The U.S. Food and Drug Administration (FDA) has already warned about the risk of blood clots associated with polycythemia, a condition where a patient has abnormally high levels of red blood cells due to testosterone treatment. Now, the agency is strengthening this warning; recent reports show that blood clots in the veins, known as venous thromboembolism, have occurred without polycythemia.
The FDA stated that “Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products,”
Eli Lilly and Co. said it would update the label on its testosterone drug Axiron to reflect this new information, Law360 reports. AbbVie said it would also update the label for its topical testosterone Androgel.
The FDA is investigating whether or not testosterone drugs increase the risk of stroke, heart attack and death. The review began in January following two research studies showing that men who used testosterone replacement drugs had elevated cardiovascular risks. One study was published in the Journal of the American Medical Association (JAMA) in November. Researchers looked at thousands of patients and found that testosterone therapy was associated with a 30 percent increased risk; 26 percent of men using testosterone therapy had a heart attack, died or suffered a stroke compared to 20 percent in men who did not use testosterone products. In January, PLOS One published a study showing that the risk of heart attack doubled in men over 65 using testosterone replacement.