The U.S. Food and Drug Administration (FDA) is requiring the manufacturers of testosterone products like AndroGel, Axiron and Testim to add new warnings to their drug labels regarding their connection to blood clots and life-threatening side effects like pulmonary embolism and deep vein thrombosis (DVT). The FDA statement comes as the agency continues to investigate the potential link between low T treatments and heart problems, after studies published earlier this year found that users of testosterone products may face an increased risk of stroke, heart attack and death. If you or a loved one has suffered injuries allegedly linked to a testosterone treatment, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a qualified TRT injury attorney today.
The FDA announcement came on June 19, and indicated that additional information about the increased risk of venous thromboembolism (VTE) would be added to testosterone replacement therapy (TRT) drug labels. Side effects of TRT have already been known to increase a patient’s risk of blood clots due to an abnormal increase in red blood cells – called polycythemia – but new reports indicate that testosterone treatments may be linked to blood clot problems above and beyond polycythemia, which is why the new drug labels will include a more generalized VTE warning. Venous thromboembolism occurs when painful blood clots form in the legs (deep vein thrombosis) or they break off and travel to the heart and lungs (pulmonary embolism).
An investigation into the cardiovascular risks of low T medications was launched by the FDA earlier this year, after at least two studies found an increased risk of heart problems among certain men using testosterone replacement therapy. The first study, published in November 2013, found that some men with pre-existing heart problems may face an increased risk of heart attack, stroke and death from testosterone drugs. Another study, published in January 2014, found that testosterone treatments may double the risk of heart attack for younger men with heart disease, and for men 65 and older, regardless of any previous heart conditions.
In light of the risk of cardiovascular side effects tied to testosterone replacement therapy, a growing number of product liability lawsuits are being filed against the makers of testosterone drugs like AndroGel, Testim and Axiron. All of the TRT lawsuits involve similar allegations that the manufacturing companies failed to provide adequate warnings to consumers and the medical community about the risk of stroke, heart attack, deep vein thrombosis, pulmonary embolism and wrongful death associated with low T treatments. If you believe you have been adversely affected by side effects of TRT, contact an experienced product liability lawyer today for legal help.
[box type=”note” align=”aligncenter” ]Source: http://www.fda.gov/Drugs/DrugSafety/ucm401746.htm[/box]