Safety Announcement Issued by FDA to Investigate Risk of Stroke, Heart Attack and Death for Men Using Testosterone Products
On January 31, 2014, the FDA issued a Safety Announcement that it will investigate the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA reported that they have “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.”
“We continue to hear from individuals who have allegedly experienced life-threatening injuries after using testosterone supplements,” says Kristine Kraft, partner at Schlichter, Bogard & Denton, LLP. 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.
The first study that prompted FDA’s Safety Announcement 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 FDA’s Safety Announcement 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.
On February 3, 2014, The New York Times reported that the number of testosterone prescriptions given to American men has tripled since 2001. Further, the article noted that treatments for low testosterone are now an estimated $2 billion-a-year industry in the United States – with up to 25% of the prescriptions being written in the absence of a blood test to check the man’s hormone levels. Dr. Steven Nissen, chairman of Cardiovascular Medicine at the Cleveland Clinic, was quoted in a February 4, 2014 report from Yahoo! Health saying, “I’m very concerned that widespread use of testosterone supplements without any long-term safety studies is putting millions of men at risk for the most common lethal condition in the United States: heart disease. Dr. Nissen added, “The FDA needs to require makers of these drugs to do long-term studies of these drugs, which are being marketed to men as a fountain of youth, just as hormone replacement therapy (HRT) was to women 20 years ago.”
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. The attorneys at Schlichter, Bogard & Denton, LLP who represent victims harmed by pharmaceutical manufacturers include Roger Denton, Kristine Kraft, Beth Wilkins Flieger, Ashley Brittain Landers, and Tara Rocque. 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.
Schlichter, Bogard & Denton, LLP also welcomes the opportunity to work with other attorneys on these types of cases. Schlichter, Bogard & Denton, LLP is available to either handle these cases or work as co-counsel, so other attorneys with these types of cases are invited to contact an attorney at the firm to explore this opportunity.
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