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Jun 26, 2014

Testosterone Products to Obtain Venous Blood Clot Warning


"Testosterone products must add a general label warning about the increased risk for venous blood clots, including deep vein thrombosis and pulmonary embolism." 

The 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 is separate from is ongoing investigation into testosterone being a factor in increased risk for stroke and heart attack.

The labels of testosterone products already caution consumers 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 that have no connection to polycythemia.   The agency, therefore, is making the warning more general.