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Recent Posts in Testosterone Therapy Category

  • TRT Manufacturer AbbVie Unable to Avoid Bellwether Trials

    On May 8, 2017, US District Judge Matthew F. Kennelly ruled on several matters regarding the upcoming MDL bellwether trials ( In e: Testosterone Replacement Therapy Products Liability Litigation) . AbbVie, the manufacturer of AndroGel, had filed motions to exclude expert testimony on causation and for summary judgment in an attempt to dismiss the cases based on a lack of sufficient causation ...
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  • FDA REQUIRES MANUFACTURERS TO PUT A GENERAL WARNING ABOUT VENOUS BLOOD CLOTS RISKS WITH TESTOSTERONE PRODUCTS

    On 6/19/2014, the FDA issued a drug safety statement affecting all FDA-approved testosterone products currently on the market. According to the statement: "[FDA] is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include ...
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  • THE EUROPEAN MEDICINES AGENCY INITIATES REVIEW OF TESTOSTERONE PRODUCTS OVER CONCERNS ABOUT CARDIAC SIDE EFFECTS

    The European Medicines Agency (EMA) recently started a safety review of testosterone-containing products. The review was initiated at the request of the Estonian medicines agency due to concerns about harmful effects of testosterone therapy (TT) on the heart. These safety issues were raised in several recent publications that suggested significantly increased risk of heart attacks and other ...
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  • HARVARD MEN'S HEALTH WATCH WARNS OF CARDIAC RISKS WITH TESTOSTERONE THERAPY

    The most recent issue of Harvard Men's Health Watch discusses the safety and risks associated with testosterone therapy (TT). The newsletter notes that millions of Americans undergo testosterone therapy, enticed by the myriad promises of lifestyle improvements offered by the "ongoing pharmaceutical marketing blitz." However, there are "legitimate safety concerns linger[ing]", such as new evidence ...
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  • THE ENDOCRINE SOCIETY CALLS FOR REEVALUATION OF TESTOSTERONE THERAPY RISKS

    The Endocrine Society has issued a statement highlighting the need for robust evaluation of the risks associated with testosterone therapy (TT). In it, the Society recommends that "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." ...
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  • FDA Evaluating the Risk of Heart Attack, Stroke and Death Following Testosterone Therapy in Men

    A recent safety announcement issued by the FDA warned of safety risks associated with testosterone therapy (TT). In particular, the "FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products." Two recent publications have prompted the FDA "to reassess the cardiovascular safety" of TT. A November 2013 publication reported 29% increase in the ...
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