The FDA announced it is requiring all prescription testosterone manufacturers to add general warnings for blood clots in the veins, known as venous thromboembolism (VTE), on their products’ labels.
The FDA said that this announcement is not related to its ongoing investigation into the risk of strokes, heart attacks and death in patients using prescription testosterone products; however, the attorneys at Morgan & Morgan continue to review claims on behalf of men who were injured after using these products.
In its safety communication, the FDA said that prescription testosterone products currently have warnings for two types of venous blood clots: deep vein thrombosis (DVT) and pulmonary embolism (PE); however, these warnings are only listed as possible consequences of polycythemia, an abnormal increase in the patient’s number of red blood cells following testosterone treatment.
When reviewing post-market reports from patients, though, the FDA said that there were several cases in which men using prescription testosterone products experienced venous blood clots that were not related to polycythemia. Therefore, the agency said that it would require label changes for these products to include a more general warning for blood clots.
Prescription testosterone manufacturers AbbVie Inc., which makes Androgel, and Eli Lily & Co., which makes Axiron, said that they are currently working on updating the labels for their products, according to reports.
The FDA’s announcement reiterated that prescription testosterone products have only been approved by the agency for use in men who lack or have low levels of testosterone due to an associated medical condition.