Washington, DC: In public announcement issued this week, the US Food and Drug Administration (FDA) states it is requiring manufacturers to include a general warning in the drug labeling of all testosterone products about the risk of blood clots in the veins.
The potential for venous blood clots is already included on labels for products as a possible consequence for the condition polycythemia, or an abnormal increase in the number of red blood cells, the agency announced Thursday.
As a result of increased reports of polycythemia, the FDA is requiring a change to “ensure this risk is described consistently” in all approved products.
Such products are approved for use in men who lack or have low testosterone levels associated with medical conditions, including genetic problems and chemotherapy.
The FDA adds that officials are continuing an evaluation of the possible risk of stroke, heart attack, and death in patients taking such drugs in relation to blood clots in patients’ arteries.
Agencies/Canadajournal
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