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The Issues Surrounding Testosterone Replacement Drugs

By Andrew Sullo


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While testosterone drugs have been approved by the FDA for the treatment of men who have been diagnosed with low testosterone levels, these drugs have recently been linked to serious side effects, including testosterone death. Over 432 million prescriptions for testosterone treatment drugs, including refills, were sold in the United States in 2013, up from 208 million in 2008. Between 2000 and 2011, the number of annual prescriptions for testosterone increased five-fold, and the market share of testosterone in 2011 was $1.6 billion dollars. Testosterone is a steroid sex hormone which the body produces naturally through a complex biochemical process. The peak level of male testosterone secretion is at the age of 18, and this level remains fairly stable through the age of 30-35. At this point, the levels of testosterone in males will begin declining by 1-3% per year.



Aggressive Marketing of Testosterone Drugs

Many feel this increase in testosterone drug sales is due to aggressive manufacturer advertising—if you watch much television you have likely heard advertisements for testosterone drugs. Prior to a study published in the Journal of the American Medical Association in November, 2013, which detailed certain risks of testosterone drugs, many physicians were prescribing testosterone treatments off-label to combat the natural decline in testosterone which occurs as men age. While doctors can legitimately prescribe drugs for off-label use, it is illegal for manufacturers to market drugs for off-label use. Even so, some testosterone manufacturers aggressively market their testosterone drugs by telling men that many of the natural symptoms of aging (falling asleep before bedtime, lower energy, low libido) can be alleviated with a prescription for testosterone. Perhaps even more disturbing is the number of younger men taking a testosterone drug for physical enhancement purposes. Most reputable physicians would agree that taking a testosterone simply to hold back the aging process is extremely ill-advised.

Testosterone Issues and Problems

Many doctors were unaware of the risks involved with testosterone supplements prior to the study, which concluded that the risks for testosterone treatment exceed the benefits in most men, despite the fact that testosterone treatment can increase lean muscle mass, a man’s overall strength, bone density and sexual functions. In a study of over 3,000 men—most at least sixty years old—it was determined that almost one-third of the participants were more likely to have a heart attack or stroke, or to die, than men in the same age group with low testosterone who did not take testosterone drugs. Even those men who began the study with unobstructed coronary arteries ended the study with a significant risk of coronary artery disease. The Mayo Clinic reported that men who had not been legitimately diagnosed with low testosterone yet took the drug were at risk for polycythemia (an overproduction of red bood cells which thickens the blood and leads to blood clots) and pulmonary emboli (blood clots in the leg veins which travel to the lungs). One study on the effects of testosterone replacement therapy drug issues on men with low levels of testosterone was halted in 2009, due to the high rate of heart attacks which were occurring among the participants. As expected—and just as with many other drugs and medical devices—research funded by the very pharmaceutical companies marketing the testosterone drugs have found no increased risk of adverse cardiovascular events among men taking the testosterone drugs. Most research, however, shows that men who have not had a valid diagnosis of low testosterone product yet take these testosterone drugs can suffer potentially severe cardiovascular and metabolic health issues, high cholesterol, diabetes, an increased risk of prostate cancer and plaque buildup leading to arterial blockages. Other known side effects of testosterone drugs include liver cancer, liver enzyme abnormalities, reduction in sperm count and infertility, prostate enlargement and difficulty with urination. Women who come in contact with a man who is taking a testosterone drug may experience masculinization effects including reduction in breast size, menstrual abnormalities, body hair and a deepening voice.

Have You Been Harmed By a Testosterone Replacement Therapy Drug?

Testosterone therapy can be delivered by gel, cream, patch, pill, injection or implant; some of the brands currently being prescribed include: Androgel, Androderm, Axirom, Bio-T-Gel, Delatestryl, Depo-Testosterone, Foresta, Striant, Testim and Testopel. The drug companies marketing these testosterone drugs include Pfizer, Endo Pharmaceuticals, Columbia Laboratories, Auxilium and Slate Pharmaceuticals. The FDA is currently investigating the risk of stroke, heart attack and death in men taking testosterone products, however the agency has yet to reach a conclusion. A number of lawsuits have been filed for wrongful death and for adverse health risks and injury due to the use of testosterone products. If you or a loved one has experienced injury due to the use of a testosterone product, it could be beneficial for you to speak to a knowledgeable Sullo & Sullo attorney. Our attorneys have the necessary experience and information necessary to ensure that your rights are protected as well as compassion for your situation. Don’t wait—call a Sullo & Sullo attorney today.

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