Public Citizen Urges FDA to Add Black Box Warning to Testosterone Products due to Increased Risk of Heart Attack and Cardiovascular Dangers
An article published in the Journal of American Medical Association (JAMA) on March 26, 2014 provides that Public Citizen, a consumer advocacy group, has petitioned the FDA to add a black box warning to the labels of testosterone products to warn about heart attack and other cardiovascular risks. The black box warning is the strongest type of warning that the FDA can require, which alerts users that the product has a high risk of causing serious and life-threatening health effects. In a press release issued by Public Citizen, Sydney Wolfe, founder and senior advisor of Public Citizen’s Health Research Group, said that “[i]t is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks.”
On January 31, 2014, the United States Food and Drug Administration (FDA) issued a Safety Announcement that it is investigating a potential link between testosterone use and stroke, myocardial infarction (MI), and death, as demonstrated by published studies.
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.
“We continue to hear from individuals who allege to have experienced life-threatening and serious injuries after using testosterone products,” says Roger Denton of 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.
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.
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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