Cincinnati, Ohio Pharmaceutical injury lawyer reviewing Low T clinic heart attack and pulmonary embolism risks and Testosterone Replacement medication complications in male plaintiffs nationwide.


Since early 2000, the pharmaceutical industry engaged is aggressive marketing campaigns targeting older men with often “non-branded” disease awareness marketing for a condition known as “Low T.”  The campaigns implied that “Low T” was a medical condition and that hormone replacement would offer benefits.

The Low T marketing, however, has been criticized as being “off-label” and for omitting serious testosterone side effects discussed below. Litigation is ongoing to determine whether these allegations are true.

In response, on March, 3, 2015, The FDA announced that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.

The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”

Testosterone replacement and Low T clinic promise great results but there are several health risks involved, including heart attack, pulmonary embolism and stroke risks for Low-T patients. Dangerous testosterone medications are being investigated by the FDA, and experts urge caution for patients.

Following Low T clinic injury, plaintiffs have filed lawsuits alleging low-testosterone drugs cause serious heart problems, pulmonary embolism, blood clots and other injury.

Attorneys argue the drug manufacturers of testosterone replacement therapy drugs are liable for their failure to warn of certain complications like stroke and heart attack, as well as negligence in marketing, branding, and consumer fraud for concealing information about product safety findings.

According to the Mayo Clinic, taking testosterone supplements for low levels naturally caused by aging is not advisable, which is also the position of the U.S. Food and Drug Administration.

The FDA is investigating the safety of low-T therapy after two studies indicated a potential for an increase in the risk of heart problems. In 2014, the FDA issued a Safety Announcement and a requirement for general label warnings of the increased risk of pulmonary embolism and blood clots.

In 2015, the U.S. Food and Drug Administration (FDA) began recommending that testosterone be approved only for people who have low testosterone due to certain medical conditions.

The FDA warnings are meant to alert the public that taking testosterone is not without risks. The benefits and safety are still undecided by the medical science community. Thus, doctors and patients are left to risk heart attacks and blood clots linked to testosterone replacements.

Joe Lyon is an experienced Cincinnati, Ohio drug injury attorney and pharmaceutical lawyer representing injured plaintiffs nationwide in testosterone therapy Low T injury lawsuits.


Testosterone Safety Warnings


Many men suffer from low testosterone levels, and doctors have recommended testosterone replacement medications. But low-T drugs may lead to dangerous side effects like blood clots and heart attacks.

This FDA testosterone therapy warning is based on evidence that testosterone may increase the risk of heart attack and stroke. There may be conflicting studies out there, but there is no long-term research to point to proven benefits of Low T Therapy.

A 2014 study reported that testosterone therapy might increase the risk of a heart attack in older men, as well as in younger men with a history of heart disease. Another study found a higher frequency of death and cardiac issues in men who had coronary artery disease and received testosterone replacement therapy.

As a result, the Food and Drug Administration (FDA) released a special advisory stating testosterone product labels must alert consumers of a possible increased cardiovascular risk.


 

Venous thromboembolism (VTE)


Recent studies have concluded that testosterone therapy is associated with an increase in the short-term risk for venous thromboembolism (VTE) among men with and without hypogonadism. Researchers are concerned the association between testosterone therapy and blood clots could be more pronounced among younger men.

The study, published in the Journal of Clinical Medicine, BMJ and JAMA, assessed the time of thrombotic thrombotic events like VTE after beginning testosterone therapy (TT) in men who sustained VTE. Thrombotic events were greatest at around 3 months after starting testosterone replacement therapy, with a decline in adverse health events by 10 months.


Low T Clinic Injury


Low testosterone, or male hypogonadism, is a condition in which the testes do not produce enough testosterone, the male sex hormone. Testosterone helps maintain and develop sexual features, muscle mass, levels of red blood cells, bone density, sense of well-being, and sexual function.

But low testosterone levels are very common with around 40 percent of men aged 45 and older with low levels.


Symptoms of low testosterone may include:

  • Low sex drive
  • Erectile dysfunction
  • Depression
  • Difficulties concentrating
  • Memory loss
  • Fatigue
  • Loss of muscular strength
  • A decrease in hemoglobin
  • A decrease in body hair
  • Thinning of the bones (osteoporosis)
  • Increased body fat
  • Breast development (gynecomastia)

Testosterone Therapy Heart Attacks


Based on FDA findings, some testosterone products may increase the risk of cardiac events, blood clots, heart attacks and strokes. Low T Clinic health care professionals have a duty to warn patients of hormone therapy risks.

