A large Veterans Affairs (VA) study of older men diagnosed with low hormone levels and other health issues revealed that testosterone treatments might be associated with increased risks for stroke, heart attack, and death, according to a The Associated Press (AP) report. The study revealed that men using testosterone products were 30 percent likelier to suffer from these serious reactions when compared to men who were not taking a testosterone supplement. Although a direct link has not been made, the study mirrored similar findings concerning the potential association between serious health reactions and testosterone supplementation, seen in a prior study.
The recent study, conducted at VA’s Eastern Colorado Health system, involved 8,700 veterans and found that testosterone risks were similar in men regardless of existing cardiac issues, according to the AP. About 26 percent of the men using a testosterone supplement experienced a so-called “bad” outcome—heart attack, stroke, or death—within three years of the study’s initial heart test. In non-testosterone users, just 20 percent experienced a negative outcome. Study results appear in the Journal of the American Medical Association.
It remains unclear if the negative outcomes apply to other men. What is known is that there is no established data to confirm that testosterone supplementation is safe in any group, including men using the treatment for its alleged anti-aging benefits, according to the AP report. In an editorial accompanying the study, one expert calls for more research. Also, former Endocrine Society president and current professor of medicine at the University of Virginia Health System, Dr. Robert Carey, pointed out that these treatments should never be prescribed for men with prostate cancers as they may cause the cancer to spread, according to the AP.
Testosterone Products May Lead to Other Serious Side Effects
Including heart attack, stroke, and death, the side effects that may occur with testosterone treatments for Low T—some of which appear on the package insert information—include:
- Enlarged prostate
- Possible increased prostate cancer risks
- High blood pressure
- Blood clots in the legs; leg pain, swelling, or redness
- Body swelling, with or without heart failure
- Lowered sperm count (with larger doses)
- Enlarged or painful breasts
- Sleep apnea
- Acne, skin irritation
- Increased cholesterol levels
- Increased red blood cell count
- Increased liver function tests
- More erections, longer lasting erections, than are considered normal
Testosterone Exposure May Lead to Adverse Reactions in Children, Women
According to the Medication Guide for Teva’s testosterone gel product, testosterone gels may present very serious risks to non-patients exposed to the medication. The product can transfer from the patient’s body to the bodies of others. Women, children, and pets should never be in contact with any unwashed or unclothed area in which the testosterone gel was applied on the patient’s body.
In children who are exposed to testosterone through contact with testosterone gel, early signs of puberty may be exhibited, including:
- Enlarged penis or clitoris
- Premature development of pubic hair
- Increased erections in boys
- Increased sex drive
- Aggressive behavior
In women, contact with the testosterone product might lead to:
- Changes in body hair
- Significant increase in acne
Low T Ads Misleading
Although testosterone products were designed for use in the treatment of very specific disorders, including hormone deficiencies caused by conditions such as endocrine tumors, or in response to chemotherapy, the medications are, more and more, being prescribed for what is being described as a “lifestyle treatment,” according to a recent The New York Times report. According to the report, many doctors feel that the condition—low testosterone or Low T, as the alleged condition is popularly known—is, in fact, a largely invented condition.
Advertising is being blamed, in large part, for the ongoing spike in testosterone prescriptions and talks about men’s drop in energy and sex drive, urging older men to speak to their physicians about Low T. Meanwhile, despite that many physicians consider Low T to be a fabricated condition, in 2012, drug makers in the United States, according to a Fierce Pharma report, spent a massive $3.47 billion on direct-to-consumer advertising. Last year, sales of prescription testosterone gels exceeded $2 billion in the U.S., and that figure is expected to increase by more than two-fold by 2017, according to The New York Times.
Testosterone, like estrogen in women, declines normally in men as they age and, the U.S. Food and Drug Administration (FDA) has approved the treatments for “for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts.” But, as The New York Times notes, there is ambiguity in the directive.
Advertising is focused on low sex drive, fatigue, and alleged anti-aging benefits, The Associated Press (AP) reported. Meanwhile, no large, long-term research has addressed testosterone replacement and many experts in the medical community are reticent to use the products for normal aging processes, noting that low testosterone is typically not a key factor in disorders such as erectile dysfunction (ED). In fact, a 2013 CMI/Compass survey revealed that more than half of the physicians surveyed said that pharmaceutical advertising should be reduced and 63 percent said that prevailing marketing is misinforming patients, according to The New York Times report.
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