Months after warning that testosterone treatments like AndroGel may cause heart attacks, strokes or death, the U.S. Food & Drug Administration (FDA) has issued yet another warning about the controversial class of medications. According to a June 20th posting on the agency’s website, the manufacturers of testosterone replacement medications have been ordered to add new warnings to their labels regarding an increased risk of venous blood clots, including deep vein thrombosis and pulmonary embolism.
Venous blood clots are those that occur in veins. Deep vein thrombosis develops in the veins located in the legs, while a pulmonary embolism is a potentially life-threatening clot that travels to the lungs.
The labels for testosterone medications already included information about a risk of such clots in relation to the development of polycythemia, a condition which occurs when there is a sudden increase in an individual’s red blood cell count. The new information now being added to the drug’s labelling is more general, and reflects post-market reports of venous clots, including pulmonary embolism and deep vein thrombosis, that occur in the absence of polycythemia among men using testosterone therapies.
The FDA noted in its June 20th alert that the new blood clot warning for testosterone replacement therapy was not related to the cardiac safety review it announced in January. That review was launched after two studies indicated that drugs like AndroGel increased the risk that certain men might be at an increased risk for heart attacks, strokes and death if they were undergoing low testosterone therapy. According to the FDA, its review of those possible testosterone side effects is ongoing.
Since the testosterone heart attack alert was issued in January, nearly 100 product liability lawsuits have been filed in U.S courts on behalf of men who allegedly suffered heart attacks, strokes, and blood clots due to the use of drugs like AndroGel. The majority of those claims are now pending in the U.S. District Court, Northern District of Illinois, where all federally-filed testosterone lawsuit claims have been consolidated for coordinated pretrial proceedings.