Testosterone Therapy – Risks & Dangers

Prior to 2015, as many as 2.9 percent of American men, over the age of 40, were using testosterone replacement therapy. Due to aggressive marketing techniques, the figure represented a four-fold increase in numbers between 2000 and 2014. Though drug companies are no longer marketing testosterone in the same way, many men may still be taking testosterone replacement products, putting them at significant risk for serious health risks.

Testosterone is an androgen or male sex hormone and is responsible for most of the male secondary sex characteristics like facial hair, low voice, muscle mass and sexual organ development. Testosterone replacement therapy, also known as androgen replacement therapy, has traditionally been used to treat male hypogonadism. With this condition, the body fails to make enough male hormones or androgens. In male hypogonadism, the testicles do not make enough androgens such as testosterone, either due to a pituitary problem or a testicular problem.

Testosterone replacement medications are approved to treat primary hypogonadism (congenital or acquired) which is caused by genetic defects or toxicities or conditions resulting in testicular failure such as chemotherapy, trauma, or injury. It is also approved to treat secondary hypogonadism (congenital or acquired) which is caused by a malfunction of the pituitary gland from due to genetic defects or due to tumors, trauma, or radiation. Testosterone replacement therapy is not approved to treat testosterone levels that have fallen as a result of the normal aging process.

Aggressive Testosterone Marketing

Many men who used testosterone therapy may not have needed the medication but did so because of aggressive marketing tactics. Drug companies undertook massive advertising campaigns to promote testosterone use for symptoms of “Low-T”. These advertisements encouraged men to ask their health providers about testosterone products that would help them with fatigue, decreased sex drive, loss of muscle tone and lack of energy.

Many of the men who received prescriptions for testosterone products, were never tested for low testosterone levels but were likely experiencing symptoms that only indicated normal aging. This may have placed them at a higher risk for serious side effects which were not adequately discussed.

Because of serious side effects caused by testosterone replacement therapy, a number of drug manufacturers are facing thousands of lawsuits filed by men or loved ones of those who were harmed or who died after using testosterone products.

Testosterone Replacement Products

Testosterone therapy can be administered as a gel, a patch or injection. Products that treat low or inadequate testosterone levels include:

• AndroGel topical gel (AbbVie)
• Androderm transdermal patch (Actavis/Allergan)
• Axiron topical solution (Eli Lilly)
• Testim topical gel (Endo/Auxillium/GSK)
• Testopel topical solution (Endo/Auxillium)
• Bio T Gel topical gel (Teva)
• Delaestryl injection (Endo)
• Depo-Testosterone injection (Pharmacia Upjohn/Pfizer)
• Fortesta topical gel (Endo)
• Striant buccal tablet (Endo)

Side Effects of Testosterone Therapy Treatment

Like most other medications, testosterone replacement has a number of side effects, most of which are mild to moderate but others may be severe or life-threatening. Testosterone may increase the risk of:

• Blood clots
• Deep vein thrombosis (DVT)
• Venous thromboembolism (VTE)
• Pulmonary embolism (PE)
• Myocardial infarction (MI) or heart attack
• Cerebrovascular accident (CVA) or stroke 

Symptoms of serious side effects
Heart attack	pain or pressure in chest, arm or shoulder difficulty breathing cold, clammy feeling sense of impending doom
Stroke	difficulty walking, speaking, or understanding paralysis or numbness of the face, arm, or leg drooping of face on one side
Pulmonary embolism	sudden pain in chest shortness of breath, coughing light headedness heart palpitations
Deep vein thrombosis	pain in leg, calf or foot swelling or redness in leg, calf or foot may have no symptoms

Any of these events may be life-threatening and should be treated as a medical emergency.

Testosterone increases the risk of conditions that may contribute to cardiac and vascular problems such as:

• Hypertension
• Difficulty breathing
• Sleep Apnea
• Edema
• Elevated hemoglobin and hematocrit
• Impaired cholesterol metabolism
• Blood clots

Studies have shown that men over the age of 65 may have double the normal heart attack risk with testosterone therapy and this was seen within short term use (under 90 days). Among younger men, those with a history of heart disease had a two to three-fold increase for the risk of heart attack within the first 90 days of treatment. In younger men without previous cardiac history, no increased risk was shown.

Men who have other conditions such as hypertension, diabetes or poor cholesterol profiles may also be at an increased risk of both heart attack and stroke.

Common Testosterone Side Effects

Testosterone has a number of side effects which occur because it is a male hormone. Common side effects that are not dangerous to most and may be considered beneficial in some cases may include:

• Acne
• Aggressive behavior
• Oily skin
• Increased body hair growth
• Increased sex drive
• Gynecomastia
• Hypertension
• Headache
• Weight gain
• Hot flushes

Prostate and Testicular effects

Testosterone replacement has been shown to increase the risk of prostate disorder including:

• Prostate enlargement
• Difficulty urinating
• Elevated PSA levels
• Prostate cancer

Some men also see testicular atrophy (shrinking testicles), particularly with long term use, oligospermia (slow sperm) and priapism (extremely prolonged erection which can cause penile damage).

Liver Damage

Testosterone is metabolized in the liver and use of testosterone and other hormones has been shown to increase liver enzyme levels. Those who use testosterone for a long period of time may be at an increased risk of liver cancer, hepatic encephalopathy or liver failure. It is suspected that some well-known athletes may have developed liver cancer after years of steroid (testosterone) use.

Dangers to Women and Children

As testosterone is responsible for the male secondary sex characteristics, it should not be taken or used except under rare circumstances. Women and children who come into skin contact with testosterone gel or other forms of testosterone may absorb some of the medication which could result in adverse events. Testosterone can cause the development of male characteristics such as body hair, deepened voice, reproductive anomalies in women and children and may cause the long bones (arms and legs) to stop growing prematurely in children.

FDA Investigations

In January of 2014, the U.S. Food and Drug Administration announced its investigation of AndroGel and other testosterone replacement treatments used for men. The investigation was prompted by the results of two studies. One of the studies showed a two-fold increase in heart attacks in those on testosterone who were over the age of 65. The second study showed a connection between testosterone and increased risk of both stroke and heart attack.

In July of 2014, separate from the heart attack investigation, the FDA required that manufacturers begin including warnings about an increased risk of clot disorders including deep vein thrombosis (DVT) and venous thromboembolism (VTE). Either of these conditions may result in life-threatening events including pulmonary embolism, heart attack and stroke.

Based on the January 2014 investigation, the FDA concluded in mid-2015 that a warning label would be required regarding the increased heart attack risk. All labelling for testosterone replacement products now requires both warning statements.

Testosterone Lawsuits

Thousands of Testosterone lawsuits have been filed against testosterone manufacturers for injuries and deaths related to use of testosterone replacement therapy. Many of the lawsuits may be settled through agreements being offered by the manufacturers.

Men who were injured or loved ones of those who died from heart attack, stroke, pulmonary embolism or other side effects may be eligible for compensation and should seek legal advice.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.