Testosterone Replacement Therapy

Testosterone replacement therapy is prescribed to treat low testosterone, otherwise known as hypogonadism. This condition occurs when the body fails to make enough hormones due to a problem with the testicles or pituitary gland.

Recently, testosterone replacement has become popular in treating decreased testosterone due to aging (or “Low-T”). Even younger men have begun taking the drug for physical enhancement. Studies have shown that approximately 43 percent the men being prescribed testosterone replacement therapy do not suffer from decreased levels of testosterone and are merely taking it to combat natural signs of aging, muscle loss, decreased bone density and decreased libido.

Testosterone replacement therapy has been linked to serious side-effects and long-term risks, including stroke, heart attack, congestive heart failure and even death.

Pharmaceutical companies began to market testosterone replacement for healthy older men with no history of hypogonadism. This use of the drug exposed healthy patients to unnecessary risks, and pharmaceutical companies could face complaints of misleading statements about the benefits of the drug.

Androgel, made by AbbVie and Abbot Laboratories, makes up from 50-60 percent of the market, but other testosterone replacement therapy manufacturers include:

  • Axiron – manufactured by Lilly USA
  • Androderm – manufactured by Actavis
  • Bio-T-Gel – manufactured by Bio Sante Pharmaceuticals and Teva Pharmaceuticals
  • Delatestryl – manufactured by Indevus Pharmaceuticals
  • Fortesta – manufactured by Endo Pharmaceuticals
  • Striant – manufactured by Mipharm S.p.A. and Columbia Laboratories
  • Depo–Testosterone – manufactured by Pfizer
  • Testim – manufactured by Auxilium Pharmaceuticals and Glaxo Smith Kline
  • Testopel – manufactured by Auxilium Pharmaceuticals

A study conducted by the National Cancer Institute analyzed 56,000 patients and found that men over the age of 65, as well as younger patients with a history of heart disease had twice the rate of heart attacks within three months of beginning testosterone replacement therapy. The study compared the men taking testosterone to men taking erectile dysfunction medications, such as Viagra and Cialis. The men taking Viagra and Cialis did not experience more heart attacks like the men on testosterone replacement.

The Journal of American Medical Association (JAMA) also published a study with similar results. This study found that older men suffered an increase in stroke, heart attack and death at a rate of 29% when they were taking testosterone replacement therapy.

A federally-funded study conducted in 2009 tried to determine whether testosterone gel could help older men build muscle, but the study was discontinued when some of the participants suffered from heart attacks and other cardiac issues.

In March 2015, the FDA announced that all testosterone replacement therapies must update their labels to include the increased risk of heart attack and stroke. The FDA also stated that the testosterone replacement therapies had been overprescribed to men who were suffering from low hormone levels because of aging and not as a result of hypogonadism or another medical issue. In this announcement, doctors were warned to only prescribe the treatments for the approved uses, in order to prevent unnecessary side-effects.

As of July of 2015, over 2,000 lawsuits regarding testosterone replacement therapies have been filed.

The deadline for filing lawsuits for the side effects of testosterone replacement therapy, based upon the applicable statutes of limitations will soon be approaching. If you or someone you know has suffered cardiac problems, such as a stroke, heart attack, congestive heart failure or death after taking testosterone, you should contact the experienced Mass Tort and Product Liability Litigation network of attorneys at Jacoby & Meyers for a free case evaluation.

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