Testosterone Lawsuits: Heart Attacks, Strokes, Blood Clots and Pulmonary Embolism
Commonly asked questions about testosterone supplement products:
- What is it?
- Why am I taking it?
- What are the serious side effects?
- What are the Criteria for Filing a Testosterone Lawsuit?
- Warnings and lawsuits status
- What are some types of it?
- Video information on lawsuits
- Can I file a lawsuit?
- Our no-fee promise on drug cases
- How do I start a drug claim?
What is Testosterone?
It is a hormone essential to the development of male growth and masculine characteristics. It’s essential for the growth and development of male sex organs and maintenance of secondary male characteristics, such as facial hair.
Testosterone products are widely used by men throughout the United States.
Testosterone products are FDA-approved only for use in men who lack or have low levels in conjunction with an associated medical condition. These supplements have been aggressively advertised by drug companies in the media for men who have “Low T,” or low testosterone, to combat part of the natural aging process.
The medicine is publicized to improve sex drive, increase energy, improve mood, and improve muscle and bone strength.
Testosterone drugs are sold as a gel, a transdermal patch, a topical solution, a tablet, and a under the skin pellet. Many men are on a Low T supplement for several years.
Testosterone products are FDA-approved for use in men who lack or have low levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce it for reasons such as genetic problems or chemotherapy.
Statistics about Testosterone
• Approximately 70 percent of men who receive prescriptions through retail pharmacies are between 40 and 64 years old.
• In the past five years, the use of replacement therapy has increased significantly, from 1.3 million patients in 2009 to 2.3 million patients in 2013 receiving a prescription for a testosterone product.
Why Am I Taking Testosterone?
Testosterone therapy is used to treat men suffering from deficiencies, which can negatively affect muscle mass, sex drive and energy levels.
The condition, known as hypogonadism, results in lower strength, reduced energy and diminished sexual function. However, research has suggested that many men taking gels, injections or other treatments may not have a medical need for the hormone replacement therapy, and may actually be exposing themselves to an increased risk of heart attack, stroke or death.
You may have been prescribed testosterone product(s) by a doctor due to failure of the testicles to produce it because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary, that control the production by the testicles.
None of the FDA-approved products are approved for use in men with low levels who lack an associated medical condition. It is estimated that a quarter of the men prescribed TRT had never had their testosterone levels checked.
What are the Serious Side Effects of Testosterone?
Recent medical and scientific studies have shown that there are several serious health risks to men caused by these drugs.
Recent studies have identified a link between replacement therapy and increased risk of heart attacks.
Other side effects of the drugs include non-fatal myocardial infarction, strokes, blood clots, enlarged breasts, and mood swings. As a result of these conditions, death can occur.
One drug, Androgel, warns on its label a number of side effects, including high blood pressure, blood clots in the legs, and “serious problems” for people who have heart, kidney or liver disease.
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
What are the Criteria for Filing a Testosterone Lawsuit?
Testosterone therapy, such as the prescription topical treatments Androgel, Testim and Axiron, are used to help boost testosterone levels in men who have a deficiency of the male hormone. Symptoms of low testosterone include decreased libido and low energy.
Researchers found men who used testosterone therapy were 30 percent more likely to have a heart attack, stroke, or die after three years of use.
A second study found that men had a significant increase in risk of heart attack and stroke in just the first 90 days of testosterone therapy use. Furthermore, men who started the study with clear, unobstructed coronary arteries were just as likely to have a heart attack, stroke or die as men who entered the study with established coronary artery disease.
