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The US Food and Drug Administration has added new blood clot warnings to testosterone drugs, indicating the risk of thrombo-embolic events. Low-T supplements widely abused by men for lifestyle enhancement are now required to carry the label information about the risk of pulmonary embolism and deep vein thrombosis, two medical conditions that may lead to stroke and cardiovascular problems. A number of testosterone therapy lawsuits have been filed in the recent months claiming that plaintiffs suffered fatal and non-fatal heart disorders after receiving Low-T replacement therapy.
The FDA Warning: Testosterone Therapy Blood Clots
Issued on June 19, 2014, the latest FDA warning was expected following the January 31st decision of the federal regulator to investigate into the testosterone therapy cardiovascular risks reported by independent researchers. Two medical studies reported in November 2013 and January this year had indicated a two-fold rise in the heart attack, stroke, and death risk in men using Low-T supplements. Widespread concerns in the wake of these studies and petitions by consumer groups forced the FDA to announce a safety review of AndroGel, Testim, and similar other testosterone supplements.
The new FDA Low-T drug warning highlighted the possibility of blood clots and consequent venous thromboembolism or deadly arterial blockages caused by Low-T medications. It mentions about two types of highly dangerous blood clots – pulmonary embolism and deep vein thrombosis – as the potential side effects of testosterone replacement therapy. Deep vein thrombosis occurs when blood clots develop in a deep vein located in legs. These clots break off in due course and travel upward, blocking the main artery supplying blood to the lungs. It generates enhanced strain on the right ventricle of the heart and leads to pulmonary embolism, a life threatening condition resulting in breathing problems, reduced blood pressure, and sudden death.
Side effects of Low-T supplements leading to blood clot threats were already in the medical domain for long. These drugs are known to cause polycythemia or unusual growth in the numbers of red blood cells, a factor in ensuing blood clots. However, the pulmonary embolism warning suggests more serious and fatal adverse events linked to testosterone therapy supplements aggressively promoted by producers without informing side effects of their products.
AndroGel Lawsuits Continue To Rise
Research studies claiming heart attacks associated with Low-T drugs and FDA announcement to review the same have led to filing of a number of testosterone therapy lawsuits. AndroGel lawsuits lead the pack of testosterone litigations, while a small number of Testim lawsuits and AndroDerm lawsuits have also been filed.
AndroGel lawsuits have claimed that plaintiffs or their family members suffered from fatal and non-fatal heart disorders, including wrongful death, stroke, and thrombosis, in the absence of any information from the manufacturer AbbVie on the side effects of its testosterone gel spray. Plaintiffs blame the manufacturer for endangering public health and consumer safety for commercial gains and direct-to-consumer marketing practices. All testosterone litigations, including, dozens of AndroGel lawsuits, are centralized at the court of Illinois Northern District Judge Matthew F. Kennelly.
If you or a loved one have experienced a testosterone replacement therapy injury after undergoing low testosterone therapy, please contact our team of lawyers today for a free case evaluation at: