FDA Adds CVD Warning to Testosterone Replacement

Prescription testosterone product labels must now include warnings about the possible increased risk of heart attacks and strokes, says FDA.
Prescription testosterone product labels must now include warnings about the possible increased risk of heart attacks and strokes, says FDA.

The Food and Drug Administration (FDA) announced that prescription testosterone product labels must be changed to clarify the approved use of these medications and information on the possible increased risk of heart attacks and strokes in patients taking testosterone must also be added.

Testosterone is an FDA-approved replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause hypogonadism. The FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no reasons other than aging. The safety and efficacy of this use of testosterone has not been established.

After reviewing evidence from published research and expert input from an Advisory Committee meeting, the FDA has concluded that there is a potential increased cardiovascular risk linked with testosterone use; some studies indicated an increased risk of heart attack, stroke, or death associated with testosterone treatment, although others did not. 

All prescription testosterone products must now update their labels to include information on the possible increased risk of heart attacks and strokes. Manufacturers of approved testosterone products must also conduct a well-designed clinical trial to further examine this risk.

The FDA is advising that healthcare professionals who prescribe testosterone replacement therapy follow these recommendations:

  • Before initiating testosterone replacement therapy, ensure that the diagnosis of hypogonadism has been confirmed with laboratory testing. Verify that serum testosterone concentrations have been measured on at least two separate mornings and are consistently below the normal range. Avoid measuring testosterone concentrations later in the day, when measurements can be low even in men who do not have hypogonadism.
  • For each patient, weigh the potential increased risk of major adverse cardiovascular outcomes and other risks of testosterone replacement therapy against the potential benefits of treating hypogonadism.
  • Inform patients of the potential increased cardiovascular risk associated with testosterone replacement therapy.
  • Encourage patients to read the patient Medication Guide or patient information leaflet they receive with their testosterone prescriptions.
  • Report adverse events involving testosterone treatment to the FDA MedWatch program.
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