The following criteria must be met for a patient to file a testosterone lawsuit:
- Must be male
- Must have used name-brand TRT only, no shots
- Must have had one of the following injuries:
- Heart attack
- Myocardial infarction
- Blood clot
- Sudden cardiac death
- Pulmonary embolism
- Deep vein thrombosis
- Cardiogenic embolism
- Blindness caused by blood clot to the eye
- Other injury caused by a blood clot
- If injury occurred while patient was taking TRT, must have been taking TRT for at least one month when the injury occurred
- If injury occurred after patient stopped taking TRT, must be no more than 30 days since discontinuation of TRT when injury occurred
Heart Attack Lawsuits
On January 31, 2014, the U.S. Food and Drug Administration announced it was investigating the risk of heart attack and other serious conditions from approved testosterone drugs.
The announcement was initiated by a Journal of the American Medical Association (JAMA) study, published on November 2013, that raised concerns over drugs and their possible link to heart attacks and other complications.
Researchers reported that men who used testosterone were 30 percent more likely to have a heart attack or stroke or die during a three-year period than men with low hormone levels who didn’t take the supplements.
The National Cancer Institute conducted a study of more than 55,000 men who had low T. The study found that some men using prescription testosterone therapies have an increased risk of suffering heart attacks and other cardiac problems. Men over the age of 65 had double the risk of heart attack in the first three months of low-T treatments.
Researchers from the Veteran Affairs Eastern Colorado Health Care System in Denver found the rate of cardiovascular events was 25.7 percent among men who took testosterone therapy drugs, compared to a rate of 19.9 percent among those who did not.
Out of 1,223 patients, researchers discovered that within a year and a half, 67 had died, 23 suffered heart attacks and 33 had strokes.
Blood Clot Lawsuits
In June 2014, the FDA determined that stronger warnings for the blood clot risks were needed, indicating that the medications may cause venous thromboembolism (VTE).
As a result, the FDA required 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 FDA’s statement came on the heels of the agency’s investigation of the possible risk of stroke, heart attack, and death in patients taking these products.
“We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014,” the FDA released in a written statement.
Testosterone Warnings and Lawsuits Status
Although there has been no recall or official warning by the FDA on TRTs, the FDA announced on January 31, 2014 that it would examine the safety of testosterone products applied via patch, gel, buccal system, or injection.
The manufacturers of two prescription topical gel products, AndroGel 1 percent and Testim 1 percent, were required to include a boxed warning on the products’ labels.
The FDA reportedly required this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).
In addition, five Androgel lawsuits were filed on Feb. 4, 2014 in Illinois federal court against the manufacturers AbbVie Inc., and Abbott Laboratories, Inc., claiming manufacturers concealed facts about serious side effects associated with the drug.
What are Some Types of Testosterone?
FDA-approved formulations include topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.
Pharmaceutical companies sell the drugs under these popular names:
|Axiron||Topical Solution||Eli Lilly|
|Delatestryl||Topical Solution, Injection||Indevus|
|Topical Solution, Injection||Pfizer|
TV Commercial About Testosterone Lawsuits
Can I File a Testosterone Drug Lawsuit?
Our dangerous drug attorneys can help if you or someone you care about was harmed by testosterone.
Lawsuits have been filed against the drug maker by both patients and their families seeking compensation for injuries caused by this dangerous drug. You may be entitled to a settlement.
We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it in all in writing for you. Our drug lawyers will help you file your lawsuit.
Our No-Fee Promise on Testosterone Drug Cases
You can afford to have our great team of lawyers on your side. When you choose us, it literally costs nothing to get started. We promise you in writing:
- No money to get started
- We pay all case costs and expenses
- No legal fees whatsoever unless you receive a settlement
- Phone calls are always free.
How Do I Start a Testosterone Drug Claim?
Our drug lawyers will help you file your lawsuit. To get started, you can:
- Submit the Free Case Review Box on this page, or
- Call (866) 280-3417 any time of day to tell us about your case.
We will listen to your story and answer your questions. If you have claim, we will start immediately.
WARNING: There are strict time deadlines for filing drug lawsuit claims.
Testosterone Side Effects, Recall Information & Settlements
Learn more about side effects.
Get information about recalls.
Find a testosterone therapy lawyer here.