The prominent watchdog group Public Citizen has filed a petition with the FDA requesting the strongest warning possible – a so-called ‘black box warning’ – to be placed on the labeling of testosterone replacement therapy (TRT) products. The group called for the warning after a pair of recent studies found that testosterone boosters, which are now prescribed to nearly 3% of American men over the age of 40, may increase the risk of heart attacks, strokes, blood clots and death. However, despite these findings, a group of doctors with ties to the pharmaceutical industry has said that “Low T” treatments are safe, and may actually help prevent heart attacks.
Free Testosterone Lawsuit Evaluation: If you or a loved one was injured after undergoing testosterone replacement therapy (TRT), you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the testosterone supplement and we can help.
What’s the Problem?
Public Citizen is a consumer advocacy group that raises awareness about potential risks associated with prescription drugs that may not be adequately disclosed on their labeling. In a petition filed with the U.S. Food & Drug Administration (FDA) on February 25, 2014, the organization requested a black box warning to raise awareness about the cardiovascular risks associated with testosterone boosters.
“We hereby petition the FDA to add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S.” the letter says. “We urge the FDA to ask manufacturers to send “Dear Doctor” letters to warn physicians of these serious adverse effects and to require that the FDA-approved Medication Guide for testosterone products, dispensed to patients when their prescriptions are filled, be updated to include this new warning.”
Androgen Study Group
The Androgen Study Group includes a number of doctors who are urging the FDA to reject Public Citizen’s petition to include a boxed warning on labels of TRT products. The group opposes the new warnings and feels the petition is based on weak studies with no scientific merit.
Studies Link Testosterone to Cardiovascular Risks
In November 2013, a study published in the Journal of the American Medical Association (JAMA) suggested that older testosterone users, as well as younger ones with a history of heart disease, had an increased risk of suffering heart attacks, strokes and sudden death. This study was followed two months later by research published in the medical journal PLOS ONE which determined that Low T treatments may double the risk of heart attack for young men with a history of heart disease, as well as for men over the age of 65 with no heart problems. After reviewing these studies, the FDA announced that it had launched an investigation into the safety of testosterone supplements.
Androgen Study Group: Strong Ties to Pharmaceutical Industry
The Androgen Study Group was formed as a result of what it considers “unnecessary” concerns about the safety of TRT. While the group portrays itself as independent and dedicated to the fair treatment of testosterone supplementation, in reality it consists of doctors and scientists with ties to the pharmaceutical industry, including manufacturers of best-selling testosterone boosters.
In March of 2014, the Androgen Study Group demanded that JAMA retract its study, which the journal refused to do. In response to Public Citizen’s petition, the group suggests that it is not based on any research that indicates an increased risk of cardiovascular health complications. The Androgen Study Group believes that Public Citizen has ignored earlier studies which show a strong relationship between cardiovascular side effects and Low T, as well as indications that TRT improves cardiovascular risk factors.
The Androgen Study Group contends that it is independent, and that its members own no stock in testosterone supplement companies. What is not stated is that almost all the doctors in the group have ties to Auxilium Pharmaceuticals, the company that makes Testim and Testopel, two of the best-selling testosterone boosters on the U.S. market today.
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 side effects cases in all 50 states.
Free Testosterone Lawsuit Evaluation: If you or a loved one was injured after using 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.