Cardiovascular Injuries from Testosterone Treatments
Recent medical studies found that testosterone treatments for men could cause an increased risk of clotting [DVT, Pulmonary Embolisms], stroke, heart attacks or even death in some men.
FDA Alert Regarding Testosterone
In January of 2014 the U.S. FDA published a “Safety Announcement” alert, stating they were evaluating the risk of stroke, heart attack & death with FDA-approved testosterone products. The FDA took note of the recent publication of two separate studies, each suggesting an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. Testosterone increases the risk of venous clots, strokes, heart attacks, and death in some men taking FDA approved testosterone products. The FDA has been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA provided a recent alert while it continue to evaluate the information from these studies and other available data.
What Does Testosterone Do?
Testosterone is a hormone that promotes the growth of the male reproductive system, contributes to proper sexual function, boosts libido, prevents loss of scalp hair and can reduce the accumulation of abdominal fat
Testosterone therapy or low T treatment is often prescribed to men who have low testosterone levels who do not have an associated medical condition. Testosterone helps improve sex drive, bone density and muscle mass. But the benefits and risks of the long-term use of testosterone therapy are not well known.
Testosterone Products Linked to Heart Attacks, Strokes, Death, and Clotting Disorders
Testosterone therapy is most often administered as a gel, transdermal patch, buccal system or injection. The following products treat low testosterone:
- AndroGel
- Androderm
- Axiron
- Bio-T-Gel
- Delatestryl
- Fortesta
- Striant
- Testim
- Testopel
- DepoTestosterone
Risk of Adverse Events from Testosterone are Increased in Men with Pre-Existing Heart Conditions
Risk for developing complication is higher if the patients have pre-existing heart conditions. Studies showed a 30 percent increased risk of heart attack, stroke or death among men with existent heart problems.
Men who did low T therapy with the following signs of health problems had the greatest increased risk of stroke, heart attack or death, according to the study. Heart problems that could potentially elevate the risk of men undergoing testosterone treatments included the following: plaque buildup, artery blockage, high cholesterol, diabetes, obesity.
Recent Medical Studies Linking Testosterone to Increased Risk of Stroke, Heart Attack & Death
1. Vigen R, O’Donnell CI, Baron AE, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013;310(17):1829-1836.
Vigen, et al performed an observational study of older men in the U.S. Veteran Affairs health system published in the Journal of the American Medical Association (JAMA) in November 2013.1 The men included in this study had low serum testosterone and were undergoing imaging of the blood vessels of the heart, called coronary angiography, to assess for coronary artery disease. Some of the men received testosterone treatment while others did not. On average, the men who entered the study were about 60 years old, and many had underlying cardiovascular disease. This study suggested a 30 percent increased risk of stroke, heart attack, and death in the group that had been prescribed testosterone therapy.
A second observational study reported an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease, who filled a prescription for testosterone therapy. The study reported a two-fold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first prescription. Among younger men less than 65 years old with a pre-existing history of heart disease, the study reported a two- to three-fold increased risk of heart attack in the first 90 days following a first prescription. Younger men without a history of heart disease who filled a prescription for testosterone, however, did not have an increased risk of heart attack.
3. https://www.endocrine.org/news-room/current-press-releases/endocrine-society-calls-for-large-scale-studies-to-evaluate-testosterone-therapy-risks (Accessed on February 25, 2014).
Based upon the new study data, the Endocrine Society issued statements alerting clinicians to the potential concerns about testosterone therapy and cardiovascular safety. While the FDA is investigating the available data, they have not, as of this date, concluded that testosterone therapy treatment increases the risk of stroke, MI, or mortality–they are just “studying” the issue.
Lawsuits are Being Filed for Testosterone Related Injuries
On June 6th, 2014 the United States Judicial Panel on Multidistrict Litigation (JPML) (the panel) established MDL No. 2545, In re: Testosterone Replacement Therapy Products Liability Litigation and selected the United States District Court for the Northern District of Illinois as the transferee court. The Panel assigned this matter to the U.S. District Judge Matthew F. Kennelly for coordinated or consolidated pretrial proceedings.
The Panel, after hearing arguments, issued the order consolidating all testosterone lawsuits on the grounds that all of the claims share “common questions of fact, and that centralization of all actions in the Northern District of Illinois will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.” The Panel quoted the January 31, 2014, U.S. Food and Drug Administration (FDA) announcement that it is currently investigating the risk of stroke, heart attack, and death in men taking testosterone drugs approved by the FDA.
Nurse Attorney Liz Dudley is Currently Investigating Testosterone Related Injuries in Men
If you are a male & had a diagnosis of prior heart or cardiovascular disease & had a heart attack while on any of the above testosterone products, please contact us for a free case evaluation. Hurry, as you only have a limited amount of time in every state to protect your rights if you have been injured by this product. It takes time for us to adequately investigate your case and to get it on file if we determine that you have a case. Contact nurse attorney Liz Dudley or fill out the contact form below for your free case evaluation.
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