Following a pair of recent studies which determined that some testosterone users may face an increased risk of cardiovascular health problems, the European Medicines Agency (EMA) has announced that it will launch its own investigation into the matter. In recent years, the use of testosterone supplements has skyrocketed in the U.S. and abroad, driven in large part by aggressive marketing campaigns that encourage men to seek treatment for “Low T” if they experience any number of generic symptoms such as lack of energy, weight gain or muscle loss. Unfortunately, the widespread use of testosterone boosters has coincided with a massive increase in heart attacks, strokes, blood clots and other cardiovascular problems in users of these products.
Free Testosterone Lawsuit Evaluation: If you or a loved one has been injured by a testosterone supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the testosterone booster and we can help.
What’s the Problem?
On April 11, 2014, the EMA issued a press release announcing that it will be reviewing the safety of all testosterone replacement therapy (TRT) drugs. These products are already currently being investigated by the U.S. Food & Drug Administration (FDA). Medications containing synthetic testosterone include:
“The safety concerns were raised following the recent publication of a study suggesting that the use of testosterone increases the risk of myocardial infarction (heart attack) in men aged over 65 years, as well as in younger men with pre-existing heart disease,” the EMA said.
Studies Raise Questions About ‘Low T’ Health Risks
Problems with testosterone boosters first gained widespread attention following a November 2013 study published in the Journal of the American Medical Association which determined that the supplements may increase the risk of heart attack, stroke and sudden death in older men with a history of heart disease.
Two months later, in January 2014, a report in PLOS ONE found that testosterone therapy drugs may double the risk of heart attack in young men with heart problems, as well as in men over the age of 65 who had no such problems. The study’s authors estimated that for every 1,000 men over the age of 65 who undergo treatment with a testosterone booster, 11.52 may have a heart attack. That compares to only 5.27 men per 1,000 who do not take a testosterone supplement.
FDA to Reevaluate Safety of Testosterone Boosters
Earlier this year, the Food & Drug Administration launched its own investigation into the health risks posed by testosterone supplements following its review of the JAMA and PLOS ONE studies. Amid concerns regarding the overuse of these products, U.S. health officials stated that testosterone replacement therapy has only been approved for use in men who have clinically diagnosed low testosterone levels as well as an associated medical condition, such as hypogonadism.
The EMA review was requested by Estonia, and is being performed by the Pharmacovigilance Risk Assessment Committee (PRAC), which assesses drug safety concerns. After its review is complete, PRAC will give recommendations on what, if anything, the EMA should do regarding the issue of testosterone supplementation.
Do I Have a Testosterone 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 testosterone injury and death cases in all 50 states.
Free Testosterone Lawsuit Evaluation: If you or a loved one has been injured by a testosterone supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a Testosterone Suit and we can help.