Growing Evidence of Injury and Death Associated with ‘Low T’ Therapy
My father smoked. In fact, many in his generation—both men and women—smoked. They grew up during an era when the risks of smoking were just coming to light. Smoking cigarettes was often the “cool” thing to do as a teenager, glamorized for men by the rugged, testosterone-charged image of the Marlboro man; and for women, the likes of Virginia Slims featuring a cigarette as sleek as the actress smoking it who reminded women: “You’ve come a long way, Baby”. Never mind that the majority of men who played the Marlboro man died untimely deaths from smoking-related diseases, earning Marlboro Reds the inglorious nickname, “Cowboy Killers”.
And now we have the cure for “Low T”: those modern-day miracle medicines that promise a new and reinvigorated man with merely a swipe under each arm. Watching the ads for Androgel and Axiron—just two of several drugs currently on the market for treating “Low T”—one is led to believe that the results are near-synonymous with taking a bath in the Fountain of Youth. By “recharging” Low T levels, men can banish their blues, increase energy, up their libido, become more attractive, athletic and youthful, and certainly become better lovers (just ask the love-struck woman in the ads who hopefully has not come in contact with the stuff since it can be harmful to her and her children).
Testosterone is a hormone found in men and women, although average testosterone levels in males are 7-8 times greater than in females. Testosterone is the principal male sex hormone and plays a critical role in the growth and development of male reproductive tissues and related sexual characteristics, such as increased muscle mass and bone density, growth of body hair and deepened voice. It also is important for maintaining general health and influences feelings of well being.
The only way to find out if one’s testosterone levels are deficient is through a blood test. However, the question as to what constitutes “low” is fraught with controversy. Despite extensive discussion among clinicians, there is still no universally-accepted definition of “testosterone deficiency”. As such, criteria for prescribing testosterone medications lack sufficient clarity and standardization, leading to divergent and often permissive treatment practices. Coupled with aggressive and slick marketing tactics, the demand for testosterone has gone into overdrive in recent years, with a 500% increase in the number of prescriptions written. In 2011, the number of prescriptions written for testosterone topped $5 million representing $6.1 billion in U.S. sales alone.
Testosterone Impact on Cardiovascular System
Testosterone plays a key role in erythropoiesis, the production of red blood cells or hemoglobin, the component of blood that serves to deliver oxygen to the body’s tissues. Iron is an important element found in hemoglobin. A drop in red blood cells can cause anemia due to a decrease in the oxygenation of cells or because of low iron. Testosterone treatment increases the production of red blood cells which can clump together or coagulate, making the blood thicker. This can be particularly hazardous in men who have narrowed arteries due to aging or disease.
Testosterone Replacement Products
Testosterone replacement preparations are manufactured in different forms and can be taken as a pill, applied as a topical gel or cream, administered through a transdermal patch or intramuscular injection or implanted as a pellet under the skin.
Topical creams and gels which have enjoyed the greatest increase in sales over the past few years include:
You are a Man. You Want the Facts.
In a recent low T study published in the journal PLOS ONE, researchers reported that the rate of heart attacks in men 65 and older doubled in the months after starting prescription testosterone and doubled or tripled in younger men with a history of heart disease. The National Institute of Health (NIH)-funded study tracked 56,000 older and middle-aged men who had been prescribed testosterone between 2008 and 2010. This newest study echoes findings in previously published research.
By itself, the new study, “may not tell us very much,” said Dr. Michael Lauer, the director of cardiovascular sciences at the National Heart, Lung and Blood Institute, not involved in this particular study. “But when you put this together with the rest of the medical literature, this tells us that we potentially have a problem.”
In November 2013, a study published in the Journal of the American Medical Association found that treatments used to boost testosterone levels increased the risk of heart attack, stroke and other cardiovascular events in men with a history of heart disease. Researchers looked at the medical records of 8,700 male veterans who had undergone coronary angiography from 2005-2011, a procedure for testing arteries of people experiencing chest pain or with a high risk for cardiac problems. Their analysis revealed that men who had used testosterone were 30% more likely to have a heart attack, stroke or die during a three-year period than men with low hormone levels who had not taken the supplement.
In 2010, a federally-funded study published in the New England Journal of Medicine that investigated whether testosterone gel could help elderly men rebuild muscle mass had to be stopped prematurely because of heart attacks and other cardiac problems experienced by study participants.
The results of the newest study, combined with previous ones, have led the Food and Drug Administration (FDA) to initiate its own review of testosterone drugs.to assess whether new safety information—and/or a black box warning of the potentially fatal risks—should be included on labeling.
The FDA has approved testosterone therapy for men with low levels of testosterone caused by disease, genetic problems or side effects of chemotherapy. It has specifically not approved of testosterone products for use in men with low levels who lack an associated condition. But many critics assert that the FDA’s guidelines are ambiguous and leave way too much discretion to the health practitioner as to whom and when to prescribe.
