Update: First AndroGel Bellwether Ends in Mistrial
June 19, 2017 – The first attempt to hold AbbVie Inc. responsible for the side effects alleged from AndroGel has ended in a mistrial after the lead plaintiff’s attorney suffered from heart problems. Court documents indicate that the man was hospitalized with heart complications on June 10 and underwent an unspecified procedure, but has since been released and is now recovering back home.
What is Testosterone Replacement Therapy?
Testosterone replacement therapy is the use of patches, injections, gels, or other products to supplement levels of testosterone, a male androgen (hormone) involved in many aspects of physical, sexual, and emotional health.
What is the problem?
After age 30, testosterone levels naturally decline by 1-2% per year. This can lead to symptoms like fatigue, erectile dysfunction, depressed mood, loss of muscle tone, and more. While these symptoms are unpleasant, they are not a serious medical condition. In fact, the body may have good reasons for decreasing testosterone levels in older men — high levels of testosterone have been associated with cardiovascular events.
Testosterone Linked to 30% Increased Risk of Heart Attack, Stroke, and Death
Testosterone can increase the number of blood platelet cells, causing blood to clot more easily. It may also elevate blood pressure, increase free-circulating estrogens, and reduce levels of HDL (“good”) cholesterol. All of these factors can increase cardiovascular risks. In November 2013, JAMA published a study confirming these risks — researchers found that testosterone therapy was associated with a 30% increased risk of heart attack, stroke, and death among older men.
Doubled Risk of Heart Attack for Men Over 65
One of the largest studies of testosterone involved over 55,000 men. The study, published in January 2014 in PLOS One, concluded that men over 65 on testosterone were twice as likely to have a heart attack within the first 90 days of treatment. Men under 65 with pre-existing heart disease were three times as likely to have a heart attack. Days after this study was published, the FDA published a Safety Communication and launched an investigation.
Testosterone Therapy and “Low T”
In recent years, AbbVie and other pharmaceutical companies have launched an aggressive “disease awareness campaign” aimed at middle-aged men. The ads suggest that you might have “Low T” if you are feeling “sad and/or grumpy,” have deteriorating performance at work or in sports, decreased enjoyment of life, or are “falling asleep at dinner.”
These symptoms are so common and vague, it is no surprise that there has been a five-fold increase in the number of prescriptions for testosterone between 2000-2011. Of the 5.3 million prescriptions written in 2011, two-thirds were for a topical testosterone gel product called AndroGel, manufactured by AbbVie.
The problem is that only 50% of men on testosterone actually have hypogonadism, a serious medical condition in which the testicles produce little or no hormones, and 25% of men received a prescription without ever having a blood test.
Testosterone Replacement Therapy Products
- Androgel (AbbVie, Inc.) — Testosterone gel applied to skin
- Androderm (Actavis) — Testosterone patch
- Axiron (Lilly USA, LLC) — Underarm liquid
- Bio-T-Gel (Teva Pharmaceuticals) — Testosterone gel applied to skin
- Delatestryl (Endo Pharmaceuticals) — Injection
- Depo-Testosterone (Unigen Life Sciences) — Infection
- Fortesta (Endo Pharmaceuticals) — Testosterone gel applied to skin
- Striant (Auxilium Pharmaceuticals) — Buccal tablet (absorbed through mouth and gums)
- Testim (Auxilium Pharmaceuticals) — Testosterone gel applied to skin
- Testopel (Auxilium Pharamceuticals) — Pellet implanted under skin
FDA Updates Testosterone Labeling with ‘Addiction and Dependence” Warning
January 18, 2017 – FDA has approved class-wide label changes for all prescription testosterone supplements to include information about a risk of abuse and dependence linked to the products. The new warnings are intended to alert prescribers that some patients may abuse TRT boosters, and that adverse outcomes may result.
Do I have a Testosterone Class Action Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in testosterone lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Testosterone Treatment Class Action Lawsuit Evaluation: Again, if you or a loved one was injured by side effects of testosterone replacement therapy, you should contact our law firm immediately. You may be entitled to compensation by joining a testosterone class action or by filing a testosterone lawsuit, and we can help.