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Federal drug regulators are requiring the manufacturers of AndroGel, Testim, Axiron, Depo-Testosterone and others “Low T” drugs to add new warnings about the link between blood clots and testosterone replacement therapy, including an increased risk of deep vein thrombosis (DVT) or pulmonary embolism.
On June 19, the FDA indicated that additional information about the risk of blood clots will be added to testosterone drug labels, indicating that the medications may cause venous thromboembolism (VTE).
The statement comes as the FDA continues to investigate the potential link between testosterone and heart problems, following studies earlier this year that suggested men using the “Low T” drugs may face an increased risk of heart attacks, strokes and death.
Side effects of testosterone therapy were already known to increase the risk of blood clots due to a problem called polycythemia, an abnormal increase in red blood cells. However, the FDA now reports that it has found reports of blood clots above and beyond those linked to polycythemia. The new label warning changes the existing blood clot warning from one linking the problem to polycythemia, to a more generalized VTE warning.
Venous thromboembolism are blood clots that occur in the veins. They can lead to painful clots in the legs, known as deep vein thrombosis (DVT), or they can break off and flow to the heart and lungs, resulting in a pulmonary embolism, which can sometimes be deadly.
The FDA warning notes that these blood clots appear to be a different problem than those that may be causing testosterone users to suffer heart attacks and strokes.
An investigation into the cardiovascular risks associated with testosterone drugs was launched by the FDA on January 31, following at least two studies that raised concerns about the safety of the widely used and aggressively promoted medications.
In November 2013, a study published in the Journal of the American Medical Association (JAMA) found that certain men with pre-existing heart problems may face an increased risk of heart attacks, strokes and death from testosterone drugs.
That research was followed by a study published in the medical journal PLOSOne in January 2014, which found that side effects of low T treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.
Following the studies and the launch of the FDA investigation, a growing number of AndroGel lawsuits, AndroDerm lawsuits, Testim lawsuits, Axiron lawsuits and other products have been filed by men throughout the United States, alleging that inadequate warnings were provided about the risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis and wrongful death.
Most of the lawsuits filed to date have involved injuries associated with the use of AndroGel, which is the most widely used testosterone gel spray manufactured and sold by AbbVie. However, earlier this month a panel of federal judges consolidated all testosterone drug lawsuits filed in federal courts nationwide into the Northern District of Illinois for pretrial proceedings as part of a testosterone NDL, or multidistrict litigation.