Testosterone 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 an 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. Call a testosterone lawyer at our firm to learn how you might be eligible for a lawsuit for any adverse effects from these drugs.
Information About 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.
• 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.
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|
Androderm is a testosterone replacement supplement that is produced and distributed by Actavis PLC, an international pharmaceutical company that operates in many different areas of the world. The drug company earned total product sales of $1.4 billion dollars in 2012 and is traded on the New York Stock Exchange as ACT. Actavis PLC manufacturers numerous prescription drugs as well as generic medications.
It is distributed as a patch that is applied to the skin. The patch contains a reservoir of testosterone that is absorbed into the body through the skin. This is advertised as a safe an effective way to deliver testosterone replacement therapy, however many studies refute these claims.
Axiron is a testosterone supplement made and distributed by Lilly USA, LLC, an international pharmaceutical company with operations all over the world. The drug is a topical solution that is applied to the skin which allows testosterone to be slowly absorbed by the body. This is advertised as both a safe and effective way to apply testosterone replacement therapy.
The manufacturers claim that their product poses no threat to other people coming into contact with the substance from a patient who has applied the gel to their skin.
Bio-T-Gel is a testosterone drug produced and distributed by Teva Pharmaceuticals, an international pharmaceutical company. In 2012, the company recorded $145 million alone for their “other specialty” drugs, which includes Bio-T-Gel. In addition to this testosterone supplement, Teva Pharmaceuticals also manufacture numerous prescription drugs and generic medications that are sold all over the world.
It is a gel substance that contains a reservoir of testosterone. The gel is applied topically to the skin, and testosterone is slowly absorbed by the body. Teva Pharmaceuticals maintains that this is a safe and effective way to administer testosterone replacement therapy. Additionally, the company also claims that the gel protects other people from accidentally coming into contact with testosterone during normal daily activities with patients using the drug.
Delatestryl is a testosterone drug manufactured and distributed by Endo Pharmaceuticals, an international pharmaceutical company. The company has a total of $30.5 million in sales in 2012 and trades on the NASDAQ American stock exchange as ENDP. In addition to Delatestryl, Endo Pharmaceuticals also produces numerous prescription drugs and generic medications.
It can be applied via injection or through a topical gel that is applied directly to the skin. The gel contains a reservoir of testosterone that is slowly absorbed through the skin after it is applied. Both the injection and the topical gel solution are promoted as a safe and effective way to administer testosterone replacement therapy. Endo Pharmaceuticals maintains that the Delatestryl gel protects against individuals accidentally coming into contact with the substance during daily activities with a patient using the drug.
The Depo-Testosterone drug is produced and distributed by Unigen Life Sciences, an international pharmaceutical company.
In addition to the supplement, the company also manufactures numerous prescription drugs and generic medications.
It is administered via injection, or through the skin as a topical solution. Both methods are advertised as safe and effective ways to apply testosterone replacement therapy. The manufacturers claim that their product poses no threat to other people coming into contact with the substance from a patient who has applied the gel to their skin.
Claims are being filed by men, their families, and their attorneys alleging that the risks of the testosterone drug were not properly disclosed by Unigen Life Sciences to consumers.
Fortesta is a testosterone supplement that is manufactured and distributed by Endo Pharmaceuticals, an international pharmaceutical company.
In addition to Fortesta, Endo Pharmaceuticals also produces the testosterone drug Delatestryl, along with many other prescription drugs and generic medications. The company reported total product sales of $30.5 million in 2012 and trades on the NASDAQ American stock exchange as ENDP.
It is applied to the skin as a topical gel. The substance contains a reservoir of testosterone that is slowly absorbed by the body once it is applied.
The drug is marketed as a safe and effective way to administer testosterone replacement therapy. Additionally, Endo Pharmaceuticals claims that the gel protects other people from accidentally coming into contact with the drug during normal daily activities with a patient who has it applied to their skin.
Striant is a testosterone drug produced and distributed by Auxilium Pharmaceuticals, Inc., an international pharmaceutical company.
The company reported total sales of over $230 million in 2012 and trades as AUXL on the NASDAQ American stock exchange. In addition to Striant, Auxilium Pharmaceuticals also manufactures numerous prescription drugs and generic medications.
It is administered in the form of an oral tablet, which contains a reservoir of testosterone that is absorbed into the bloodstream through the patient’s gums. This is advertised as a safe and effective way to apply testosterone replacement therapy. Recent studies refute these claims that the drug is safe, and many lawsuits are being filed on behalf of men and their families alleging the risks of using the testosterone drug were not properly disclosed by Auxilium Pharmaceuticals to consumers.
