According to scientific research, millions of men who are using medications to treat the natural decline in testosterone production that occurs with age––a condition commonly known as “Low T”––are at an increased risk of stroke, heart attack, blot clots, and even death. Two recent studies published in the medical journal PLOS One (January 29, 2014) and The Journal of the American Medical Association (November 6, 2013) reported the following:
- Those who took testosterone increased their risk of heart attack, stroke and death by nearly 30 percent.
- Side effects of AndroGel and other testosterone medications double the risk of heart attacks among men over the age of 65 within the first 90 days of starting treatment.
- For younger men under the age 65 with a history of cardiovascular disease, the risk of heart attack may be nearly tripled.
- These studies also show that nearly 43 percent of men undergoing treatment for “Low T” have normal testosterone levels, not decreased levels of testosterone and are simply taking the medication to combat natural signs and symptoms of aging.
As thousands of men continue to report injuries shortly after beginning testosterone replacement treatment, it is critical to learn the serious risks associated with such medications, as well as to understand your legal rights in the event you have been harmed.
FDA Issues Safety Warning and Evaluates Potential Testosterone Risks
Prompted to act by the growing body of concerning medical studies, the Food and Drug Administration (FDA) released a safety announcement on January 31, 2014, warning consumers of the potential risks of testosterone replacement therapy. The FDA also announced that they will be reassessing the safety of testosterone products by conducting further investigation into the link between testosterone treatments and an increased risk of stroke, heart attack and blood clots.
Additionally, with the publication of these studies and the warning issued by the FDA, the potentially devastating side effects of testosterone therapy have been widely reported by the media including the CBS Evening News with Scott Pelley and Fox News Sunday Housecall. These videos are extremely informative regarding the alarming risks associated with testosterone replacement treatments.
What is Testosterone?
According to the Mayo Clinic, testosterone is a hormone produced primarily in the testicles, which helps men to maintain:
- Bone density
- Fat distribution
- Muscle strength and mass
- Red blood cell production
- Sex drive
- Sperm production
What is Testosterone Replacement Therapy?
As men age, there is a natural decline in testosterone levels. As a result, some men experience the following signs and symptoms:
- Changes in sexual function and desire
- Changes in sleep patterns such as insomnia
- Physical changes such as increased body fat, reduced muscle bulk and strength, reduced energy levels, hot flashes, and decreased bone density
- Emotional changes such as decreased self-confidence or motivation, feelings of sadness or depression, and difficulty with concentration and memory
In order to combat this decrease in testosterone levels and associated symptoms, testosterone replacement therapy is being prescribed for men at an exponentially growing rate. Over the last decade in the United States, testosterone therapy prescriptions for men over 40 have quadrupled to more than 5.3 million translating to approximately $2 billion in annual sales. The New York Times reported that as of 2011, one in 25 men over the age of 60 was undergoing prescription testosterone treatment.
The FDA has specifically approved testosterone replacement therapy for the treatment of dramatically or abnormally low testosterone levels, a condition called hypogonadism, in which the body is unable to produce normal amounts of testosterone. However, before older men are prescribed medication for “Low T,” it is critical to determine if a low testosterone level is the result of hypogonadism or other disease, or the normal aging process for which testosterone replacement therapy is not approved.
Beyond AndroGel––Testosterone Replacement Therapy Products
Testosterone therapy treatments are projected to grow into a five billion dollar industry within the next several years. These popular treatments can be delivered as a gel, cream, patch, pill, injection or implant pellet. In addition to AndroGel, serious risks are associated with the following brand name “Low-T” medications:
- AndroGel — Produced by AbbVie — topical skin gel
- Androderm — Produced by Actavis — skin patch
- Axirom — Produced by Lilly USA, LLC — underarm topical cream
- Bio-T-Gel — Produced by Teva Pharmaceuticals — topical skin gel
- Delatestryl — Produced by Endo Pharmaceuticals — injection or solution
- Depo-Testosterone — Produced by Unigen Life Sciences — injection solution
- Fortesta — Produced by Pharmaceuticals — topical skin gel
- Striant — Produced by Auxilium Pharmaceuticals — buccal tablet dissolved between cheek and gums
- Testim — Produced by Auxilium Pharmaceuticals — topical skin gel
- Testopel — Produced by Auxilium Pharmaceuticals — subcutaneous pellet
Testosterone Treatment Lawsuits
Although a popular method of treatment, many men remain unaware of the potentially life threatening risks associated with testosterone therapy. In pending testosterone therapy lawsuits, victims are holding drug manufacturers accountable for their injuries, accusing them of compromising the health and safety of consumers in the following ways:
- Inadequate research and risk assessment: “Low T” treatment manufacturers failed to adequately research the risks of stroke, heart attack and blood clots related to testosterone therapy, especially among men with existing cardiovascular and related diseases such as high cholesterol, narrowed or blocked arteries, diabetes, obesity, and other previous heart problems.
- Reckless and misleading marketing practices targeting otherwise healthy men: The FDA only approved testosterone therapy for specific conditions including those related to hypogonadism, chemotherapy side effects and genetics. However, manufacturers of testosterone therapies recklessly marketed “Low T” medications to otherwise healthy men as a “cure-all” for a variety of general symptoms such as reduced energy, weight gain, decreased libido, and other issues related to the natural aging process.
Get Effective Case Evaluation From a Qualified AndroGel Attorney
If you are a male or have a loved one who has been prescribed testosterone replacement therapy and suffered a stroke, heart attack, blood clots or death, please contact the AndroGel attorneys at Slack & Davis today for a free and confidential consultation. Our team of highly skilled pharmaceutical attorneys will evaluate your particular case and take timely and effective action to recover full compensation for your injuries including medical expenses, therapy costs, lost wages, emotional distress, and wrongful death.