TESTOSTERONE THERAPY WARNING & UPDATE FROM FDA

by Gabriel F Zambrano

TESTOSTERONE DRUG SAFETY COMMUNICATION 2015

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Increased Risk of Heart Attack & Strokes 

We previously wrote about emerging data that provided safety signals and red flags over the increased use of testosterone therapy products for symptoms of “Manopause” in the following: “Testosterone Lawsuits – Therapy Risks Give Rise to Lawsuit & FDA Warning” and “Manopause and Low T Therapy – A Generation of Men at Risk“. We also posted on LinkedIn here – “Low T, Manopause Therapy Linked to Death & Complications“.  Fueled by over zealous marketing, as well as an appeal to men interested in renewing their lost youth and energy, the pharmaceutical industry has created a niche for “Low T” Testosterone Therapy. Science, lawyers and government regulators have caught up with the marketing and manufacturers.

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LOW T – FDA UPDATE 2015

On March 3, 2015, the U.S. Food & Drug Administration, (FDA), issued an updated “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 & Stroke” and mandate that all manufacturers update their labeling to emphasize approved uses for testosterone therapy medications. This mandate includes an added warning or information about the potential for an increased risk of heart attacks and strokes in patients taking testosterone products. Previously, during January 2014, the FDA had issued “Testosterone Products: Drug Safety Communication – FDA Investigating Risk of Cardiovascular Events” which notified the industry and prescribers that they were going to reassess safety issues and emerging studies that linked testosterone products to increased risk of stroke, heart attack and death.

While the FDA has taken action, after a year of evaluating science and information from the manufacturers of testosterone products, their approach to increasing awareness and warning consumers is only a step toward protecting consumers. How warnings are emphasized and communicated moving forward will help in protecting consumers. Whether manufacturers will remove direct to consumer advertising themes that target consumers or simply reinvent their campaigns will likely be watched carefully by all interested parties.

We continue to investigate cases and offer confidential case evaluations regarding “LOW T” related deaths, heart attacks or strokes. Please call (954) 524-2820 to initiate a consultation or e-mail [email protected]

FREE EVALUATION

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