Washington, DCThere has never been any debate as to the effectiveness and usefulness of testosterone supplementation for a small cohort of men, for whom supplements can be vitally important. And testosterone therapy isn’t new, having been around for some time (with full blessing from the US Food and Drug Administration) as a treatment for hypogonadism, a condition characterized by severely low levels of testosterone that can lead to severe health problems. For those patients, any risk for testosterone side effects are deemed to be acceptable in view of the benefits for this particular segment of the patient population.
Testosterone supplementation, however, was never intended as a veritable fountain of youth for middle-aged men suffering from sagging energy and libido - normal byproducts of aging. And yet, latter-day testosterone issues that drive otherwise healthy men to the courts with a testosterone lawsuit in tow, appear to have grown from manufacturers identifying a new and potentially lucrative market: baby boomers unhappy with the normal, physiological aspects of growing older and looking for a way to cheat Father Time.
Enter testosterone supplements targeting otherwise healthy men seeking to bolster sagging energy and libido. While testosterone requires a prescription, manufacturers appear to have convinced consumers and various sectors of the health care industry that it’s acceptable to treat men without symptoms of hypogonadism, an indication endorsed by the FDA.
While testosterone supplementation can be useful in men with dangerously low levels of natural testosterone, treating otherwise healthy men with supplements due to naturally diminishing levels of testosterone from aging can be fraught with risk, according to testosterone side effects lawsuits. Those risks include the potential for testosterone stroke and testosterone heart attack in middle-aged men who otherwise may not have been at risk for such cardiovascular issues.
The FDA was caught up in the marketing wave and formally addressed the issue last year. “The FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the agency said. “The benefits and safety of this use have not been established.” In its safety communique to the health care industry, the FDA ordered manufacturers to add warnings for stroke and heart attack to product labels, and cautioned doctors against over-prescribing testosterone.
That’s easier said than done, it seems, given the robust marketing machine and a general lack of understanding as to the risks involved.
Those risks include, but are not limited to cancer of the prostate, sleep apnea, edema, gynecomastia (male breasts), elevated levels of bad cholesterol, a reduced sperm count, and red blood cells that tend to be larger. The latter, in lay terms, is a thickening of the blood that could lead to heart attack, stroke or even testosterone death in otherwise healthy men.
Those who have launched a testosterone lawsuit claim that manufacturers of testosterone supplements espoused the virtues and benefits of testosterone supplements - more energy, better muscle tone, increased libido, and so on - without fessing up to the potential risks.
Such lawsuits are characterized by the cases of five men who launched a testosterone side effects lawsuit in 2014 against AbbVie, the manufacturers of AndroGel, following grievous health complications allegedly associated with the use of testosterone supplements. Three of the five plaintiffs suffered a testosterone heart attack, while the other two suffered a testosterone stroke. All were between the ages of 50 and 63.
AbbVie, their lawsuit claims, “deceived potential users by relaying positive information through the press, including testimonials from retired professional athletes and statistics suggesting a widespread need for the drugs, while downplaying known adverse and serious health risks.”
There are more than 5,000 testosterone lawsuits in the pipeline, with bellwether trials due to be heard between the spring and fall of next year.
The noise generated by latter-day use of testosterone only serves to cloud the original, FDA-approved indication for testosterone supplements for men suffering from hypogonadism. For them, testosterone is an appropriate treatment where the benefit outweighs the risks. For anyone else, however, the opposite can be true. For health care professionals aware of the value of testosterone supplements for the intended patient constituency, the negativity over testosterone can be frustrating…
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