Low-T products are widely used to treat men diagnosed with a deficiency or absence of natural testosterone associated with a medical condition called hypogonadism. However, a growing number of men are using testosterone replacement products like AndroGel and Androderm to combat the natural signs of aging, like low testosterone levels, decreased sex drive, loss of energy and fatigue. According to a study published in the Journal of the American Medical Association, by 2011, close to one in 25 men in their 60s was taking testosterone drugs, which doctors blame on the aggressive marketing by pharmaceutical companies like AbbVie. “The market for testosterone gels evolved because there is an appetite among men and because there is advertising,” says Dr. Joel Finkelstein, an associate professor at Harvard Medical School. “The problem is that no one has proved that it works, and we don’t know the risks.”
AndroGel is a topical testosterone gel manufactured by AbbVie, a pharmaceutical company that spun off of Abbott Laboratories in 2013, when Abbott split into two separate, publicly traded companies. AndroGel was originally developed by Solvay Pharmaceuticals, and when AbbVie acquired the company in 2010, it began pumping millions of dollars into the marketing of the testosterone gel. Soon after though, doctors started voicing concerns about the potential side effects of AndroGel among older users, after it was discovered that many men were being prescribed the low-T gel as a means of regaining their youth or boosting their energy levels and sex drive.
AndroGel is a synthetic testosterone mixed with alcohol into a topical gel that is designed to be applied to the skin once a day, and is absorbed by the skin for continuous 24-hour delivery into the body. In men with low-T, AndroGel can increase the total amount of testosterone circulating in the body to a normal range found in healthy men, which the medication guide says is between 298 and 1043 ng/dl. AndroGel is available in two strengths – 1 percent, which can be applied to the upper arms and shoulder, or on both sides of the abdomen, and 1.62 percent, which should only be applied to the upper arms and shoulders.
One of the most serious side effects potentially associated with AndroGel use is an increased risk of heart attacks, strokes, and other adverse cardiovascular events, and the testosterone gel carries a black-box warning for secondary exposure to women and children, indicating that they should avoid contact with unwashed application sites or the unwashed clothing of men using the testosterone gel. The makers of the AndroGel face a growing number of product liability lawsuits filed on behalf of users who believe they have been harmed by the low-T gel. Even still, AndroGel is the best-selling testosterone replacement product in the United States, and in 2012, the testosterone gel generated more than $1 billion in sales for AbbVie.
Androderm is a transdermal skin patch used to treat adult males who have low testosterone levels due to hypogonadism, but is commonly prescribed off-label to men with low-T associated with the natural aging process, even though it has never been approved for this use. Androderm was originally developed by Watson Pharmaceuticals, and was one of the first testosterone treatments approved by the FDA for use among men throughout the United States. Androderm was initially introduced by Watson in 1995, and was then re-introduced by Actavis in 2011, in a stronger concentration.
The once-daily Androderm testosterone patch is designed to deliver testosterone continuously for 24 hours following application of the patch to intact skin on the back, abdomen, upper arms or thighs. Androderm has a central drug delivery reservoir in the patch, which is surrounded by an adhesive area, and contains testosterone USP dissolved in an alcohol-based gel. There are two strengths of Androderm that deliver approximately 2 mg or 4 mg of testosterone per day, and the patch has been aggressively marketed by Actavis as safer than testosterone gel products, like AndroGel.
A growing number of studies have found a risk of serious and potentially life-threatening complications among men using testosterone therapy products like Androderm, and the use of Androderm has been linked to an increased risk of side effects like prostate cancer, blood clots, heart attacks, strokes and lower sperm count. Watson Pharmaceuticals and Actavis now face product liability lawsuits filed on behalf of men who claim that the pharmaceutical companies used deceptive marketing practices to downplay the risks associated with Androderm treatment.
Axiron is a newer testosterone treatment, introduced by Eli Lilly in 2010 to compete with the widely-used AndroGel testosterone gel developed and sold by AbbVie. Eli Lilly marketed Axiron as a superior alternative to other testosterone products, like AndroGel, long after the makers of low-T products knew or should have known about the potential for the medications to cause potentially life-threatening side effects in users. As a result of this alleged failure to warn, Eli Lilly’s Axiron testosterone cream sold well, and quickly earned the company more than $300 million in annual sales.
Axiron is a testosterone cream that is applied under the arm via deodorant, and is designed to elevate testosterone levels in men struggling with low-T, by delivering testosterone to the body through transdermal absorption. Men using Axiron are directed to pump the medication into the applicator cup, and then use the applicator to apply the testosterone cream to clean, dry skin under the armpits once daily in the morning. The testosterone underarm cream is designed to be used regularly in order to increase testosterone levels in men.
