Testosterone replacement therapy (TRT) is used by millions of men to treat low testosterone, otherwise known as “Low T.” In fact, sales in 2012 were reportedly as high as $2 billion and this is projected to more than double before 2017. However, since 2010, information has disseminated suggesting the increase of serious side effects such as heart attacks, strokes and thrombolytic events among groups of men prescribed TRT products. These products include AndroGel, Testopel, Androderm, Striant, Axiron, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta and many more.
Subsequently, in January 2014, the FDA announced it would start investigating the risk of stroke, heart attack, and death in men taking these FDA approved testosterone products. Since then, lawsuits have been filed against at least five different pharmaceutical companies claiming injury from these products.
Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. For example, conditions when the testicles are not able to produce testosterone because of reasons such as a genetic problem or exposure to chemotherapy. Other examples include problems with the hypothalamus or pituitary gland that control the testicles’ production of testosterone.
Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. For example, conditions when the testicles are not able to produce testosterone because of reasons such as a genetic problem or exposure to chemotherapy. Other examples include problems with the hypothalamus or pituitary gland that control the testicles’ production of testosterone.
Current allegations suggest that these products were misrepresented as a safe and effective treatment for hypogonadism despite causing an increased risk of cardiovascular events. It is also alleged that manufacturers ignored these potential risks of TRT and instead utilized marketing and advertising to value sales over adequate warnings. This leads to the question; did manufacturers exploit the successful marketing of Viagra and other erectile dysfunction treatments to encourage relatively healthy men to try testosterone therapy?
Drug approval is not indicated for age-related hypogonadism, or the age-related decline of testosterone. A possible loophole that has allowed TRT usage in aging males was perhaps enabled by the inclusion in the indication of “idiopathic” hypogonadism and applying that term to age-related decline in testosterone.
Investigation is still underway and the FDA has not yet concluded that FDA-approved testosterone treatment does in fact increase the risk of stroke, heart attack, or death. Nevertheless, they are urging health care providers to consider whether the benefits of FDA approved testosterone treatment is likely to exceed the potential risks of treatment. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.
Drug approval is not indicated for age-related hypogonadism, or the age-related decline of testosterone. A possible loophole that has allowed TRT usage in aging males was perhaps enabled by the inclusion in the indication of “idiopathic” hypogonadism and applying that term to age-related decline in testosterone.
Investigation is still underway and the FDA has not yet concluded that FDA-approved testosterone treatment does in fact increase the risk of stroke, heart attack, or death. Nevertheless, they are urging health care providers to consider whether the benefits of FDA approved testosterone treatment is likely to exceed the potential risks of treatment. None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.
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