred speech


If you or a family member has experienced any of the symptoms of a stroke, heart attack, or any other cardiovascular disease due to testosterone replacement therapy for more information call us at Aaron Law Firm. We will help connect you with law firms who have experience handling these types of cases. Our phone number is (205) 685-8383.

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