Recently, the FDA approved low testosterone therapy Aveed. Endo Pharmaceuticals Inc. announced today that the FDA approved low testosterone therapy AVEED™ (testosterone undecanoate) “injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone.”
According to the manufacturer, Aveed “injection is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).”
In addition, the manufacturer states that “AVEED has a Boxed Warning for serious pulmonary oil microembolism (POME) reactions and anaphylaxis. It should be used in patients who require therapy and in whom the benefits of the product outweigh the serious risks of POME and severe allergic reaction (anaphylaxis).”
The FDA ADVISORY COMMITTEE materials detail some of approval process and concerns surrounding the approval.
Recently, there have been many low testosterone low t therapy studies published on NIH in 2012 and 2013 and others. And, a recent group – Public Citizen – filed the petition for a low testosterone warning – a “black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S.”
It appears that out of the five million U.S. prescriptions for testosterone products were filled in 2013, the most common include Androgel, Axiron, Testim and Fortesta.
Testosterone was approved for the treatment of hypogonadism due to known diseases of the testes, pituitary and hypothalamus. Although the use of testosterone therapy is increasing, the treatment has not been approved for the treatment of age-related symptoms or the age-related decline of testosterone levels. The Endocrine Society has a also published a guide that outlines testosterone therapy in men.
The call for more low T or more low testosterone studies is based on the recent studies (see Low T Lawsuit ) published by NIH and the VA.
These low testosterone studies raised concerns that low T therapy or low testosterone therapy may possibly be linked to cardiovascular events in men.
Some of the potential problems that may be caused by low T or low testosterone therapy may include:
- Stroke, which occurs when a blood clot reaches the brain and restricts oxygen supply
- Pulmonary embolism, which happens when a blood clot lodges in the lungs
- Blood Clot in the Deep Veins (Deep Vein Thrombosis or DVT)
- Myocardial infarction (Heart Attack), commonly known as a heart attack – a sudden loss of blood flow in the heart
- Arrhythmia, an irregular heartbeat
- Transient ischemic attacks, or “mini-strokes,” as they are commonly called
FOR MORE ON LOW TESTOSTERONE “LOW T” THERAPY, CLICK HERE.
If you or your loved one has suffered a heart attack or stroke while on Androgel®, Androderm®, Fortesta®, Axiron®, Testim®, Bio-T-Gel®, Delatestryl®, Depo-Testosterone®, Striant®, and Testopel®– and you have any of these symptoms while on low testosterone or low t therapy and want to talk to a Low T lawyer and/or file a low testosterone lawsuit or low t lawsuit, contact us.
At the Gooch Law Firm, we pride ourselves on providing our clients reliable representation for even the most challenging cases. If you or a man you know suffered a stroke, pulmonary embolism, heart attack, stroke, death or another serious cardiac event while undergoing low testosterone therapy or low T therapy (e.g., androgel et al.) and would like your case evaluated, contact our office at 1.844.329.5955.
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