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European and Australian researchers warn that the side effects of testosterone replacement therapy, which includes popular drugs like AndroGel, Testim and Axiron, may cause an increased risk of blood clots during the first six months of treatment.
In a study published this week in the medical journal The BMJ, researchers indicate that testosterone treatment appears to increase the overall risk of blood clots by 25%.
The testosterone treatment blood clot risk appears to peak during the first six months of treatment, particularly for men without medically proven hypogonadism, increasing recent concerns about many men who use the drugs without a true medical need.
Use of testosterone drugs among aging men has increased dramatically in recent years, amid aggressive marketing by drug makers, which encourage men to seek treatment if they experience symptoms of of a made-up medical condition known as “low T”, such as reduced energy levels, strength, sex drive or other symptoms commonly seen among most men as they get older.
Over the past few years, concerns have emerged about the unnecessary health risks associated with testosterone treatments, which have also been linked to an increased risk of heart attacks, strokes and wrongful death. As a result, experts and federal regulators have cautioned that the drugs should only be prescribed to men experiencing testosterone deficiencies caused by medical condition, such as hypogonadism.
In this latest study, researchers looked at data on 19,215 patients with confirmed blood clots, or venous thromboembolism (VTE), and compared them to 909,530 age-matched controls.
They found that, overall, men taking using testosterone replacement therapy were 25% more likely to suffer a blood clot than men who did not use testosterone. However, in the first six months of testosterone treatment, the increased risk was 63% higher. For men without pathological hypogonadism, who critics say should not be using testosterone treatment, the six-month increased risk was 88%.
“This study provides the first evidence for a differential in an adverse effect of testosterone treatment in men with and without pathological hypogonadism, which peaks in the first six months and declines thereafter,” the researchers wrote.
The study came about a month after the FDA issued a warning about the risk of abuse and dependence on testosterone drugs and other anabolic androgenic steroids and announced the drugs would carry new label warnings.
Testosterone Treatment Lawsuits
The findings may provide further support for many Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone treatment lawsuits pending in state and federal courts nationwide, which allege that the drug makers failed to provide adequate warnings for consumers and the medical community.
Given the similar allegations raised in the lawsuits, more than 6,000 cases filed throughout the federal court system have been consolidated for pretrial proceedings as part of a multidistrict litigation (MDL), which is centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois.
As part of the coordinated proceedings, a series of Androgel trials are expected to begin in June 2017, which are designed to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
If testosterone treatment settlements are not reached following bellwether trials in the MDL, the drug makers may face hundreds of individual trial dates in U.S. District Courts nationwide over failure to warn about the heart risks associated with their medications.