Testosterone Must Include General Warning for Blood Clots, Says FDA – ModVive

Testosterone is viewed by many aging men as a fountain of youth, a way to restore sexual function as well as improve muscle tone. However, the U.S. Food and Drug Administration has just announced an additional risk associated with the treatment – blood clots in the veins.

Blood clots in the veins, or venous thromboembolism (VTE), includes deep vein thrombosis and pulmonary embolism. The risks of blood clots associated with testosterone have established, however, the risk was previously associated with polycythemia – an abnormal increase in the number of red blood cells which sometimes occurs as a result of testosterone therapy. Now, due to reports of clots not associated with polycythemia, the FDA is calling for a change in the drug labeling to include a general warning about blood clots.

Testosterone is a hormone produced mainly in the testicles which helps to maintain, among other things, bone density, fat distribution, and sex drive. Testosterone levels gradually decrease over time, but sometimes, hormone levels can be low because of a medical condition called hypogonadism. There are two types of hypogonadism, primary and secondary.

Primary hypogonadism results from a problem with the testicles, while secondary hypogonadism is caused by a problem in the hypothalamus or the pituitary gland — parts of the brain which signal the production of testosterone in the testicles. Testosterone products are only FDA-approved for use in men who lack or have low testosterone levels along with an associated medical condition.

Blood clots are not the only risks associated with testosterone, other side effects include increased risk of heart attack, sleep apnea, and breast enlargement. The FDA had previously announced that it is investigating the risk of stroke, heart attack and death associated with testosterone.  That investigation is still underway, however, one has to start wondering if the benefits of testosterone therapy outweigh the risks. The FDA emphasizes that health care professionals should assess on an individual basis, whether the benefits of testosterone treatment is likely to exceed the potential risks of treatment.

Testosterone Must Include General Warning for Blood Clots, Says FDA – ModVive

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