Testosterone Replacement Therapy (TRT)

Testosterone Replacement Therapy is skyrocketing in popularity.

Drug manufacturers continue to roll out marketing campaigns advertising testosterone injections, gels, creams and patches aimed at men with “low T.” Claimed benefits range from better sexual performance, to increased energy and mental alertness.

But with the dismal track record of drug manufacturers surpassed only by the ineptness of the Food & Drug Administration, it should come as no surprise that serious safety concerns are being ignored. The Massachusetts injury attorneys at Jeffrey Glassman Injury Lawyers are dedicated to fighting for the rights of patients harmed by dangerous pharmaceuticals or defective medical devices.

Scientific evidence is emerging that men taking testosterone replacement have more heart attacks and are at increased risk of stroke, cardiovascular problems and heart disease. In fact, results of several studies in 2013 and 2014 suggest men double their risks of a heart attack in the 90 days after beginning a testosterone replacement regiment. As far back as 2010, the New England Journal of Medicine reported a clinical trial of testosterone gel was halted after an increase in heart attacks and other heart problems.

Testosterone may also stimulate the growth of prostate cancer cells.

The FDA has only approved TRT therapy for men who have low levels of testosterone caused by medical conditions that limit testicular production of the hormone. Yet drug manufactures continue to push treatment for an array of questionable conditions, essentially marketing TRT as a fountain of youth for middle-aged men.

Normal testosterone levels range from 300 to 1200 ng/dl (nanograms per deciliter) and decline with age. Men over 40 commonly test near 300 ng/dl, which may prompt treatment providers to double or even triple the amount of testosterone in the bloodstream, while still technically keeping a patient within “normal” limits.

Common side effects of TRT therapy include reduced liver and renal function, acne, breast enlargement, depression, nervousness, paranoia, difficult urination and mood swings.

In January 2014, the FDA announced it is re-evaluating the safety risks of TRT therapy after separate studies suggested a significant increase in the risk of cardiovascular events. While the government stopped short of agreeing with those assessments, the FDA urged doctors to evaluate whether potential treatment benefits outweigh the risks, particularly in those with cardiovascular disease or a family history of heart problems.

• Topical gels and creams:
• AbbVie, formerly the research-pharmaceutical arm of giant Abbott Labs, has won FDA approval for AndroGel, available in doses of 40.5 mg or 20.25 mg of testosterone. The gel is available by prescription for home use.
• Testim: Manufactured GlaxoSmithKline. Available in 5.0g containing 50 mg testosterone.
• Axiron: Manufactured by Eli Lily. Alcohol-based 30mg testosterone solution designed for underarm application.
• Men’s Health clinics continue to sprout up in city’s nationwide, offering prescriptions or onsite injections of testosterone cypionate, testosterone enanthate or testosterone propionate.
• Transdermal testosterone: Approved testosterone patches available in the United States include Androderm (manufactured by Actavis) and Testoderm (Various manufacturers).

While the FDA notes TRT therapy is not approved for men with low-T who do not have an associated medical condition, Men’s Health clinics and other questionable operators continue to prescribe testosterone as part of an anti-aging protocol. If you or someone you love has suffered heart problems while undergoing testosterone replacement therapy, contact Jeffrey Glassman Injury Lawyers for a free and confidential consultation to discuss your rights.

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