The FDA is investigating the risk of heart attack, stroke and death among men taking different forms of testosterone therapy. This announcement came after two recent studies, one published in PLOS One, and the other in the Journal of the American Medical Association (JAMA).
History of Testosterone Therapy Treatments
Three pieces of research helped set a “scientific framework” for testosterone therapy according to the Urological Sciences Research Foundation. In 1849, Arnold Berthauld found that when roosters were castrated they stopped mating, crowing and fighting. He found that behavior came back with the testes.
In 1889, 72-year-old Charles-Edouard Brown-Sequard, claimed he had “rejuvenated” himself with testicular extract he injected from guinea pigs. But, it was found that he was experiencing an “apparent placebo effect,” since no androgen was found in that extract.
Then, in 1944, two internists found that some older men were developing symptoms related to hypogonadism, a disease where the body stops producing the hormone naturally.
Later in 1992, the FDA proposed a form of natural testosterone using a transdermal scrotal film, followed by non-scrotal skin patches.
The first testosterone gel was approved in 2000 by the FDA. Doctors said the gel offered patients a non-painful alternative over injections. AndroGel, manufactured by AbbVie Inc., gave patients a constant level of testosterone. It is prescribed to men who have low or no testosterone due to age or hypogonadism, a disease where the body stops producing the hormone naturally. The gel is available in two forms: Androgel 1%, and Androgel 1.62%.
A study was conducted at that time involving 227 men with low testosterone levels. It determined that out of 129 of them who had testosterone blood levels checked and doses adjusted, 87% of them returned to “normal levels” of testosterone.. The only side effects found at the time were: acne, prostate and urinary problems, swelling and skin reactions to the gel.
When to Seek Treatment
Only a doctor will be able to determine if you need testosterone therapy. Never stop or start testosterone therapy treatment unless instructed to do so by your physician.
If you have suffered or are suffering serious side effects including heart attack, stroke, blood clots or the death of a loved one after using a form of testosterone therapy, you also need to contact your doctor and the FDA.
You could be entitled to a testosterone therapy lawsuit.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.