Androderm is a topical testosterone replacement therapy medication available as a patch to be applied to the skin. It is approved to for the treatment of low testosterone levels in men with hypogonadism who are unable to make enough testosterone.
Androderm and other testosterone replacement medications were aggressively marketed for “Low-T”, an unapproved condition. Many men who used Androderm patch may have used it for normal symptoms of aging and were never tested for low testosterone levels.
Use of Androderm may have unnecessarily increased the risk for:
- Blood clots
- Heart attack
- Pulmonary embolism
Androderm manufacturer, Allergan and its subsidiary, Actavis was the target of thousands of Androderm lawsuits filed by men and loved ones of those who were harmed by use of testosterone medication. Androderm lawsuits claimed that Allergan inappropriately marketed their medications and knowingly put men at risk of deadly side effects.
In July of 2018, Allergan reached at settlement to resolve about 500 Androderm lawsuits. Androderm lawsuits had been filed on behalf of men or their family members after Androderm use may have resulted in serious side effects, including some deaths.
Androderm lawsuits were part of a large multidistrict litigation (MDL) case which may have included as many as 8,000 individuals at one time. Like the Androderm lawsuits, many of the other testosterone lawsuits have been resolved through settlements, though some may still remain in court systems.
Androderm patch is approved to treat low testosterone levels that occur due to hypogonadism, but thousands of men may have used the treatment for “Low-T” to combat normal signs of aging such as decreased libido, lack of energy and muscle loss. Unfortunately, like other testosterone replacement treatments, Androderm has been shown to cause serious side effects.
Lawsuits filed against Allergan and its subsidiary Actavis, have claimed that use of Androderm patch has resulted in severe medical injuries including:
- Heart attack
- Pulmonary embolism
- Blood clots
- Deep vein thrombosis
- Venous thromboembolism
Thousands of men who used Androderm patches and experienced serious injury, have filed Androderm lawsuits against Actavis and its parent company, Allergan.
Androderm is a patch formulation of testosterone which is approved as replacement therapy for males whose bodies do not manufacture enough testosterone, a condition known as hypogonadism.
Many men who took testosterone for symptoms of Low-T such as decreased sex drive, low energy, loss of muscle mass and foggy thinking, were experiencing normal symptoms of aging and not a medical disorder. A large percentage of men who used testosterone therapy have never had their hormone levels verified but were subject to increased risk of life-threatening side effects with no clear evidence for use.
Manufacturers of Androderm and other testosterone products have been accused of failing to warn the public about the risks of testosterone replacement therapy and encouraging the use of the hormone to improve symptoms of “Low-T”. Low-T is not an approved indication or reason to use testosterone, but a marketing term.
Androderm FDA Warnings
In January of 2014, after two large studies linked testosterone replacement therapy to an increased risk of heart attack and other cardiovascular events, the Food and Drug Administration (FDA) issued a safety warning indicating that they were beginning an investigation regarding the risks. This announcement was followed in mid-2015 with a requirement that all testosterone replacement products including Androderm gel and Androderm patch add safety warnings about the risk of heart attack, stroke and other cardiovascular events.
Separately, in June of 2014, the FDA also required that manufacturers add safety information about an increased risk of clotting disorders such as deep vein thrombosis (DVT) and venous thromboembolism (VTE). The risk of heart attack, blood clotting, stroke and other life-threatening events may be as much as two to three times greater when testosterone replacement therapy is used and is particularly notable during the first six to nine months of treatment.
Allergan and its subsidiary, Actavis, announced in July of 2018 that they had reached a tentative settlement agreement to resolve around 500 Androderm lawsuits. The cases to be settled were part of a larger group of around 8,000 federal testosterone lawsuits which had been consolidated into multidistrict litigation (MDL). The lawsuits had been filed against a number of manufacturers for improper marketing practices which promoted the products for “Low-T” and concealed the serious risks of testosterone replacement therapy.
Terms of the settlement offer were not been publicly disclosed and more lawsuits may be expected but men or loved ones of those who were harmed by Androderm should seek legal advice.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use, (3/2015)
- Actavis Agreed On Global Settlement for About 500 Androderm Lawsuits, Neural IT (7/2018)