Chicago, ILMuch has been written in recent months about the massive growth of testosterone supplementation therapy, and the apparent advantages of the so-called “Low-T” fix that are not so advantageous for the majority of men seeking its benefits. Testosterone is not, according to the editors of Harvard Health, a fountain of youth. If anything, testosterone side effects, for those who don’t really need testosterone medically, can be dangerous.
We already know of the potential risk for testosterone stroke and testosterone heart attack due to a high concentration of red blood cells (polycythemia), allowing for a thickening of the blood leading to blood clots. But now there is a new worry, according to a recent cautionary release by the US Food and Drug Administration (FDA). In recent weeks the federal drug regulator has actually expanded on the aforementioned blood clot warning, given reports that blood clotting can occur in men where polycythemia is not present.
In the most serious cases, it can lead to testosterone death.
This is tragic, because while testosterone therapy is useful for those who are truly in medical need due to chronically low levels of testosterone - known as hypogonadism - in spite of the risks, the majority of men running to the testosterone trough are doing so driven by clever marketing, rather than in response to an accurate diagnosis.
That’s why many a testosterone lawsuit naming a manufacturer of a testosterone supplement as a defendant, also speaks to the widespread marketing that is alleged to promise the moon while minimizing the risks.
Defenders of the Low-T marketing phenomenon point to the fact that online, self-diagnosing websites stress the need to seek the advice of a medical professional before proceeding. The problem, according to critics, is the role-reversal that occurs. Instead of the doctor performing a diagnosis and prescribing treatment, now the patient is coming in convinced of the need for testosterone supplementation to bolster sagging energy, and lobbies his doctor to prescribe it. It appears that doctors are listening to their patients.
It should also be pointed out that the most current studies can only reveal the potential for an association or link - rather than a cause and effect, according to Harvard Health (1/31/14). Still, the reality of the FDA weighing in with mandates for label updates with regard to the potential for blood clots and other testosterone side effects sends a message that testosterone supplementation therapy, in the absence of a sound medical diagnosis, is both misguided and risks needless side effects that can be serious.
There are other not-so-serious testosterone side effects as well, according to Harvard Health: the development of acne, enlarged or tender breast tissue, and the swelling of ankles. Far more serious, is the potential for testosterone stroke and testosterone heart attack in men who otherwise would not be at risk for those conditions.
Testosterone marketing campaigns are working - at least for the manufacturers. They are helping convince men that fatigue, erectile dysfunction and a low sex drive is not just a natural sign of aging. As for sites that allow for men to affect their own diagnoses, it’s important to note that testosterone levels can fluctuate naturally throughout the day. Harvard Health advocates that testosterone should be measured between the hours of 7 am and 10 am when testosterone is naturally at its peak. The result needs to be confirmed with a subsequent test, within the same time frame, but on a different day.
The marketing is working - but for whom?
It’s quite apparent that the wild growth of testosterone supplementation - which is continuing to expand - is the result of large numbers of men buying into the marketing hype. To minimize risks, the better response would be to take symptoms to a doctor, undergo the proper diagnostic testing without preconceived notions, and then be mindful of the risks and testosterone side effects associated with testosterone supplementation.
The FDA has always maintained that a treatment is appropriate when the benefits outweigh the risks for the intended patients. In this case, testosterone therapy has long been an accepted response for chronically low testosterone, such as that stemming from hypogonadism. There are health risks associated with extremely low testosterone, thus any risks associated with testosterone therapy may be mitigated when weighed against the potential benefits for the intended patient.
However, the risks may indeed outweigh the benefits for healthy men simply suffering from the normal effects of aging, with testosterone levels reflected in kind. Little wonder a testosterone lawsuit is launched when side effects - sometimes severe - are encountered for a therapy that is not medically necessary, and may have been born from evocative marketing expounding the benefits, without necessarily noting the potential risks.
Testosterone lawsuits are consolidated in Northern Illinois US District Court, Chicago, In re: Testosterone Replacement Therapy Products Liability Litigation, Case MDL 2545.
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