Testosterone therapy lawsuits are appearing more frequently as thousands of men report injuries shortly after beginning treatment. New research has shown the increased risk of complications in men that have been undergoing testosterone therapy, or low T treatment. The treatment, intended as a supplemental therapy for men with hypogonadism, could cause increased risk of ischemic stroke, myocardial infarction (MI) or even death.
On January 31, 2014, the U.S. Food and Drug Administration released a safety announcement warning consumers of the potential risk of testosterone therapy and announced that they will be conducting further investigation. Concern arose from two published studies that indicate higher risks of adverse effects in patients within the first three months of treatment.
These studies, published on PLOS ONE and the Journal of the American Medical Association (JAMA), provide statistical information linking the usage of testosterone therapy to increased risk of myocardial infarction. Within the initial 90 days of treatment, results show a two to three fold increase chance of MI in men over 65 and those under 65 with a history of heart disease. Studies also show that many men undergoing treatment do not actually suffer from decreased levels of testosterone. Nearly 43 percent of men given the treatment show normal levels of testosterone and are using the medication to combat natural signs of aging including decreased libido, muscle loss and decreased bone density.
Previous studies have been conducted to test the safety of testosterone therapy and found similar results as the drug relates to heart conditions however this study focuses on the increased risk treatment poses for men under the age of 65. Though the research found that injuries were most commonly found in men with a previous history of heart disease, all men are cautioned when using testosterone therapy treatments.
Testosterone Therapy Complications
Testosterone therapy complications, though often minor and treatable, can lead to further complications such as the development of heart disease, heart attack, stroke or even death. Since the FDA released their safety announcement, five men have already come forward about injuries obtained while undergoing testosterone therapy. These men are believed to be the pioneers of testosterone therapy lawsuits as more victims emerge. These men have filed lawsuits against AbbVie, the makers of AndroGel, for suffering stroke, heart attacks and mini-stroke after using this product.
More than 5 million testosterone prescriptions have been written in the United States. Testosterone therapy is a popular method of treatment for men though many are unaware of the associated risks. Victims are holding the manufacturers of these medications accountable for their products.
In pending testosterone lawsuits, victims allege that the companies greatly undermine the risks associated with treatment. The companies also used misleading marketing tactics that implied the products could be used to treat conditions other than hypogonadism that lead to low testosterone. Since the FDA only approved testosterone therapy treatments for this condition, manufacturers of these products will be held responsible for causing injuries to users.
Medications used for treatment of low testosterone include:
AndroGel – Produced by AbbVie
Androderm – Produced by Actavis, Inc. (formerly Watson Pharmaceuticals)
Axiron – Produced by Eli Lilly and Company
Bio-T-Gel – Produced by Teva Pharmaceuticals
Depo-Testosterone – Produced by Pharmacia & Upjohn Company
Fortesta – Produced by Endo Pharmaceuticals, Inc.
Striant – Produced by Columbia Laboratories
Testim and Testopel – Produced by Auxilium PharmaceuticalsTestosterone Brands
Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. Published: January 29, 2014. https://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0085805
Trends in Androgen Prescribing in the United States, 2001 to 2011. Research Letter. JAMA Internal Medicine Aug 12/26, 2013 https://archinte.jamanetwork.com/data/Journals/INTEMED/927427/ild130115.pdf.gif
Testosterone Therapy Following Coronary Angiography Associated With Increased Risk Of Adverse Outcomes. JAMA Nov 5 2013. https://media.jamanetwork.com/news-item/testosterone-therapy-following-coronary-angiography-associated-increased-risk-adverse-outcomes/