On March 4, 2015, we published “Testosterone Drug Safety Communication 2015“, which explained and highlights the most recent communication from the U.S. Food & Drug Administration (FDA) regarding the use of Testosterone Therapy and potential risk of death, heart attacks or strokes reflected in past studies. The FDA’s Drug Safety Communication – “Testosterone Products: Drug Safety Communication – FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack and Stroke” was a follow up to a prior communication on the same subject. The FDA has advised that health care professionals prescribe testosterone therapy only for men with low testosterone level caused by certain medical conditions and confirmed by laboratory tests.
While it does not say – do not use testosterone for “off label” non-approved uses it is clearly implied. In fact, the boom in use of testosterone products is only explainable by the “off label” uses of these products to treat conditions that clever marketing has come to associate with middle age. Again, we have previously explained this marketing phenomena in the following posts: “Testosterone Drug Safety Communication 2015“, “Testosterone Lawsuits – Therapy Risks Give Rise to Lawsuits & FDA Warning“,”Manopause and Low T Therapy – A Generation of Men at Risk” and “Low T, Manopause Therapy Linked to Deaths & Complications“.
The FDA is requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. Further, the FDA has advised health care professionals that they should make patients aware of this possible increased risk. Finally, the FDA is requiring that manufacturers conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists and attempt to work together in this endeavor.
As a result, the FDA encourages patients to immediately seek medical attention if they have any of the following symptoms, which are consistent with a heart attack or stroke:
As if scripted by a Hollywood screen writer, the day following the FDA taking action on this subject, and after a year of many watching and waiting, a news release heralded ‘new’ science on the subject. This reminded me of how Tobacco manufacturers (in their 1954 A Frank Statement) concocted a “scientific debate” and flooded the public air waves with information that conflicted with information from public health authorities and the Surgeon General. Millions were none the wiser and some remain in the dark even today about how so many were duped into smoking and addiction.
In “Early Studies See No Heart Risk From Testosterone Therapy“, HealthDay Reporter, Dennis Thompson, reported that a yet unpublished, and yet to be peer reviewed study, supports the notion that testosterone therapy does not appear to cause adverse cardiovascular events. Early results of this study are to be discussed at an upcoming American College of Cardiology (ACC) annual meeting in coming days. Whether the studies or principal authors have ties to the pharmaceutical industry and manufacturers remains to be determined.
Regardless, the fact of the matter remains that Low T, or testosterone therapy, for treatment of middle aged fatigue, lack of libido or aging, is not an FDA approved indication. The FDA has issued their warning but it appears that some “scientific debates” are likely to continue as the industry circles scientists to defend continued use of their products where there are no long term clinical trials or studies. As a result, we expect that Low Testosterone lawsuits over deaths, heart attacks and strokes will continue as any claimed debate rages lingers moving forward.
Testosterone lawsuits will continue under investigation as the products have clearly been over promoted and over marketed beyond the original scope of use or approval by the FDA. Our office continues to evaluate lawsuits involving the use of testosterone products, Low T Lawsuits, Low T Heart Attacks, Low T Strokes and Low T Deaths that pre-date any label changes. Please call (954) 524-2820 to initiate a consultation or e-mail [email protected]