Testosterone Therapy Treatment
In June 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal testosterone replacement lawsuits into one court in the Northern District of Illinois. The goal was to improve efficiency of pre-trial proceedings, and to reduce the risk of conflicting rulings. The testosterone MDL will also help conserve judicial resources and avoid duplicative discovery.
Plaintiffs bringing lawsuits against testosterone therapy drug manufacturers claim that the drugs lacked adequate warnings about the health risks, and were defectively designed. Most suffered serious side effects after taking the drugs, including heart attack and stroke, and seek compensation to cover their medical expenses and lost wages.
Testosterone Therapy Heart Attack Risk
Testosterone therapy has been linked to an increased risk of heart attacks in male patients who use the therapies. A PloS One study published in 2014 reported that the use of testosterone therapy doubled the risk of men aged 65 and older having a heart attack. Younger men taking some form of testosterone therapy with a family history of heart disease also had three times the risk of suffering from a heart attack.
An earlier study published in JAMA in 2013 also found similar results. Researchers were so concerned, in fact, that they stopped the study early because of the number of men who were taking testosterone replacement drugs that suffered from adverse cardiovascular events like heart attacks and strokes.
What Is Low Testosterone Versus Hypogonadism?
Testosterone is a “male” hormone produced mainly by the testicles. It helps preserve a male’s sexual characteristics. According to the Cleveland Clinic, the hormone helps maintain bone density, sense of well-being, levels of red blood cells, reproductive function, and muscle. The level of testosterone in the male body reaches its peak in early adulthood or adolescence.
There is a difference between low testosterone and hypogonadism. Testosterone in all men declines with age at a rate of about 1% per year after the age of 30. Hypogonadism, on the other hand, is a disease. With hypogonadism, there is a problem with the pituitary gland or the testicles that leaves the body unable to produce normal amounts of testosterone.
• Mood changes
• Cognitive issues
• Erectile Dysfunction
• Lowered sex drive
• Decreased sense of well-being
The FDA approved the use of testosterone replacement therapies only for the treatment of hypogonadism as medically diagnosed by a doctor. Manufacturers, however, conducted an aggressive marketing campaign that led many men to believe that they needed testosterone supplements even though they weren’t diagnosed with any medical condition.
Testosterone Therapy Often Used Without Proper Diagnosis
Testosterone therapy, prescribed in the form of patches, gels or injections, is used to counteract the effects of inadequate testosterone production in men. Insufficient testosterone in the male body is common among middle-aged and older men according to a study in the National Center for Biotechnology Information.
The study says the number of male patients seeking a form of testosterone therapy has increased over the years. Medical professionals and the company that manufacture the testosterone therapies advise that you should always consult with your doctor before beginning any form of testosterone therapy. The FDA has approved several forms of testosterone therapy, but only for the treatment of true hypogonadism.
The fact that more and more men are taking testosterone products to treat common symptoms of aging like fatigue, muscle loss, and reduced libido has become concerning to many healthcare professionals. In a 2014 study published in the Journal of Clinical Endocrinology & Metabolism, researchers found that 40.2 percent of men did not have a testosterone test in the 180 days before beginning therapy, and 50 percent had only one test. (Doctors typically recommend more than one test to get a more accurate view of the actual testosterone levels.)
Researchers concluded that “high rates of inadequate laboratory testing” was found prior to initiating therapy in both U.S and U.K. men.
Types of Testosterone Treatment
AndroGel 1%, manufactured by AbbVie, is applied to the shoulders, abdomen or upper body. The FDA recommends men wash the area of skin treated with AndroGel to protect others from cross-contamination. The FDA states that children who are exposed to the gel can have early symptoms of puberty.
Another gel, Testim 1%, manufactured by Auxilium Pharmaceuticals, Inc. also comes with a new warning label from the FDA on “secondary exposure.” This gel can also cause the early on-set of puberty in children, and facial hair and acne in women.
Axiron, is a topical gel used to treat low or no testosterone in male patients. The FDA again warns about “secondary exposure” with this drug manufactured by Lilly USA, LLC.
Other brands of testosterone therapy on the market include:
• Androderm-Watson Labs
• Android 10-Valeant Pharm Intl
• Android 25-Valeant Pharm Intl
• Axiron-Eli Lilly and Co.
• Delatestryl-Endo Pharms
• Depo-Testosterone-Pharmacia and Upjohn Inc.
• Fortesta-Endo Pharms
• Striant-Actient Pharms
• Testopel-Actient Pharms
• Testosterone Cypionate-Watson Labs, Paddock LLC
• Testosterone Enanthate-Watson Labs, Paddock LLC
• Testred-Valeant Pharm Intl
Testosterone Therapy Serious Side Effects
Several studies have brought forth the issue of testosterone therapy increasing the risk of heart issues. The most recent study was published in January 2014 in PLoS One, and is entitled “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men.” The Mayo Clinic outlines several possible side effects from taking testosterone therapy:
• Adverse skin reactions
• Breast enlargement
• Decrease in sperm production, testicle shrinkage
• Noncancerous growth of the prostate
• Contribute to sleep apnea
• Cause polycythemia (overproduction of red blood cells) which can increase risk of heart disease
The study in PLoS One was one of two that prompted the FDA to investigate the risk of heart attack, stroke and death in those patients taking a form of testosterone therapy.
On January 31, 2014, the FDA released a drug safety communication announcing that they were investigating the risk of stroke, heart attack, and death in men taking testosterone products. They reminded men and their doctors that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.” They also asked patients and doctors to report side effects to the “FDA MedWatch program.”
Contact A Testosterone Therapy Treatment Attorney Today
If you or a loved one has taken or are taking a form of testosterone therapy and experienced serious adverse effects such as a heart attack, contact our attorneys at 1-888-316-2311 or via email to discuss your options. There are statutes of limitation in each state, which limit how long you have to bring a lawsuit if you are injured, so call now.
Please remember to seek medical treatment and discuss the best course of action with your doctor before discontinuing use of any testosterone therapy.