By Marilyn T.  McGoldrick, Esq. Posted on Mar 4, 2015 The FDA has announced two important changes to the labeling of testosterone replacement (LowT) products. First, the makers of testosterone replacement medication must change the labels to make clear that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical… Read More

Posted by Marilyn McGoldrick on Sep 19, 2014 12:11:00 PM A panel of experts appointed to advise the FDA voted 20-1 this week to recommend the FDA warn consumers that testosterone treatments have not been shown to reverse common problems of aging like low libido, muscle loss or energy levels. Testosterone drug makers have been… Read More

The FDA announced that it is requiring manufacturers of Low Testosterone (Low T) replacement products to add a warning to the product label of the risk of developing venous blood clots. Based on post-market reports of venous blood clots in the absence of polycythemia, the FDA will now require a general warning to men who use Low-T products that they may develop venous thromboembolism (VTE), including deep vein thrombosis (DVT), when venous blood clots form deep within the body, or pulmonary embolisms (PE), when those blood clots break off and travel towards the arteries in the lungs.… Read More

Posted by Marilyn McGoldrick on Jun 12, 2014 11:51:51 AM You may have heard a radio or television advertisement targeting men concerning a condition known as “Low T” – shorthand for low testosterone.  The ads sell testosterone replacement therapies as a way of combating “Low T.”  The ads list “symptoms” of the condition that commonly… Read More