Axiron Lawsuit – Risks & Side Effects

Axiron is a type of testosterone replacement therapy which was aggressively promoted for Low-T conditions when it may not have been needed. Multiple Axiron lawsuits have been filed against Eli Lilly for heart attack. stroke and other life-threatening injuries that may have been caused by the topical testosterone replacement product.

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Quick Summary

Axiron Lawsuit

Axiron is a popular topical testosterone replacement therapy medication approved to treat low testosterone levels in men with hypogonadism. Like many other brands of testosterone, Axiron was marketed for “Low-T” and men who used Axiron may have used it for normal symptoms of aging and never had their testosterone levels tested.

Axiron may have increased the risk for:

  • Blood clots
  • Heart attack
  • Stroke
  • Pulmonary embolism
  • Death

Axiron’s manufacturer, Eli Lilly has been the target of multiple Axiron lawsuits which claim the company knowingly put consumers at risk of serious side effects and inappropriate marketing.

Axiron Settlement

Men who experienced serious side effects and family members of men who died after using testosterone replacement medications like Axiron, have filed lawsuits against Eli Lilly and other manufacturers. Axiron lawsuits were part of a number of multidistrict litigation (MDL) cases but in December of 2017, Eli Lilly announced that they were settling about 400 Axiron cases for undisclosed amounts. As thousands of men used testosterone replacement products for Low-T, companies may still be facing more lawsuits.

Axiron, a topical form of testosterone replacement therapy, is approved to treat the medical condition, hypogonadism however, it has been prescribed to thousands of men to combat the natural signs of aging such as loss of muscle mass, decreased libido and fatigue. Testosterone manufacturers used compelling advertisements which promoted testosterone replacement therapy products for “Low-T”.

Low-T is not a diagnosis but a marketing message and many men who used testosterone products like Axiron, were never tested for low testosterone levels and may have been experiencing normal symptoms related to aging.

These men may have been placed at risk for serious adverse events including:

Many men who experienced serious side effects and family members of men who died after using testosterone replacement medications like Axiron, have filed lawsuits against Eli Lilly and other manufacturers.

Axiron FDA Warnings

Safety concerns arose when researchers published the results of two large studies which indicated that testosterone replacement may increase the risk of heart attack, stroke and other life-threatening events by two to three times that of men not taking testosterone. This prompted the Food and Drug Administration to issue a January 2014 warning announcement stating that they were investigating the safety of these products.

In June of 2014, a separate FDA warning was issued regarding testosterone’s increased risk of blood clotting episodes like deep vein thrombosis (DVT) and venous thromboembolism (VTE), which can lead to life-threatening events. The warning included a notice that labeling would be required to include clotting information and in mid-2015, the FDA required that labeling again be updated to include the potential risk of heart attack, stroke and other serious events.

Axiron Settlement

Thousands of testosterone lawsuits have been filed against a number of testosterone product manufacturers. The majority of these cases were federal lawsuits that were consolidated into multidistrict litigation but in December of 2017, Eli Lilly settled about 400 Axiron lawsuits that had previously been part of the federal multidistrict litigation (MDL) case.

Based on the negotiations, pending trial dates for Axiron lawsuits were set aside and though an agreement was reached, no details were publicly announced. In addition to the federal lawsuits that may have been settled, Lilly may still be facing other lawsuits in state and local courts and more may be expected.

Past medical injury lawsuits or settlements have provided compensation for medical costs, lost wages, pain and suffering or for wrongful death if the injury victim has died. Axiron risks may have included:

  • blood clots
  • heart attack
  • stroke
  • pulmonary embolism
  • death

Men or loved ones of those who suffered from complications while using Axiron should seek legal advice.

Read more about testosterone lawsuits.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.