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The Dangers of Testosterone Replacement Drugs

By Andrew Sullo

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During most any football game you are sure to hear at least one commercial touting the benefits of testosterone drugs for those men with “low-T” who are experiencing a declining interest in sexual activities, are more fatigued, or are experiencing muscle weakness, weight gain around the waist, depression or erectile dysfunction. While there is a very real medical diagnosis of low testosterone, this hormone declines naturally as men age. Testosterone production peaks around age 18, staying relatively stable until the age of 30-35. From that point on, a man’s testosterone levels decline about 1-3% every year. Many men, looking for the “fountain of youth,” whose testosterone levels are perfectly normal for their age, are taking testosterone and risking their health in the process. A much better approach could be to lose a little weight, engage in a regular exercise program, improve the diet—and realize that many of these symptoms are part of the natural aging process.

Americans looking for a quick fix have turned to testosterone boosters to repair their flagging energy, revive their sex drive and address erectile dysfunction. Younger men are even self-diagnosing, taking testosterone drugs without a valid medical diagnosis of low testosterone. Anti-aging clinics catering to men have sprung up across the nation, with regular promotions of testosterone drugs. The market for testosterone drugs increased by almost 500% between 2000 and 2011, and in 2011, the total number of prescriptions numbered over 5 million, bringing in over $1.6 billion dollars for the manufacturers of the drug. Testosterone drugs can be administered via creams, gel, pills, cream, patch, injection or implant. The pill form, in particular, has been linked to liver damage as the supplement is metabolized.

Are Men at Risk for Testosterone Heart Attacks?

A study recently published in the Journal of the American Medical Association, looked at more than 8,000 male veterans with low testosterone levels. When cardiovascular risk was compared between this group and a similar group with low testosterone who did not take a testosterone drug, the men taking the testosterone supplement were nearly 30% more likely to suffer a heart attack, stroke or even die after using the drug for three years. The long-term safety of testosterone drugs are now under scrutiny, with few studies addressing the issue.

As noted by Dr. Michael Ho—a cardiologist with the VA Eastern Colorado Health Care System, who helped direct the study of veterans—by definition, all the men in the study were over the age of 60 and had health problems associated with their age group including obesity, diabetes, high blood pressure and other ailments as well. An endocrinologist involved in the study, agreed with Dr. Ho to a point, however stated that caution should definitely be exercised when prescribing testosterone drugs to men over the age of sixty, as well as to younger men without a valid medical diagnosis of low testosterone.

The Likelihood of Testosterone Strokes Among Men Taking the Drug

The study published in JAMA also noted that a different random, clinical trial of testosterone therapy among men with known cardiovascular risks was stopped before completion due to the number of men who suffered adverse cardiovascular events during the study. All the participants in this study had a total testosterone level of less than 300 ng/dL. Most adult males from the ages of 18- 30 or so will have average testosterone levels of 800 ng/dL. This number will decrease approximately 1-3% each year thereafter. Of the 1,223 patients in the study, 26% suffered an adverse vent such as a stroke, heart attack or death within three years.

Deaths Related to Testosterone

In the JAMA study of the more than 8,000 men, after a median follow-up of twenty-seven months, 748 men died, 443 suffered a myocardial infarction, and 519 had a stroke. At one year the “absolute rate” of those who had an adverse cardiovascular even was 10.1% in those not taking testosterone and 11.3% in those who did take testosterone. These numbers don’t sound particularly frightening, however longer usage produced higher risks. At two years, the absolute rate of men experiencing a cardiovascular even was 15.4% in men not taking a testosterone supplement and 18.5% in those taking the drug. At three years, the numbers were 19.9% for men not taking testosterone and 25.7% among men taking a testosterone supplement. This particular study was not calibrated to detect differences between routes of administration, whether through the skin or taken orally.

Testosterone Related Deep Vein Thrombosis, Pulmonary Embolism, and Other Problems

After a recently released study in the Journal of American Medical Association, many doctors—as well as the FDA—are reconsidering the possible dangers associated with testosterone supplements. The number of men taking testosterone drugs has quadrupled in the United States since 2000, and just last year, the sales of testosterone supplements surpassed those of Viagra. The FDA approved testosterone supplements for the treatment of medically diagnosed issues such as hypogonadism, endocrine tumors and for those undergoing chemotherapy, however due to aggressive marketing campaigns on the part of testosterone manufacturers, testosterone is now being pushed to every man who has experienced a lowered libido, a decrease in bone density, strength or muscle mass, or those with lowered levels of energy. These “symptoms” of Low-T were once known as the normal effects of aging. The JAMA study concluded that men taking testosterone drugs were nearly 30% more likely to suffer a stroke, heart attack or even death.

As men age, the walls of their arteries become thinner. Testosterone, which causes an increase in blood clotting, could lead to a higher number of strokes, deep vein thrombosis or pulmonary emboli among older men taking the drug. Deep vein thrombosis (DVT) occurs when a blood clot forms in a deep vein of the leg, typically in the calf or thigh. While those who develop DVT may experience no symptoms until the clot breaks away and turns into a pulmonary embolism, others may notice pain, swelling, redness, tenderness or warmth in the affected area. DVT is a medical emergency which kills over 3% of those who develop the condition. Because testosterone increases the incidence of blood clots, DVT may well result in men taking the drug.

Pulmonary embolism occurs when a blood clot blocks a major artery in the lungs. Symptoms of pulmonary embolism include sharp chest pain, a rapid heartbeat and coughing up blood. Dr. Charles Glueck published a study linking testosterone therapy to an increased risk of pulmonary embolism in October, 2011, in Translational Research. In this study blood clots occurred in as little as one month on testosterone therapy. If left untreated, 30% cases of pulmonary embolism are fatal. Those taking testosterone drugs should exercise caution, particularly in light of the latest study linking testosterone to heart attack, stroke and death. Doctors should conduct a risk vs. benefit assessment of their male patients prior to prescribing testosterone therapy.

Testosterone Supplementation—an Unproven Science?

In short, testosterone therapy remains a scientifically unproven method for preventing the physical and psychological changes that accompany the aging process, and a large percentage of those using testosterone supplements are victims of the massive hype associated with the drug. If you feel you have been harmed from taking a testosterone supplement, it could be in your best interests to speak to a skilled Sullo & Sullo attorney who can take your individual circumstances into account and determine whether you might benefit from filing a lawsuit against the manufacturer of the drug you believed to be safe. Our Sullo & Sullo attorneys have the knowledge and the experience necessary to ensure you are not harmed further by the legal system and will fight aggressively for your rights.

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