Testim is a testosterone supplement manufactured and distributed by Auxilium Pharmaceuticals, Inc., an international pharmaceutical company. In 2012, the company reported annual sales of $230 million. In addition to Testim, Auxilium Pharmaceuticals also produces Striant, another testosterone replacement therapy drug, as well as many other prescription drugs and generic medications.
It is a gel substance that is applied topically to the skin. The gel contains a reservoir of testosterone that is absorbed slowly through the skin and into the body. This is advertised as a safe and effective way to administer testosterone replacement therapy. Additionally, Auxilium maintains that the drug poses no threat to other individuals coming into contact with the gel during daily activities with a patient who has applied the supplement to their skin.
Testopel is a testosterone drug produced and distributed by Auxilium Pharmaceuticals, an international pharmaceutical company. In addition to Testopel, the company also produces the testosterone supplements Testim and Striant, as well as many other prescription drugs and generic medications. Auxilium Pharmaceuticals recorded total sales of over $230 million in 2012 and trades on the NASDAQ American stock exchange as AUXL.
It is manufactured in the form of a pellet, which is implanted by a health care provider underneath the patient’s skin in a fatty area. It is here that the reservoir of testosterone inside the pellet can best be absorbed into the bloodstream. Auxilium contests that this is a safe and effective way to administer testosterone replacement therapy to patients.
Testosterone Drug Side Effects & Complications
Medical studies have proven the link between testosterone replacement therapy and increased risk of heart attacks. Other side-effects of the drug includes non-fatal myocardial infarction, strokes, blood clots, enlarged breasts, and mood swings. As a result of these conditions, death can occur. Any side effects a person experiences from testosterone treatment should document them and discuss them with their lawyer.
Recent medical studies have demonstrated that testosterone drugs can cause heart attacks and non-fatal cardiac arrhythmia. These studies have prompted the FDA to investigate this serious complication even further. Several cases for cardiac death during and shortly after testosterone drug use are also being investigated. Additional research is expecting to confirm this serious complication.
Strokes (cerebral vascular accidents or “CVA”) are also a serious side-effect of testosterone supplements. These include ischemic stroke, embolic stroke, and hemorrhagic stroke. These conditions can lead to significant disability and even death.
Testosterone supplements can increase the risk of blood clot development. Blood clots can be life-threatening if blood flow to vital organs is obstructed. Other conditions, such as deep vein thrombosis (DVT) can result from the formation of blood clots.
Deep Vein Thrombosis
Deep Vein Thrombosis (DVT) is one of the serious side effects of continued use of testosterone drugs. Deep vein thrombosis occurs when blood clots form in the arms, legs, or pelvic region and cause the veins to be blocked. DVTs are life-threatening and can cause death if not timely diagnosed and treated.
A pulmonary embolism (PE) can occur after using testosterone. The drug causes changes in the number of red blood cells which causes the blood to thicken and clot. These blockages prevent the flow of oxygen to the heart and lungs. If untreated, a pulmonary embolism can cause death.
Blocked arteries can be caused by use of testosterone. The drug can cause the blood to thicken and block arteries throughout the body. This can cause significant harm. Many patients are forced to undergo surgery to repair arteries that have been damaged by these dangerous drugs.
Many of the serious health complications from testosterone can cause death. These include heart attack, stroke, pulmonary embolism and deep vein thrombosis. Wrongful death lawsuits are being filed seeking compensation for family members who lost a loved one due to the use of this drug.
Other Side Effects
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
A lawyer can discuss how your reactions to a testosterone treatment can impact your claim.
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. To learn more, speak with a knowledgeable testosterone lawyer.
What are the Criteria for Filing a Testosterone Lawsuit?
Testosterone Replacement Therapy (TRT) products for men have been linked to an increased risk of death, heart attack and stroke.
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 with thet help of an attorney:
- 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.
What is a Blood Clot?
A blood clot is a mass of blood that changes from a liquid state to a more solid state. In certain situations, such as when you injure or cut yourself, blood clotting is beneficial and can prevent you from losing too much blood. However, when a blood clot forms inside of your veins it won’t necessarily dissolve on its own. This can become very dangerous and even potentially life-threatening.
Reach Out to a Testosterone Attorney for Assistance
Testosterone drug lawsuits are filed against the drug producers by skilled and dedicated attorneys. Lawsuit allegations include that these companies:
- Failed to warn the public of the risks of taking testosterone drugs
- Failed to properly test testosterone drugs for the dangerous side-effects
- Withheld research data from the public about testosterone drug dangers
- Sold testosterone drugs even though they knew it could be dangerous
- Manufactured and sold an unsafe product
Our testosterone lawyers can help you demand full and fair compensation if you have been harmed by these therapies. To schedule a free consultation, call our legal team today.