The U.S. Food and Drug Administration (FDA) announced that it will strengthen the label on testosterone treatments to warn about the risks of developing blood clots. Testosterone treatments have been associated with a number of cardiological problems among patients who use it.
“It’s a truly tragic thing to see,” commented Brandon Bogle, an attorney with the Levin, Papantonio law firm who practices in the areas of personal injury and bad drug litigation. “Pharmaceutical companies will take something as natural as aging and try to turn it into an illness for which they’re have a ‘cure’ to sell you.”
According to the FDA, “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.” Commonly, blood clots associated with testosterone treatments occurred because of polycythemia, which is where the patient’s body produces an abnormally increased amount of blood cells because of treatment.
The FDA’s new orders to make a stronger label will affect all the companies that produce testosterone treatments, including AbbVie Inc., maker of the topical testosterone treatment AndroGel.
AbbVie, and other makers of testosterone treatments, have seen some legal hardships as the testosterone treatments produced and sold by these companies have been linked to some serious cardiovascular problems in patients. Studies have linked these treatments to an increased risk of heart attack, stroke, and even death.
In light of the findings of outside research groups, the FDA is investigating the apparent risks associated with using topical testosterone treatments, like AndroGel, Fortesta, and Tested.