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Policy Blog: FDA Requires New Warning on Testosterone Products

June 2014

On Friday, June 20, the U.S. Food and Drug Administration announced that testosterone supplements must now carry a new warning label regarding an increased risk of blood clots, including conditions known as deep vein thrombosis (DVT) and pulmonary embolism. In February 2013, the FDA announced an investigation into whether or not the use of testosterone products raises the risk of heart attack and/or stroke. The June FDA announcement can be viewed here.

Q: Is this labeling change related to the safety communications that the FDA released on testosterone earlier this year?

The agency stated as part of its announcement that this new requirement is unrelated to the investigation publicized earlier this year. However, it is important to note that the risk of venous clots is already included in testosterone product labeling as a possible consequence of polycythemia (abnormal increase in the number of red blood cells), which sometimes occurs in patients treated with testosterone supplementation. The FDA has stated that post-market reports of venous blood clots unrelated to polycythemia led to the change in labeling.

Q: What is the AUA's position on testosterone?

The AUA has been actively following the national discussion about risks associated with the use of testosterone products since the FDA first announced its investigation earlier this year. We understand the FDA's concerns about safety. However, it is important to note that there are data that have demonstrated that supplemental testosterone can have a beneficial effect on cardiovascular risk. That said, as with any drug or supplement, there are both benefits and risks. It's our job as physicians to manage both the positives and negatives, and to work with individual patients to make the best decision as to whether or not hormone replacement therapy is appropriate.

Regarding the general topic of testosterone replacement therapy, the AUA has a full position statement that addresses diagnosis and management of testosterone deficiency and when supplements should be offered.

Q: What about patients who are already taking testosterone replacement therapy?

In light of this new information from the FDA, it's understandable that some patients taking testosterone supplements may have serious concerns about their own risk profile. At this time, the FDA is simply requiring a labeling change; no additional steps have been taken to restrict the use of testosterone in appropriate patients.

It is important to remember that testosterone replacement therapy requires active management and communication by both the physician and the patient, with active follow up and monitoring. Regular check-ups and tests to measure testosterone, prostate-specific antigen and hematocrit levels (as well as other patient-specific tests) are a key part of active management, and can help manage risks.

Additional Resources

AUA position statement on testosterone therapy.

Urology Care Foundation patient information sheet.


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