The U.S. Food & Drug Administration (FDA) has warned that the popular testosterone supplement AndroGel may cause certain users to suffer a deep vein thrombosis (DVT). This side effect occurs when blood clots develop in a person’s deep veins, most often in the arms or legs. DVTs are dangerous because they increase the risk of a life-threatening pulmonary embolism (blood clot trapped in the lungs).
What is a Deep Vein Thrombosis?
DVTs occurs when a blood clot develops in the deep veins of the arms, legs or pelvis. This can cause blood cells to block the vein or the clot breaking off and traveling to an artery. This poses a significant risk since the blockage of arteries can restrict blood flow to the heart, brain or lungs. As a result, a patient with a deep vein thrombosis can easily suffer a heart attack, stroke, pulmonary embolism or death.
FDA Warning: AndroGel Use May Increase DVT Risk
In June 2014, the FDA issued a Drug Safety Communication stating that all prescription testosterone boosters will have their warning labels changed to include verbiage about the risk of deep vein thrombosis. Prior to this communication, only testosterone gel products carried information about the potential for DVT.
“FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products,” the warning states. “Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.”
Symptoms of Deep Vein Thrombosis
Deep vein thrombosis symptoms only occur in about 50% of patients who have the condition. When they are present, symptoms may include:
- Swelling in the foot, ankle or leg
- Leg cramping
- Foot / ankle pain
- Part of the skin that feels warmer than surrounding skin
- Skin over the affected area turning red or blue
- Some patients may not realize they’ve suffered a deep vein thrombosis until they’ve undergone emergency treatment for pulmonary embolism, a potentially fatal complication of DVT in which an artery in the lung gets obstructed.
How Can Testosterone Cause Blood Clots?
Prescription testosterone boosters including AndroGel may increase the risk of blood clots, heart attack, stroke and death, a recent Veterans Affairs study suggests. According to the study, testosterone users were 30% more likely to suffer a heart attack, stroke or to die during a 3 year period compared to men who did not take the supplements. Test subjects were in their early 60s on average, and most had other pre-existing health issues including high blood pressure and/or cholesterol and type 2 diabetes.
The research doesn’t prove conclusively that testosterone caused the complications, but it strengthens an earlier study in older men and should prompt doctors to discuss the risks associated with TRT, said study author Dr. Michael Ho, a cardiologist at Veterans Affairs in Denver.
The study, which was published in the Journal of the American Medical Association (JAMA) looked at health data on 8,700 U.S. veterans with low testosterone levels. All had undergone heart imaging exams and many had risk factors for heart problems, including blocked or restricted arteries. Risks associated with testosterone use were similar in men with and without prior heart issues.
More than one-quarter of testosterone users suffered complications within 3 years of the heart test, compared with 20% of non-users. It’s not clear how testosterone might increase heart risks, but scientists suggest that testosterone could make blood platelets stick together, which could promote the development of blood clots.
“There is only anecdotal evidence that testosterone is safe for these men,” said editorial author Dr. Anne Cappola, a hormone expert at University of Pennsylvania. “In light of the high volume of prescriptions and aggressive marketing by testosterone manufacturers, prescribers and patients should be wary.”
Who is at Risk?
Deep vein thrombosis occurs most often in individuals who are over the age of 60. Conditions that change how blood moves through the veins can increase the risk of DVT. These may include:
- Injuries that cause damage to the veins
- Being overweight
- Having a family history of deep vein thrombosis
- Having a catheter implanted in a vein
- Smoking cigarettes
- Remaining seated for a long time during car or plane rides
- Taking AndroGel or other testosterone supplement
Can I File an AndroGel Deep Vein Thrombosis Lawsuit?
Only a qualified attorney can determine whether you are eligible to file an AndroGel Lawsuit, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving pharmaceuticals allege that a drug was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain side effect. In the case of AndroGel, our attorneys suspect that patients may be able to take legal action in light of claims that manufacturers failed to adequately warn doctors and patients about the risk of deep vein thrombosis.
Do I have an AndroGel Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in AndroGel Lawsuits. We are handling individual litigation nationwide and currently accepting new AndroGel Deep Vein Thrombosis cases in all 50 states.
If you or a loved one suffered a deep vein thrombosis after taking AndroGel, you should contact our law firm immediately. You may be entitled to compensation by filing an AndroGel Deep Vein Thrombosis Suit and we can help.