Testosterone ("Low T") Therapy

Testosterone treatment for what is commonly called "low T" may be associated with serious, even fatal, complications. Many men have undergone this treatment to increase energy, help build muscle mass, increase sex drive, and improve bone density.

Symptoms of Low Testosterone

A decrease in testosterone is a natural process of aging. Typically, men will experience a decrease in testosterone levels beginning at around the age of 30. Low testosterone can cause a decrease in sexual desire and performance. Some studies suggest that more than half of men with low testosterone suffer from erectile dysfunction. There are other physical symptoms associated with low testosterone, including increased body fat, decrease in bone density and muscle mass, hot flashes, and swelling or pain in the breasts. In addition to the physical symptoms associated with low testosterone, there can also be emotional side effects. These include depression, memory problems, and a decrease in self-confidence. Many men with low testosterone also experience fatigue, insomnia and changes in sleeping patterns.

Dangerous Side Effects of Testosterone Therapy

A blood test can be administered in order to check for testosterone levels. For men over the age of 65, a normal level is considered to be in the range of 300-450 nanograms per deciliter. Thousands of men who have been diagnosed with low testosterone have chosen to receive testosterone replacement therapy. Some known side effects of testosterone replacement therapy are acne, sleep apnea, and an enlarged prostate. Unfortunately, in addition to these potential side effects, there are also more serious dangers associated with the use of "low T" therapy.

A study published in November 2013 in the Journal of the American Medical Association indicated that men who had undergone testosterone replacement therapy faced an increased risk of heart attack and other adverse cardiovascular outcomes. The study followed more than 8,700 men who received testosterone therapy for three years, and found that these men were at a significantly increased risk of suffering a heart attack or stroke compared to men who had not undergone testosterone therapy.

A second study, which was published in January of 2014, also found that men who received testosterone treatment were at an increased risk of suffering a heart attack. In fact, for men who were under the age of 65 and who had a prior history of heart disease, there was a two-fold to three-fold increased risk of heart attack during the first 90 days of beginning testosterone therapy.

On January 31, 2014, the U.S. Food and Drug Administration (F.D.A.) issued a safety alert stating that it was investigating the risk of stroke, heart attack, and death in men receiving testosterone therapy. The F.D.A. stated that it would announce its conclusions and recommendations once it had completed its evaluation. The F.D.A. safety alert also recommended that "health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment."

Different Types of Testosterone Replacement Therapy Products

It is estimated that more than 5 million prescriptions for testosterone therapy are written annually. The testosterone is administered as a patch, a gel, or an injection. The following products have been prescribed to treat "low T":

- Androgel (manufactured by AbbVie, which was formerly a part of Abbott Labs): Androgel is a gel that is applied to the skin on the shoulders or arms. Androgel was approved by the F.D.A. in 2000

- Androderm (manufactured by Actavis, Inc.): Androderm is administered by means of a patch that is placed on the back, arms, thighs or abdomen. Androderm was approved by the F.D.A. in 1995. It comes in either a 2 mg. or a 4 mg. strength.

- Axiron (manufactured by Eli Lilly and Company): Axiron was approved by the F.D.A. in 2010. It comes in the form of a topical solution which is applied underneath the armpits

- Bio-T Gel (manufactured by Teva Pharmaceuticals): Bio-T Gel is a topical gel that is applied once daily to the skin on the shoulders and upper arms. The dosage can be adjusted between a minimum of 50 milligrams to a maximum of 100 milligrams. Bio-T Gel was approved by the F.D.A. in 2012.

- Depo-Testosterone (manufactured by Pfizer): Depo-Testosterone is applied by means of an intramuscular injection. This product was introduced by Pfizer in 2003. Sun Pharmaceutical Industries was given approval from the F.D.A. in June of 2013 for a generic version of depo-testosterone.

- Fortesta (manufactured by Endo Pharmaceuticals, Inc.): Fortesta is a spray gel that is applied daily to the thighs. It was approved by the F.D.A. in 2010.

- Striant (manufactured by Columbia Laboratories): Striant is a tablet that adheres to the gums or inner cheek and slowly releases testosterone. Striant was approved by the F.D.A. in 2003.

- Testim (manufactured by Auxilium Pharmaceuticals, Inc.): Testim is a gel that is applied to the skin on the shoulders. It was approved by the F.D.A. in 2002.

- Testopel (manufactured by Auxilium Pharmaceuticals, Inc.): Testopel is a pellet that is implanted under the skin and releases testosterone over a 3 to 6 month period. It was approved by the F.D.A. in 2008.

Many critics believe that the pharmaceutical companies who manufacture testosterone replacement therapy products failed to adequately research the risks of serious side effects before marketing their products directly to consumers in advertisements that urged healthy men to seek treatment for symptoms and conditions that are simply a normal part of aging. The Mahoney Law Firm is currently investigating testosterone replacement therapy claims for men who have died, suffered a stroke, suffered a heart attack, or had blood clots in the lungs (pulmonary embolism) or in the deep veins of the legs (deep vein thrombosis). If you or a family member has been injured while taking testosterone supplements, contact The Mahoney Law Firm.