The FDA announced that it is requiring a general warning in the drug labeling
for all approved testosterone products about the potential risk of venous
thromboembolism (VTE), or blood clots in the veins, which include deep
vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous
blood clots is already included in the drug labeling for testosterone
products as a potential consequence of polycythemia, an increase in the
number of red-blood cells that occasionally occurs with testosterone treatment.
However, postmarket reports of blood clots unrelated to polycythemia have
led the FDA to require a broader warning in the drug labeling to assure
that the risk is consistently described for all testosterone products.
This new warning of venous blood clots comes after the FDA announced months
ago that it would be investigating potential risk of heart attack, stroke,
and death in patients using testosterone products. These risks are associated
with blood clots in the arteries, and the evaluation is ongoing.
If you or a loved one has suffered an injury after using testosterone replacement
therapy, contact Morelli Law Firm immediately to learn more about
your rights. Call 888-396-4930 or fill out a FREE