News & Commentary

Testosterone Therapies May Be Linked to Increased Cardiac Injuries

“A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel… for treating something called low T, a pharmaceutical-recognized condition affecting millions of men with low testosterone, previously known as getting older.”

Stephen Colbert (October 3, 2012)

 

FDA Investigation

 On January 31, 2014, the FDA announced an investigation to evaluate the risks of cardiovascular complications associated with FDA-approved testosterone products. According to the FDA, the investigation was issued in response to several studies that show an increased risk of stroke, heart attack and death in men using the therapy.

Pharmaceutical Companies and Testosterone Therapy

In recent years, men have increasingly turned to testosterone therapy in hopes of improving lowered sex drives and energy levels, among other symptoms that are often associated with low testosterone levels. Although some individuals may regard testosterone therapy as the key to male vitality, several studies have linked the therapy to serious side effects and cardiac risks, especially among men who may not have a medical need for the therapy.

According to a 2013 report in the Journal of the American Medical Association, the use of hormones among men over 40 increased by almost 360 percent between 2001 and 2011. Pharmaceutical companies may have played a large role in this increase as they try to grow a market and overpromote their product by turning a life experience, such as aging, into a condition that requires medical diagnoses. Additionally, some pharmaceutical companies may not have specifically addressed heart attack or stroke warnings on the testosterone therapy labels.

Studies Link Testosterone Therapy to Increased Cardiac Injuries

Between 2005 and 2011, researchers with Veterans Affairs conducted a study of approximately 8,700 male Veterans with an average age of 60 who had a history of heart problems, and 1,223 of those participants were given testosterone therapy in various forms, such as injections, gels, or patches. According to the study, which was published in the Journal of the American Medial Association in November 2013, patients undergoing testosterone treatments were 30 percent more likely to suffer from heart attack, stroke, and death when compared to senior males not using the treatments.

Another study published in PLOS One revealed an increased risk of adverse outcomes associated with testosterone therapy in males over the age of 65, in addition to males younger than 65 who have pre-existing heart conditions. Researchers studied the records of more than 55,500 men who were prescribed various forms of testosterone therapy. According to Forbes, researchers found that the risk of heart attacks “doubled during the first three months after starting therapy in men younger than 65 who had a history of heart disease” and “also doubled for all men older than 65—those with or without heart disease.”

Testosterone Therapy and the Need for Medical Tests

Testosterone therapy may provide benefits for male hypogonadism, which is the failure of the body to produce enough testosterone, sperm, or both, and can result in fatigue, decreased sex drive, and difficult concentrating, among other emotional and physical changes. Men’s testosterone levels naturally begin to decline around the age of 30 and may also lead to these effects.

Since the symptoms of hypogonadism are similar to those of the aging process, it is imperative that men are properly tested before proceeding with testosterone therapy to avoid unnecessary risks. The FDA maintains that “[t]estosterone products are FDA- approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.”
 

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Newsome Melton is a law firm that represents consumers and families across the country who have been catastrophically injured by defective products. Rich Newsome, the firm’s senior partner, is the immediate Past-President of the Florida Justice Association, is Past-President of the Central Florida Trial Lawyers Association, and is currently on the Executive Committee of the National Trial Lawyers Association. You can send our Firm an email, follow us on Twitter, or like us on Facebook.