Recently, the FDA received a letter related to adding a low testosterone warning to the label of the prescription testosterone therapy products on the market. The 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.”
The petition goes on to cite many studies and several that show that it appears that there may be an increased of cardiovascular events in men on low testosterone “low t” therapy. Some of the most recent studies published on NIH in 2012 and 2013 and others. Furthermore, the petition states that out of the 27 studies conducted, may were funded by the drug industry itself.
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. And, the petition goes on to further state that “despite all of these studies, the FDA stated on Jan. 31 that it “has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”
Recently, the Endocrine Society called for more low testosterone studies to be conducted in low T or low testosterone therapy because it may be causing problems in men.
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
- Death
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.
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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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