Normal levels of testosterone are critical for the optimal health in men—to maintain muscle mass, bone density, sperm production, red blood cell count, sex drive, and fertility. Recent research indicates that testosterone therapy is associated with an increased risk of cardiovascular disease in men.

A study conducted by the National Institutes of Health concluded that men 65 years of age and older had a two-fold increase in risk of heart attack within 90 days of starting testosterone therapy.

A study published in the Journal of the American Medical Association found that men with a history of heart disease had a 30 percent increase in heart attacks and stroke after starting testosterone therapy.

Testosterone manufacturers are now required to conduct clinical trials to confirm the increased risk of heart attack, pulmonary embolism or stroke. Patients using testosterone treatments should seek medical attention if symptoms of a heart attack or stroke are present, including:

  • Chest pain
  • Shortness of breath or trouble breathing
  • Weakness in one part or one side of the body
  • Slurred speech

Testosterone Pulmonary Embolism


Some studies have indicated that starting testosterone treatment is associated with an increased risk of pulmonary embolism and heart attack in patients, which peaks within six months and declines if therapy is discontinued.

Hormone replacement has its known risks, and when testosterone replacement therapy is undergone by patients, they must be aware of the injury risk, including an added risk of blood clots and cardiac events. The FDA issued a warning in 2015 that testosterone therapy can potentially cause blood clots in men.

Pulmonary embolism is a blockage in a pulmonary artery in the lungs, typically caused by blood clots that travel to the lungs from the legs or other parts of the body. The blood clots block blood flow to the lungs, making pulmonary embolism life-threatening.

Prompt treatment greatly reduces the risk of death. In most cases, multiple clots are involved. Parts of the lung served by each blocked artery are refused blood and will suffer pulmonary infarction, making it difficult or impossible for the lungs to provide oxygen to the rest of the body.

The U.S. Food and Drug Administration cautioned doctors and patients that some testosterone products are approved only for men who have low testosterone caused by specific medical conditions.

For years, consumer safety attorneys have been concerned that Low T clinics have been marketing testosterone replacement therapy to those who do not need it. Not only do some patients not benefit from a Low T therapy, the treatment may increase heart attack and pulmonary embolism risks.


Testosterone Replacement Treatments


The benefits and long-term safety of testosterone therapies have not been well-established, thus concerning patient safety lawyers across the country. With the reports of heart attacks and blood clots experienced following Low T treatments, testosterone therapy lawsuits have been on the rise.

The FDA has worked to provide some warnings. The agency required that testosterone replacement manufacturers change their labeling to clarify the specific approved uses. FDA requirements also include labeling about a possible increased risk of heart attacks, blood clots and strokes.

Doctors at Low T clinics have been urged to only prescribe testosterone therapy to men with low testosterone levels caused by certain medical conditions.

FDA-approved replacement therapies are for men with a condition called hypogonadism, which means low testosterone levels are due to disorders of the testicles, pituitary gland, or brain. The FDA is well-aware that testosterone is used regularly in to relieve low testosterone symptoms due to aging. The benefits and safety of this use is still unknown.


Testosterone Treatment Options


In males, the testicles make a hormone called testosterone. This hormone helps form male sexual characteristics and plays a role in maintaining muscle mass and normal bone density. Testosterone production starts to naturally decline around age 30.

Blood tests can measure testosterone levels and can indicate a low, high, or normal range. Testosterone therapy may be necessary if the levels drop significantly if for reasons other than aging. Testosterone therapies and Low T treatments are available as an injection, a patch, a gel, or a tablet placed in the mouth. Hormone replacement therapy may have many risks, including cardiovascular health risks.


What is Hypogonadism?


Hypogonadism is a well-recognized medical condition caused by Klinefelter’s syndrome, pituitary injury or toxic damage to the testicles. The FDA approved products for hormone replacement therapy in men with a condition known as “classic hypogonadism.”


What is Low T?


“Low T” or “Andropause” are age related conditions where a man’s testosterone level drops as he gets older. This is natural.  The pharmaceutical industry, however, recognizing that all men will have lower testosterone as they age, and praying on the ambiguity in the diagnostic criteria of lower testosterone levels, promoted the condition of “low t” or “andropause.”

