Testosterone Drugs Under Review by Food and Drug Administration (FDA) and European Medicines Agency (EMA)
The FDA previously announced on January 31, 2014 that it would investigate a potential link between testosterone use and stroke, myocardial infarction (MI), and death in light of the findings of certain studies. Now Bloomberg reports that the European Medicines Agency, the regulatory authority in the European Union, has also announced that it will review testosterone medications after studies suggest an increase in cardiovascular risks.
The first study that prompted the investigations was published in the Journal of the American Medical Association (JAMA) in November 2013 and suggested that testosterone replacement drugs may increase the risk of heart attack, stroke and death. The study followed more than 8,000 male veterans with low testosterone. After comparing cardiovascular events in males taking a testosterone supplement with those who were not taking such supplements, the study concluded that men who used a supplement were 29% more likely to die, have a heart attack, or experience a stroke within three years of use. This was the result even after considering various factors that contribute to cardiovascular illnesses, such as age, blood pressure, and existing heart disease.
The second study that prompted the investigations was published in the online journal PLos ONE on January 29, 2014, and concluded that older men, and younger men with pre-existing diagnosed heart disease, have an increased risk of heart attack following initiation of testosterone therapy. In particular, the study reported that men ages 65 years or older have a two-fold increase in the risk of heart attack in the first 90 days following the first prescription of testosterone therapy. And among younger men less than 65 years of age who have 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 the first prescription of testosterone therapy.
The attorneys at Schlichter, Bogard & Denton, LLP are offering a free and confidential case reviews to those who allege to have been injured after using testosterone products. Schlichter, Bogard & Denton, LLP is a unique law firm that aggressively represents its clients injured as a result of dangerous pharmaceutical medications and unsafe medical devices, including testosterone products.
If you or a loved one has suffered injuries after using testosterone products, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.
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