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FDA orders testosterone booster companies to conduct safety trial

December 2nd, 2015

The U.S. Food and Drug Administration is requiring manufacturers of testosterone boosters to conduct a large clinical trial to determine the true risks of the products. Testosterone boosters used to treat low testosterone have come under fire for their link to an increased risk of heart problems, along with a fear that they are being over-prescribed.

Researchers noted that unlike hormone replacement therapy for women, hormone therapy for men did not have a reliable source of clinical information. In 2010, the Women’s Health Initiative study found that hormone therapy in women increased risks of heart attacks, stroke, blood clots and breast cancer.

Prescriptions of testosterone boosters have triple since 2000, making the products a multi-billion dollar industry. Many researchers have shared concerns that patients are receiving testosterone treatments without first being properly diagnosed with low testosterone. Many testosterone booster manufacturers target aging men, citing common factors of aging such as fatigue and low libido as a need for testosterone therapy.


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