With therapy, however, testosterone side effects can for outweigh the benefits. As mentioned above, this type of use is not FDA approved, and the safety and efficacy is not established for patients who do not have “classic hypogondism.”

Nonetheless, the “Low T” marketing campaigns promoted the use of testosterone therapy for the age related lower testosterone targeting general symptomology that may nor may not be associated with low testosterone levels.

The symptoms such as decreased energy or decreases in muscle mass may have nothing to do with lower testosterone levels but may be the result of other coexisting conditions, concomitant medications or simply the aging process. The majority of men on Low T therapy are not those with “classic hypogonadism” but men with “low t,” which is not an indicated and approved use of the drug.


Testosterone Therapy Drugs


Several testosterone supplement producers, such as AbbVie Inc. and Eli Lilly & Co., have made statements regarding how they do not condone the use of their drugs for purposes other than what is on their labels.  In general, the uses outlined on such labels are in reference to men with low testosterone due to certain diseases or recent chemotherapy.

However, many advocates of the reduction in testosterone supplement usage argue that the language on the labels is not clear enough and can lead doctors to believe the drugs are suitable for patients simply experiencing “Low-T” symptoms.

Notably, approximately one out of four men prescribed testosterone have not even had a test to determine their testosterone level before taking the drug, thus providing another reason to conclude that the drugs are often being prescribed in the wrong contexts.

There are a number of ongoing observational and retrospective cohort studies related to the safety of testosterone replacement therapy. However, the only way to truly understand the risk is to perform a controlled clinical trial such as the Women’s Health Initiative.

While the FDA has encouraged the manufactures to design such a study, there is no indication when or if such a powered study will take place.

Popular testosterone drugs include:

  • AbbVie Inc’s AndroGel
  • Auxilium Pharmaceuticals Inc’s Testim
  • Eli Lilly & Co’s Axiron

Other Low T Injury Risks


  • There may be an increased risk of sleep apnea following testosterone therapy that can also affect your cardiovascular health. Sleep apnea can raise the blood pressure, which in turn increases the risk of strokes.
  • Testosterone therapy may also increase cholesterol levels, and a cholesterol buildup in the arteries can lead to potential heart attack.
  • Testosterone replacement therapy may also affect the natural production of testosterone if hormone levels are normal, and not very low. Testosterone therapy may reverse natural trends, which can have both benefits and risks. Researchers continue to study the risks and benefits of testosterone therapy.
  • Testosterone therapy may stimulate noncancerous growth of the prostate, enlarge breasts, limit sperm production, and contribute to the formation of blood clots.

Testosterone Therapy Malpractice


Low T therapy has become big business. There are now dozens of televised ads, and sales of hormone therapies have reach billions of dollars. Testosterone replacements are available as an injection, a gel, an underarm spray, and a nasal spray.

The advertisements tout the huge benefits, and often downplay the health risks for male hormone replacement. The therapy may boost energy, mood, and sex drive. But what some companies and doctors don’t tell patients is that there are potentially fatal risks involved. Heart attacks and pulmonary embolisms are reported in many Low T malpractice cases.

While testosterone therapy may seem like a great idea for many men, the treatment may only be right for some. Speak frankly with your doctor about the risks and benefits. If you are taking testosterone treatments, make sure your doctor is monitoring your health with regular blood tests.

Every year, hundreds of new drugs and supplements are put to market with approval from the U.S. Food and Drug Administration (FDA). However, some companies fail to properly test these products before they are prescribed by doctors and consumed by patients.

Some dangerous drugs end up causing serious side effects and complications that drug companies may or may not have known about, leading to warnings and product recalls.

In either case, consumers are injured and pharmaceutical companies are liable for subsequent damages and injury. Testosterone therapy can be extremely helpful, or quite damaging, and several different patient reactions have been reported.


Joe Lyon is a highly-rated Cincinnati drug injury lawyer and Ohio product liability attorney investigating Low T injury lawsuits for plaintiffs nationwide.

If you or someone you know has suffered a heart attack, pulmonary embolism or other Low T injury following testosterone replacement therapy, please contact the Lyon Firm at 800.513.2403 to learn about your legal options.