Tuesday, May 27, 2014

Have You Been Harmed By the Testosterone Drug Fortesta?

Recent study conclusions regarding testosterone supplements have many men worried whether they may suffer a serious adverse health risk as a result of the testosterone supplement they are currently taking. A study published in the Journal of American Medical Association found a 29% increase in heart attack, stroke and death among men taking testosterone supplements when compared with men not taking the drug. A study done by a Cincinnati doctor cautions all men considering testosterone therapy to have a simple blood test which will determine whether they have a risk for blood clots.

 

Dr. Glueck’s research found that dangerous blood clots could develop as soon as a month after testosterone therapy was begun, and that many of the men who developed blood clots in the legs or veins developed those clots within three months of beginning a testosterone drug. Another study was halted before conclusions could be reached as there were too many men in the study having heart attacks and strokes. Testosterone levels naturally decline once a man reaches the age of 30, about 1-3% per year. Testosterone manufacturers are aggressively marketing testosterone drugs, implying they are a veritable fountain of youth. Advertisements for testosterone state the following “symptoms” of Low-T as being sufficient to request a prescription for testosterone:

 

·         Loss of libido

·         Erectile dysfunction

·         Weight gain in the belly region

·         Decreases in muscle mass

·         Decreases in strength

·         Decreases in bone density

 

While these symptoms are certainly related to hypogonadism—a medical condition which results when the body stops producing testosterone altogether—they are also the normal effects of aging. Recent data from the Massachusetts Male Aging Study notes that approximately 2.4 million men between the ages of 40 and 69 suffer from hypogonadism. Assuming every single one of these men have a prescription for testosterone, that leaves another two and a half million men from the annual 5 million prescriptions written for testosterone, who don’t have a valid medical condition, yet are still taking testosterone supplements.

 

It is highly likely that these men have no idea of the potential risks associated with testosterone supplements. While doctors are not entirely sure why testosterone may lead to stroke, heart attack, deep vein thrombosis and pulmonary embolism, the theory is that testosterone drugs lead to excess blood clotting. In older men particularly, the walls of the veins have thinned, making them more susceptible to an adverse cardiovascular event.

 

The Potential Risks of Fortesta

Endo Pharmaceuticals is the manufacturer of Fortesta, which received FDA approval on December 29, 2010. Fortesta is a gel which is applied topically; the dosage depends on how much is applied. The insert which accompanies Fortesta notes “There are insufficient long-term safety data in geriatric patients using Fortesta to assess the potential risks of cardiovascular disease and prostate cancer.” Warnings for Fortesta include edema, with or without congestive heart failure, sleep apnea, an increase in PSA levels, fluid retention, polycythemia, eye disorders, gastrointestinal disorders, fatigue, flu-like symptoms, dizziness, headache, migraines and issues with the reproductive system. Endo Pharmaceuticals conducted a 90-day clinical study among 149 hypogonadal patients who were treated with Fortesta. Adverse reactions occurred in 22.8% of the study participants. Unfortunately, this study included far too few participants and included no participants without a medical diagnosis of hypogonadism. If you or a loved one feel you have suffered harm after taking a testosterone drug, speaking to a testosterone injury lawyer can be beneficial. There are currently five lawsuits filed against one manufacturer of testosterone, and many more are expected.

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