We’re all familiar with the stereotype of a forty-year-old male combatting a receding hairline with Rogaine, frantically Googling for help on a low libido, and spending his life savings on a Porsche convertible. Even when they don’t conform to the drastic depictions in movies, midlife crises are common, and are often associated with low testosterone levels, colloquially called “low T.” The testosterone hormone is vital for a strong sex drive and muscle growth, so when levels naturally decline at ‘manopause,’ men experience weight gain, fatigue, and loss of libido, energy and muscle mass. Feeling that they’re being stripped of their manhood, and in search of virility, many men turn to prescription testosterone for an extra dose of masculinity.
The Drug’s Popularity
A surprising number of men take testosterone to fend off normal effects of aging rather than out of medical necessity. In 2014, over 2 million American men took testosterone drugs, up 300% since 2000. Many call the ‘wonder drug’ reinvigorating, improving mood and boosting energy levels. Some might be surprised to know that the FDA approves testosterone therapy only for specific medical conditions like hypogonadism (severe testosterone deficiency). Finally, after pressure to investigate vague labeling, in 2015 the agency mandated that Low T therapy manufacturers clarify these approved uses on their products’ labels. Without clearly spelling out the risks, drug manufacturers are leaving patients in the dark about possible risks and putting drug users’ safety on the line.
Hidden Side Effects
Typical side effects of testosterone therapy include rashes, itching and irritation. More serious effects include blood clot risk, and worsening of preexisting conditions like sleep apnea and prostate cancer. Studies have linked testosterone therapy to increased cardiovascular risk including heart attacks and pulmonary embolism. One study published in the Journal of the American Medical Association (JAMA) found that older men who used testosterone drugs had a 29% increase in stroke, heart attack and death.
Notable among testosterone therapies is AndroGel, a drug produced by AbbVie Inc, a division of Abbott Laboratories, Inc. Since it was first marketed in 2000, the FDA has issued multiple warnings about AndroGel’s serious side effects. AndroGel users have complained of symptoms of heart attacks and strokes, which include chest pain, shortness of breath, trouble breathing, weakness in one part of the body and slurred speech. The bottom line is that prescription testosterone can be dangerous.
Duty to Warn
Prescribers have a duty to warn patients about these risks so they can conduct a proper cost benefit analysis. In a recent statement the FDA said, “health care professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.” Overzealous providers like primary care doctors and urologists have perpetuated the t-therapy craze by ignoring the FDA’s warnings that laboratory tests must accompany prescription testosterone. The New York Times cites a 2010 FDA panel which found that at least 1 in 5 men taking prescription testosterone lacks routine testing to check for true hypogonadism. Such reckless overprescribing borders on abuse of doctors’ medical license.
Blaming Big Pharma
The issue of culpability extends beyond prescribers’ eagerness to use their Rx pad; the pharmaceutical giant AbbVie has spent millions of dollars promoting the drug to healthy aging males. In the last decade, the pharma industry launched a major media campaign to capitalize on a very captive audience of men seeking the fountain of youth. The low T phenomenon has ballooned into a $2B+ industry, with treatment available in the form of gels, patches, injections and pills under the names Testim, Androderm, Axiron, Bio-T-Gel, Delatestryl, Dep-Testosterone, Fortesta, Striant, and Testopel.
Pushback from the Research and Legal Communities
In the last few years, the pushback from clinical researchers has led to a call for legal action against testosterone therapy manufacturers. Users adversely affected by drugs like AndroGel should consult with an attorney on their eligibility for a class action lawsuit.
If you or someone you know suffers from heart disease or other negative side effects from taking testosterone therapy, call us or fill out our form for a free, no-obligation consultation.