Testosterone Products to Get Venous Blood Clot Warning

June 20, 2014

The US Food and Drug Administration (FDA) announced yesterday that manufacturers of testosterone products must add a general label warning about the increased risk for venous blood clots, including deep vein thrombosis and pulmonary embolism.

The new warning is the latest twist in the ongoing debate about the possible cardiovascular harm posed by testosterone, which is indicated for men with low levels related to another medical condition. However, the FDA said that the warning about venous blood clots has nothing to do with its ongoing investigation into testosterone possibly increasing the risk for stroke and heart attack.

The labels of testosterone products already caution about the risk for venous blood clots as a result of polycythemia, a burgeoning of red blood cells sometimes associated with the therapy. However, the FDA has received postmarket reports of venous blood clots with no connection to polycythemia. Therefore, the agency is making the warning more general, it said.

More information about the announcement is available on the FDA Web site.

On June 16, the FDA also added testosterone to its FDA Adverse Event Reporting System (FAERS) database because it had received reports suggesting the possibility of abuse, misuse, or dependence.

To report problems with testosterone products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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