A Lifetime Commitment
It is estimated that only 3-7% of men between the ages of 30-7% of men between the ages of 30-69 have a true testosterone deficiency called male hypogonadism. Symptoms include:
- Erectile dysfunction
- Decreased libido
- Decreased body hair and muscle mass
Doctors agree that men whose symptoms fit the classic description of hypogonadism can benefit from testosterone treatment. In addition to the potential for increased cardiac risk, possible side effects of testosterone use include:
- Dry skin and acne prostate problems
- Hot flashes
- Muscle aches
- Anxiety or depression
- Testicle shrinkage
- Further decrease in libido
- Limited sperm production
Manufacturers of testosterone treatments acknowledge that medications have also been known to cause other serious side effects, including:
- Swelling of the body
- Blood clots
- High blood pressure
- Breast pain or enlargement
- Difficulty or frequently urinating
- Prolonged or frequent erections
- Yellowing of the eyes and skin (jaundice)
- Increased potential risk for prostate cancer
“The stakes are high”, said Dr. Stephen “Kyle” Dreisbach, a family practice physician with Norton Healthcare who treats some men for Low T. “Once you start on it, you are going to suppress your own production of testosterone. It’s a lifetime commitment.”
Factors that place men at greatest risk for using testosterone treatment include:
- Advanced age (65+)
- Sleep apnea
- Prostate problems including an enlarged prostate or cancer
- Breast cancer
- Elevated levels of red blood cells
- History of cardiac problems, such as plaque buildup, artery blockage, high cholesterol and hypertension
- Other chronic health conditions impacting the cardiovascular system, including diabetes, kidney and liver disease
Testosterone decline is a normal part of the aging process and what is deemed a “normal” level for a 20-year old is not going to apply to a 65- or 70-year old male. Yet doctors are being inundated by requests from men of all ages who are looking for a boost in their energy and sex drive. Adrian Fugh-Berman, director of PharmedOut, a Georgetown University Medical Center project dedicated to evidence-based prescribing said that testosterone treatment “offers no proven benefits for health men. ‘Low T’ is invented by pharmaceutical companies to sell treatment products.”
Risks to Women and Children
Testosterone gel are at risk for incurring harm if they come into contact with testosterone gel, including touching the skin where gel has been applied or handling unwashed clothing or bed linens exposed to the gel. If a pregnant woman touches skin that has been covered with testosterone gel, her unborn baby may be harmed. Men who use testosterone gel should allow the area to thoroughly dry before putting on clothing that covers the area or allowing someone to touch his hands or skin where the medication has been applied. After applying the gel, men should wash their hands with soap and hot water to ensure that any residue of gel has been removed. If accidental contact is made, women and children should wash their skin with hot water and soap as quickly as possible.
Signs of a Woman Being Exposed to Testosterone Gel May Include:
- Hair Growth
- Enlarged genitals
A child who comes into contact with testosterone gel may show the following sumptoms:
- Enlarged genitals
- Signs of early pubescence or growth of hair on body
- Increased erections
- Increased sexual desire
- Aggressive behavior
If a woman or child has any signs of these symptoms, they should consult with their doctor immediately. Exposure symptoms may diminish over time, but increased size of genitalia may remain.
Furthermore, testosterone gel may cause bones to mature more quickly, meaning that children may stop growing before their anticipated adult height and be shorter than normal. Even if a child is no longer exposed to testosterone, the impact of limited exposure may have already caused permanent bone changes.
Risks Outweigh Benefits
Despite continued controversy over the treatment, there is growing consensus in the wake of recent studies that the publicized risks of using testosterone warrant lengthy consideration and discussion between the doctor and the patient. Fugh-Berman asserts that except for people with true hypogonadism, testosterone therapy is not a proven treatment and the risks of using it outweigh the benefits. The American Urological Society has recently joined in the need for caution saying that the therapy should not be prescribed for men who have normal testosterone levels and has included it on a list of five topics that the physician should question carefully prior to prescribing.
Testosterone Lawyer for Low T Lawsuit
If you are currently undergoing treatments for low testosterone or testosterone therapy, I urge you to consult with your doctor as soon as possible about emerging research demonstrating the risks associated with use. Furthermore, if you or a loved one has been harmed by exposure to testosterone products, please contact a pharmaceutical Low T lawyer immediately.
We are in the process of investigating legal claims for men who have experienced cardiovascular problems, including heart and stroke,as well as injury to women and children who inadvertently came into contact with creams or gel. Call our legal team at 314-409-7060 or 855-55-BAD-DRUG (toll free). We’re standing by to help you get the compensation you need and deserve.