AndroGel Testosterone Replacement Therapy and Heart Attack & Stroke Risks
Did you use AndroGel testosterone replacement therapy and suffer a heart attack or stroke while using the medication? Did you suffer pulmonary embolism (blood clot traveling to the lungs) or deep vein thrombosis (DVT), which are blood clots typically found in the legs? Did a loved one die as a result of AndroGel use? If so, you may be entitled to financial compensation due to the drug manufacturer’s failure to provide adequate warning of these risks to patients.
What is AndroGel?
AndroGel is a synthetic form of testosterone used to correct hormonal deficiencies in men. However, while synthetic testosterone may be used by doctors to treat hypogonadism, a medical condition, many purveyors of testosterone replacement products have marketed synthetic testosterone, like AndroGel, as a treatment for “low testosterone,” or “Low T.” The clinical significance of “low testosterone” may be questionable when the average levels of a young man are compared to the levels of testosterone measured in an older man, when testosterone levels naturally lower with age. Purveyors of “Low T” treatment have argued that this condition can reduce sex drive, energy levels and even muscle mass. However, certain studies indicate that many men do not actually have a clinical or medical need for testosterone replacement therapy. These studies also suggest that use of the AndroGel may contribute to high risks of the above-mentioned complications.
Testosterone replacement therapy has become big business for pharmaceutical firms. In fact, AndroGel, AndroDerm, Axiron and many other “Low T” replacement therapies generated over $1.9 billion dollars in sales in 2012. This is an increase in usage of over five times from the year 2000 to 2011. Testosterone replacement therapy comes in many forms and under many brand names:
- Testosterone Gel: AndroGel, Axiron, Bio-T Gel, Foresta and Testim
- Testosterone Patch: AndroDerm
- Testosterone Injection: Delatestryl, Depo-Testosterone
- Testosterone Implant: Testopel
- Testosterone Pill: Striant
Testosterone Replacement Therapy and Cardiac Risks
In November 2013, the Journal of the American Medical Association (JAMA) published a study on the increased risks of stroke, heart attack and even death involved with the use of testosterone replacement drugs. The study was conducted by researchers at the Veteran Affairs Eastern Colorado Health Care System in Denver, Colorado.
The researchers found that cardiovascular events, such as stroke and heart attack, occurred in 25.7% of those men on some form of testosterone replacement therapy. Those studied who did not take any form of testosterone replacement therapy showed cardiovascular events in 19.9% of the group. Within 18 months, of the 1,223 participants taking testosterone replacement therapy, 33 experienced strokes, 23 had heart attacks and 67 died.
The U.S. Food and Drug Administration (FDA) got involved early in 2015. The agency issued a drug safety communication on March 3, 2015 that stated, in part:
“Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. Health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose.
Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as:
- Chest pain
- Shortness of breath or trouble breathing
- Weakness in one part or one side of the body
- Slurred speech”
The FDA also required that a new warning be placed on labels for all prescription forms of testosterone replacement therapy. The new warning was designed to advise doctors and patients that using testosterone replacement therapy might increase the risk of cardiovascular events, including strokes and heart attacks.
The agency also required that warning labels be updated to say that testosterone replacement therapy drugs are approved only for treating men with an official diagnosis of hypogonadism, confirmed by at least two testosterone serum tests. In addition, the FDA required all pharmaceutical companies producing testosterone replacement drugs to perform new clinical trials to better understand the cardiovascular risks associated with the drugs.
The agency became involved again in August 2015 when it asked companies to provide proof that testosterone replacement therapy helped men who were not diagnosed with “classic hypogonadism (i.e., those who were experiencing the natural aging process) without a corresponding increase in the risk of cardiovascular events. The FDA suggested that the companies work with each other on new clinical trials based on a study published by the New England Journal of Medicine.
Some researchers have expressed concern over secondary exposure to testosterone replacement drugs, specifically the gel form of the drug. The gel is usually applied to the shoulders, upper arms or abdomen, all places that could increase the chances that women and children may come into accidental contact with the gel. The side effects of secondary exposure in children include aggressive behavior, changes in body hair distribution and sexual organs, early puberty, increased libido and advanced bone aging.
Testosterone Replacement Therapy and Blood Clot Risks
Studies have also shown that “Low T” treatments such as AndroGel may increase the risk of blood clots, some of which can be serious and even life-threatening. The worst-case scenario is the potential for men to develop deep vein thrombosis (DVT), which are blood clots found in the deeper veins of the legs. If a DVT breaks free, it could reach the lungs causing a pulmonary embolism (PE). PE occurs when one of the arteries in the lungs is blocked.
Symptoms of DVT include:
- Redness in the leg
- Swollen leg
- Leg pain
- Unusually warm leg
Symptoms of PE include:
- Chest pain, especially when inhaling
- Shortness of breath
- Coughing up blood
- Rapid breathing rate
- Rapid pulse
- Mild fever
- Unusually low blood pressure
- Loss of consciousness
- Low blood oxygen levels
- Sudden death
In June 2014, the FDA corrected a long-held misunderstanding in the warning labels for testosterone replacement drugs. The possible connection between the drugs and blood clots was common knowledge; however, the previous warnings suggested that it was likely due to a condition known as polycythemia, which is an abnormal increase in the amount of red blood cells in the human body. The FDA required drug makers to add stronger warnings to the labels. The new warnings were to include information about the increased risk of blood clot issues.
The Time to Act is Now
If you or a loved one has been injured by using AndroGel, you may be entitled to financial compensation for your losses. You need experienced attorneys on your side.
Things that juries – and pharmaceutical companies – might consider when dealing with an AndroGel case include:
- The degree and duration of your testosterone-caused injuries;
- Any pain and mental suffering you experienced in the past and will likely experience in the future;
- The impact your injuries had on your physical and mental health and general well-being;
- Past or future medical expenses related to your injuries;
- Lost wages or lost earning capacity caused by your injuries;
- If the drug caused a wrongful death, any losses experienced by your family, such as loss of love, affection and companionship (often referred to as loss of consortium).
Our experienced attorneys are able to navigate the sometimes complex issues found in testosterone replacement therapy cases. We are dedicated to helping you through every step of the process and to getting you the justice you deserve. We represent people who have been prescribed and who have taken AndroGel and experienced DVT, PE, heart attacks, or strokes while on testosterone replacement therapy or within thirty days after.