Although Axiron has been marketed as a safe and effective treatment for men with low-T, Axiron has been linked to an increased risk of heart attack, stroke, blood clot, sudden death and other devastating side effects. As a result of this alleged risk, men across the country are pursuing legal claims against Eli Lilly, accusing the drug maker of failing to provide adequate warnings about the potential for Axiron to cause serious complications in users.
Aveed is an intramuscular testosterone injection manufactured by Endo Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in March 2014, after the agency denied three previous applications for the low-T treatment. The consumer watchdog group Public Citizen urged the FDA to “delay its decision date on approving a new long-acting injectable testosterone product Aveed (testosterone undecanoate, Endo) now set for February 28, 2014, because its approval, absent the new black box warning, could cause further cardiovascular harm to patients for whom this new formulation is prescribed.”
Aveed is a 3-mL intramuscular injection containing testosterone and castor oil, a vegetable oil that is associated with such health benefits as treating skin infections, gastrointestinal problems, arthritis and constipation. Aveed injections are given at the beginning of therapy, and then at four weeks, ten weeks, and every ten weeks thereafter. Aveed is designed to be used in men with hypogonadism and accompanying issues, like missing testicles, genetic disorders, brain disorders or cancer, but is often prescribed off-label to men struggling with symptoms of low-T associated with the natural aging process, like diminished sex drive and low energy levels.
Serious concerns have been raised about the safety of Aveed recently, and the low-T injection carries a black-box warning due to the potential for the testosterone treatment to cause pulmonary oil microembolism (POME), a serious lung condition in which blood vessels become clogged by tiny droplets of oil. According to reports, POME can occur during or after an injection of Aveed, and this potential side effect is what delayed the initial approval of the low-T injection. Other potential side effects of Aveed include stroke, heart attack, blood clots, pulmonary embolism and death.
Bio-T-Gel was approved by the FDA in February 2012 for the treatment of hypogonadism in adult men, in conjunction with a medical condition like undescended testicles, brain disorders or chemotherapy side effects. The topical testosterone gel was developed by Illinois-based BioSante Pharmaceuticals and is sold by its Israel-based partner, Teva Pharmaceuticals. Bio-T-Gel is marketed as a safe and effective way for men to absorb testosterone, and is designed to protect other people from accidentally coming into physical contact with the gel during routine activities.
Bio-T-Gel is a prescription testosterone gel that is designed to be applied topically to the skin at the same time each day, either on the shoulders, upper arms or stomach area, so that the testosterone in the gel can be absorbed through the skin and into the bloodstream. Bio-T-Gel topical gel contains a reservoir of testosterone supplementation, which is designed to seep into the skin gradually during the course of the day. Unlike other testosterone gels that use natural ingredients to elevate testosterone levels, Bio-T-Gel contains real testosterone, and is meant for men who have less than 300 ng/dl of testosterone.
Topical testosterone products like Bio-T-Gel and AndroGel have been shown to be effective in elevating testosterone levels. However, research suggests that Bio-T-Gel may also thicken the blood, which can increase the number of red blood cells and increase blood pressure as well, and the use of Bio-T-Gel among men with low-T has been linked to an alleged increased risk of side effects like stroke, heart attack, blood clots, deep vein thrombosis, pulmonary embolism, and sudden death.
Delatestryl is a prescription testosterone injection manufactured by Indevus Pharmaceuticals, and commonly used to treat low testosterone levels associated with hypogonadism in aging men. Delatestryl has been on the market in the United States for more than 30 years, and in some cases, the testosterone injection is also used to stimulate puberty in males with clearly delayed puberty
Each mL of Delatestryl contains 200mg of testosterone enanthate (a derivative of the primary endogenous androgen testosterone) in sesame oil, along with 5mg of a preservative, and men undergoing Delatestryl therapy receive intramuscular injections of the low-T drug every two to four weeks. According to the Delatestryl prescribing information, the testosterone injection is designed to stimulate the production of red blood cells by enhancing the production of “erythropoietic stimulating factor.” However, a higher number of red blood cells can also result in thicker blood and higher blood pressure, which can cause serious complications in users.
Studies have shown that men who use Delatestryl and other testosterone replacement therapies may face an increased risk of devastating side effects, including heart attack, blood clots, deep vein thrombosis, stroke, pulmonary embolism and death. Unfortunately, Delatestryl treatment is considered a lifetime commitment, as the body begins to shut down its own testosterone production once testosterone supplements are introduced.
Depo-Testosterone is an injectable testosterone replacement therapy used to treat men diagnosed with low testosterone levels associated with hypogonadism. Depo-Testosterone is manufactured by Pharmacia & Upjohn Co., a subsidiary of pharmaceutical giant Pfizer, and was approved by the FDA in 1979. Despite the fact that Depo-Testosterone is one of the oldest testosterone treatments on the market in the United States, the low-T injection continues to make money for Pfizer and its Pharmacia & Upjohn Co. unit. Depo-Testosterone is specifically indicated for use among men with testicular failure that they were born with, or that occurred because of a disease.
