Patient Develops Blood Clotting From Testosterone Therapy

This case involves an overweight middle-aged male smoker with a history of hypogonadism who was prescribed testosterone medication. 7 months later, the patient developed swelling and tenderness in his extremities. He presented to the emergency room and was found to have deep vein thrombosis. Testing was done which showed he had developed a serious blood-clotting disorder due to a mutation of his blood protein. The patient later developed a pulmonary embolism and maintained consistent trouble breathing. An expert in hematology was sought to discuss the risk factors for clot development in males taking testosterone under these conditions.

Question(s) For Expert Witness

1. Please describe your background in hematology.

2. What are side-effects that have been observed with testosterone use in males?

3. What are risk factors for clot formation in males?

Expert Witness Response E-007690

I am a board-certified hematologist and professor of medicine and hematology at a large university medical center in the midwest. I have been practicing medicine for 40 years and I have lectured on factor V Leiden and the etiology of venous thrombosis. As part of my practice, I see men taking testosterone who have developed venous thrombosis and/or elevated hematocrit. Risk factors for clot formation in males include major surgery, cancer, and inherited coagulation abnormalities, such as factor V Leiden mutation. It is increasingly apparent that both obesity and sedentary behavior are also risk factors. Polycythemia, increase red blood cell, is also a risk factor to especially in the gene mutation which causes polycythemia vera. A recent study shows the risk of venous thrombosis with testosterone use peaks in the first 6 months and drifts down after that. The research finds the risk increased with other risk factors were present but as far as I can tell they did not determine factor V Leiden status. Testosterone can raise the hematocrit (a source of referrals for hematologist) but it appears testosterone-associated clots can occur in the presence of a normal hematocrit.