The search for the fountain of youth among U.S. men, along with aggressive marketing practices on the part of testosterone manufacturers, has created which could well be the perfect storm. Recently, the Journal of American Medical Association published a study which concluded testosterone supplements could up the risk for heart attack, stroke and death. In fact, although testosterone supplements are, across the board, approved by the FDA only for the treatment of hypogonadism (a condition where the body stops producing testosterone), to treat endocrine tumors or for those undergoing chemotherapy, millions of men who are experiencing the natural effects of aging are begging their doctors for a prescription for testosterone. Men are getting the message that if they are seeing a decrease in energy, a loss of libido, erectile dysfunction, loss of muscle mass, bone density or strength, or an increase in belly fat, they should be taking testosterone supplements. In fact, these are all the natural effects of aging, and have nothing to do with the medical condition of hypogonadism.
Bio-T-Gel Recently Approved by the FDA
Bio-T-Gel is a testosterone gel manufactured by Teva Pharmaceutical, and approved by the FDA in February, 2012 as a treatment for hypogonadism. The recommended dosage of Bio-T-Gel is 50 mg. applied topically once daily, in the mornings. The FDA approved Bio-T-Gel based on a 180-day trial among 227 men with diagnosed hypogonadism—a condition in which the body fails to produce sufficient testosterone. This is not the same thing as the naturally declining levels of testosterone experienced by all men as they age.
In fact, after men reach the age of 30, they will begin to see a decrease of 1-3% in testosterone levels each year. Although Bio-T-Gel is a relative latecomer in the testosterone supplement race, they are nonetheless grabbing a share of the $2 billion in annual testosterone sales. The insert which accompanies Bio-T-Gel cautions those with breast or prostate cancer, urinary problems, heart, liver or kidney problems, sleep apnea or other medical conditions to speak with their healthcare provider prior to using the testosterone supplement.
Lack of Research Regarding Testosterone Therapy
Unlike the massive levels of studies done regarding hormone replacement therapy for women, there is little research regarding testosterone therapy for men. The JAMA study has prompted the FDA to caution doctors to conduct a thorough risk vs. benefit assessment on all men prior to prescribing a testosterone drug, and to state the agency will look into the potential risks of testosterone supplements.
It could be months—or years—before serious research can be conducted and a definitive conclusion reached, however in the interim, it appears many men are suffering injury or harm from a testosterone supplement. Five men recently filed suit against the manufacturer of Andro-Gel, claiming known risks were hidden from the public. Three of these men suffered heart attacks after they began testosterone therapy, one suffered a stroke, and the fifth a mini-stroke. In addition to heart attack, stroke and death, there is evidence that testosterone therapy can lead to pulmonary embolism and deep vein thrombosis. It is important to discuss any adverse health issues with your doctor, then it can be beneficial to speak to a well-qualified testosterone injury lawyer.