Unlike AndroGel and Bio-T-Gel, Depo-Testosterone is not a topical gel applied to the skin; it is a liquid consisting of the active ingredient testosterone cypionate, and other ingredients, like cotton seed oil, benzyl benzoate and benzyl alcohol, and is designed to be injected into the muscle. Depo-Testosterone injections remain in the body for several days, and patients are instructed to inject a dose of the low-T drug every two to four weeks. Hormones then bind to receptors in the body, and roughly 90% of the testosterone is expelled from the body through urine and feces.
Estimates suggest that more than two million men use injectable hormone medications like Depo-Testosterone, which have been linked to an increased risk of cardiovascular side effects, like heart attack and stroke in users, as well as a risk of blood clots, deep vein thrombosis, pulmonary embolism, prostate cancer and death. Men who have suffered complications while using Depo-Testosterone accuse Pfizer of “disease mongering,” by overstating the benefits of the low-T drug and downplaying its risks.
Fortesta is a prescription testosterone medication approved by the FDA in December 2010, and currently manufactured by Endo Pharmaceuticals, a pharmaceutical company that had total product sales of $30.5 million in 2012. According to Endo’s website, Fortesta is a gel “that’s applied directly and discreetly onto the front and inner thighs” and “may be all that’s needed to help raise your T.” Prescribing information for Fortesta recommends a starting dose of 40mg, to be applied once daily in the morning for elevated testosterone levels.
Fortesta is a topical gel that contains synthetic testosterone, and is designed to treat low levels of naturally-occurring testosterone associated with hypogonadism. Men using Fortesta testosterone supplements are directed to apply the product directly to the skin so that the testosterone gel can be absorbed through the skin and into the bloodstream. Endo Pharmaceuticals claims that this method of application protects other people from accidentally coming into physical contact with the low-T gel during normal daily activities.
Studies have shown that testosterone supplements like Fortesta are prescribed to nearly 3% of all American men over the age of 40, for conditions ranging from hypogonadism to low-T levels associated with the natural aging process. Unfortunately, a growing body of research has linked Fortesta and other testosterone treatments to an increased risk of blood clots, heart attack, stroke, and other serious cardiovascular side effects. According to Fortesta lawsuits, the risks allegedly associated with the testosterone gel were not properly disclosed to the public by Endo Pharmaceuticals.
Natesto is a prescription testosterone product that comes in the form of a nasal spray, and was approved by the FDA in 2014, for the treatment of low-T associated with hypogonadism. Natesto was originally developed by Trimel BioPharma SRL, but the company was acquired in 2015 by Endo Pharmaceuticals, which manufactures other low-T treatments, including Aveed and Fortesta. Natesto was the first-ever nasal testosterone spray to enter the market in the United States, and was approved by the FDA in the midst of concerns about the safety of testosterone replacement therapy.
The testosterone nasal spray Natesto is designed to be administered via a metered-dose pump activator into the nostrils, with two spritzes (one in each nostril) three times per day, and each spritz of Natesto contains 5.5mg of testosterone, for a total daily dose of 33mg. Natesto is marketed as a superior alternative to topical testosterone gels like AndroGel, because the nasal spray is less likely to spread testosterone to other people through skin-to-skin contact. A possible downside of Natesto is that testosterone levels in the body may be significantly higher with intranasal low-T administration than with other routes.
Like other low-T treatments, Natesto has been linked to an increased risk of cardiovascular problems such as heart attack and stroke, due to the potential for testosterone to thicken the blood and elevate blood pressure. As a result of this risk, prescriptions for Natesto and other testosterone treatments are declining, as the number of product liability lawsuits brought against the makers of these low-T products continues to climb. Any Natesto lawsuits filed against Trimel BioPharma over side effects allegedly caused by the testosterone nasal spray were inherited by Endo Pharmaceuticals when it acquired the company.
Striant is a testosterone tablet developed by Auxilium Pharmaceuticals, and the tablet is designed to be absorbed through the gums in order to treat a deficiency or absence of testosterone associated with hypogonadism. Striant’s delivery system, known as the testosterone buccal system, was approved by the FDA in June 2003.
Striant is a buccal system for delivering testosterone to the body through mucous membranes in the mouth, and each buccal system contains 30mg of testosterone. Men using Striant are instructed to adhere the testosterone tablet to the gums or inner cheek, where the product slowly distributes a controlled amount of testosterone into the body over the course of 12 hours. Striant is meant to be inserted twice a day, once in the morning and once in the evening, for continuous delivery of testosterone, and is considered an innovation in the administration of testosterone, due to its low maintenance dispersal system.
