Earlier In February 2014 The Endocrine Society Of Medical Doctors Urged Caution In The Prescribing Of These Products To Certain Middle-Aged And Older Men
(Posted by Tom Lamb at DrugInjuryWatch.com)
On February 25, 2014 a so-called Citizen Petition was filed with the FDA requesting that a "Black-Box" warning about the increased risks of heart attacks, strokes, and other cardiovascular dangers, including cardiac deaths, be added immediately to the drug labels of testosterone replacement therapy (TRT) products such as AndroGel, Axiron, and Testim.
From this February 2014 document filed by the Public Citizen group, "Petition to the FDA for Black Box Warnings on all Testosterone Products" (PDF format):
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.
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....
The urgency for this action is highlighted by the massive prescribing of testosterone-containing products, with more than 400,000 prescriptions filled in the U.S. in December 2013 alone and more than 5 million filled during all of 2013. [footnotes omitted]
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Less than three weeks before this FDA Petition was filed by Public Citizen as regards the safety profile of these commonly called "Low-T" testosterone drugs, a leading group of medical doctors expressed their concern about recent studies pointing to increased risks for cardiovascular events after the start on new testosterone therapy.
On February 7, 2014 the Endocrine Society issued a statement, "The Risk of Cardiovascular Events in Men Receiving Testosterone Therapy" (PDF format), which included this cautionary guidance about these increasingly popular testosterone products:
Large scale, prospective, randomized controlled trials are needed to determine the risks and benefits of testosterone therapy in older men with age-related decline in testosterone levels.
Further, the Endocrine Society statement said that until this testosterone drug-safety evidence is available:
... patients should be made aware of the potential risk of cardiovascular events in middle-aged and older men who are taking or considering testosterone therapy for age-related decline in testosterone levels and symptoms. Physicians and patients should have a conversation about the risks and benefits of using testosterone, especially in patients who have pre-existing heart disease.
We have been reporting on the recent medical studies indicating that there might be an increased risk of heart attacks or myocardial infarctions (MI), strokes (CVA), and deaths due to other cardiovascular conditions associated with the use of testosterone therapy (TT) products, as listed below:
- More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks
- The Growing Use Of Testosterone Creams, Gels, Injections, And Patches Raises Increased Concerns About Risks Of Cardiac Side Effects
- Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths
In addition, we are currently investigating possible drug injury and death legal claims against the pharmaceutical companies responsible for AndroGel, Axiron, and Testim, as well as other some of the various other testosterone creams and gels being used for testosterone replacement or "lifestyle" purposes.