• Regulatory NewsRegulatory News

    FDA Adopts New Warning on Abuse and Dependence to Prescription Testosterone

    The new labels for all prescription testosterone products include a new warning and an updated Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS).  Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are approved for use in men wh...
  • Regulatory NewsRegulatory News

    New Blood Clot Warnings Added to Labels of Testosterone Products

    The US Food and Drug Administration (FDA) yesterday said it will require manufacturers of testosterone products about an increased risk of venous blood clots, known as venous thromboembolism (VTE)—the latest warning for a class of drugs that has seen no shortage of scrutiny from regulators and researchers alike. Background Testosterone products, commonly used to treat low levels of testosterone in men, or "low-t," have long been associated with higher risks of so...
  • EMA Initiates Review of Low-T Medications

    The European Medicines Agency's (EMA) has announced it will initiate a review of testosterone-containing medicines following concerns that the drugs, used primarily to treat a condition commonly known as "Low-T," may cause an elevated risk of cardiovascular side effects. Background Those concerns were first raised by the US Food and Drug Administration (FDA) in February 2014 following the publication of two separate studies in the Journal of the American Medical Asso...
  • Endo's Aveed Approved by FDA, Drawing Anger from Consumer Group

    US regulatory officials today approved Endo Pharmaceuticals' testosterone replacement therapy drug Aveed (testosterone undecanoate), ignoring a petition submitted last week by a consumer group that claimed the agency should first conclude a safety review of alternative products. Background FDA recently initiated a safety review of testosterone replacement therapy drugs-more commonly known as "Low-T" drugs-after several studies raised concerns about their cardiovascular ...
  • Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed

    Less than a month after US regulators issued a preliminary warning about the cardiovascular risks associated with products intended to treat low testosterone levels in men, a prominent consumer advocacy group is calling on the US Food and Drug Administration (FDA) to add more serious warnings to the products. Background FDA's review of the products, commonly known as "low-T" drugs, was triggered by two separate studies. The studies, in the  Journal of the American...