Despite its novel method of delivering testosterone into the body, Striant, like other low-T products, has been linked to an alleged increased risk of serious side effects, including stroke, heart attack, blood clots, deep vein thrombosis and sudden death. In fact, recent studies have linked testosterone treatments to a two-fold increased risk of heart attack for men over the age of 65, and a 30% increased risk of stroke, heart attack and death. Says Francisco Lopez-Jimenez, a cardiologist at the Mayo Clinic, “That’s equivalent to smoking one to two packs of cigarettes a day, or having sky-high cholesterol.”
Testim is a prescription testosterone gel marketed by Auxilium Pharmaceuticals for the treatment of hypogonadism, or low testosterone levels resulting in symptoms like fatigue, sexual dysfunction and depressed mood. Testim was approved by the FDA in 2002, and has been marketed by Auxilium and its subsidiaries for years, after they acquired the companies that introduced Testopel testosterone pellets. According to reports, Testim generates more than $200 million in sales every year for Auxilium.
Like AndroGel, Testim is a topical testosterone gel product designed to be applied directly to the skin, so the testosterone can be absorbed through the skin and into the bloodstream. The medicated gel contains testosterone, a hormone found naturally in the body that helps the body produce sperm and develop male sexual characteristics, like body hair and a deep voice. When applied topically once a day, Testim can help the body reach normal testosterone levels, thereby increasing bone density and libido, improving energy levels and enhancing sexual function.
In spite of the possible benefits of Testim, research has shown that side effects of Testim and other testosterone treatments may increase the risk of severe and potentially life-threatening injuries in users, including heart attack, pulmonary embolism, stroke and sudden death. As a result, a growing number of men across the country are pursuing legal claims against the makers of testosterone products like Testim, accusing the companies of overstating the benefits of the treatments, while downplaying their risks.
Testopel is a testosterone pellet injection indicated for the treatment of low testosterone levels due to hypogonadism, and manufactured by Auxilium Pharmaceuticals, a drug maker that brought in more than $233 million in sales in 2012 alone. Testopel was approved by the FDA in 2008, and is designed to improve sex drive, build muscle and strengthen bones in middle-aged and older men struggling with low-T. Testopel is often used by men who don’t want to have to remember to apply a topical gel or cream, like AndroGel or Axiron, every day.
Testopel is a testosterone pellet that is inserted by a medical professional under the patient’s skin, in a fatty area, where it releases testosterone into the body for three to four months. Unlike testosterone gels and creams, which have to be applied daily, Testopel secretes testosterone into the bloodstream for up to four months. To date, Testopel is the only FDA-approved testosterone pellet injection on the market, and is marketed as a safer alternative to testosterone gels, which can rub off on women and children who come in physical contact with the products on the skin.
Being that Testopel is the only testosterone product of its kind, Auxilium Pharmaceuticals is facing product liability lawsuits specific to testosterone pellet injections for injuries among users. According to reports, Testopel may be linked to serious and potentially deadly side effects in men, including heart attack, stroke and pulmonary embolism.
Vogelxo is a testosterone gel manufactured by Upsher-Smith Laboratories, and indicated for the treatment of low testosterone associated with hypogonadism in males. Vogelxo was approved by the FDA in June 2014, despite nationwide concerns about the safety of testosterone replacement therapy, and in the midst of a safety investigation launched by federal regulators earlier that same year.
Like AndroGel, Vogelxo is a topical testosterone gel applied to the skin and absorbed directly into the bloodstream. Men using Vogelxo testosterone gel are instructed to apply the gel once a day to clean, intact skin on the shoulders and/or upper arms, and the medication provides continuous transdermal delivery of testosterone for 24 hours. Vogelxo is sold in tubes that contain 5g of translucent hydroalcoholic gel and 50mg of testosterone, an androgen. Vogelxo is also available in two-count cartons with 88g metered-dose pumps, with each pump delivering 12.5mg of testosterone.
Serious concerns have been raised about the safety of testosterone products like Vogelxo, due to the potential for the low-T drugs to put men at risk for side effects like heart attack, stroke, pulmonary embolism, blood clots and sudden death. As a result, men across the country are filing product liability lawsuits against the makers of testosterone products like Vogelxo, alleging that the drug companies failed to provide adequate warnings to the public about the risks associated with the medications.
In January 2014, the FDA issued a safety announcement notifying consumers and the medical community that the agency planned to investigate the alleged increased risk of heart attack, stroke and death among men using FDA-approved testosterone products like AndroGel and Testim. If you underwent testosterone replacement therapy, and you have since suffered a potentially life-threatening complication like heart attack, stroke, deep vein thrombosis, pulmonary embolism or blood clots, our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of consumers harmed by allegedly dangerous medications, and can help put you in touch with a qualified lawyer who has experience handling testosterone replacement therapy claims.