Testosterone injections, patches, and gels like AndroGel are promoted for men with low testosterone, or “Low T.” Unfortunately, new studies have found evidence that older men on testosterone could be more likely to suffer a deadly cardiovascular event.
UPDATE: $3 Million Awarded in AndroGel Retrial
March 2018 — A man who had a heart attack after using AndroGel testosterone gel has been awarded $3 million by a jury in Illinois. Click here to read more.
Testosterone is a male hormone (or “androgen”). It is made in the testicles, regulated in the brain, and influences male sexual characteristics like body hair, muscle tone, and sperm production. Testosterone therapy is only approved to treat hypogonadism, a rare condition due to problems in the brain or testicles that causes little or no testosterone production.
What is the problem?
After age 40, testosterone levels normally decrease by about 1-2% per year. Most older men with low testosterone do not need treatment. Drug-makers are accused of “disease mongering” and “illness inflation” — taking common everyday conditions and turning them into medical disorders to create a lucrative market for prescription drugs.
Testosterone is now widely promoted for common, non-specific, age-related symptoms like depressed mood, low libido, fatigue, sagging muscles, increased body fat, and more. However, a review of 150 studies has found no evidence that it actually works.
The number of prescriptions for testosterone therapy has jumped five-fold to 5.3 million in 2011. Only half of prescriptions were written for men with hypogonadism, and one-quarter of patients never even had a blood test to check testosterone levels.
In addition to the risk of side effects, testosterone therapy is a big commitment. The body stops making its own testosterone in response to supplements, which makes it extremely hard to quit.
Testosterone Therapy Products
- Androgel (AbbVie Inc.) – Topical gel applied to skin
- Androderm (Actavis) – Patch
- Axiron (Lilly USA, LLC) – Underarm liquid/cream
- Aveed (Endo Pharmaceuticals) – Intramuscular injection of testosterone and castor oil
- Bio-T-Gel (Teva Pharmaceuticals) – Topical gel applied to skin
- Delatestryl (Endo Pharmaceuticals) – Injection
- Depo-Testosterone (Unigen Life Sciences) – Injection
- Fortesta (Endo Pharmaceuticlas) – Topical gel applied to skin
- Natesto (Trimel Pharmaceuticals) – Nasal spray
- Striant (Auxilium Pharmaceuticals) – Buccal tablet absorbed through gums
- Testim (Auxilum Pharmaceuticals) – Topical gel applied to skin
- Testopel (Auxilium Pharmaceuticals) – Subcutaneous pellet
- Vogelxo (Upsher-Smith Laboratories) – Testosterone gel
Testosterone Heart Attack Risk Double for Men Over 65
Men over 65 years old who use testosterone therapy are twice as likely to have a heart attack, and men under 65 with a previous diagnosis of heart disease are three times as likely to have a heart attack if they take testosterone supplements. These conclusions, published in the journal PLoS One in January 2014, were based on data from 56,000 older and middle-aged American men from 2008 to 2010.
Testosterone Increases Heart Attack Risk by 30%
In November 2013, the Journal of the American Medical Association (JAMA) published a study linking testosterone therapy to a 30% increased risk of heart attack, stroke, and death among older men (average age 60). At three years, 25.7% of patients on testosterone therapy had a cardiovascular event. In 2014, drug-makers sued JAMA for publishing the study.
Highest Risk in First 6 Months of Treatment
Testosterone therapy boosts the risk of Venous Thromboembolism (VTE) by 63% during the first 6 months of treatment, according to a study of over 2.2 million men in the United Kingdom. The risk dropped off sharply after 6 months. While other studies have found no increased risk, researchers said these studies were flawed because they looked at the overall risk rather than focusing on the initial risk.
Cardiovascular Side Effects Linked to Testosterone
- Heart attack
- Blood clots
- Pulmonary embolism
- Deep Vein Thrombosis (DVT)
- Venous Thromboembolism (VTE)
FDA Safety Warnings
- January 31, 2014 — Safety Communication — FDA will investigate studies linking testosterone therapy to heart attacks, stroke, and death. The FDA has also reiterated that testosterone therapy is only approved for men with hypogonadism. Read more.
- June 20, 2014 — Safety Communication — FDA requires drug-makers to add warnings about the risk of venous blood clot complications, including pulmonary embolism (PE), deep vein thrombosis (DVT), and venous thromboembolism (VTE). Read more.
- March 4, 2015 — Safety Communication — FDA asks drug-makers to stop marketing testosterone for the treatment of age-related “Low T,” add warnings about heart attacks and strokes, and start studying the long-term risks. Read more.
Over 6,000 Testosterone Lawsuits
On June 6, 2014, federal judges centralized dozens of lawsuits involving testosterone replacement products into one federal court. The Multi-District Litigation (MDL No. 2545) will be located in the U.S. District Court for the Northern District of Illinois, overseen by Judge Matthew F. Kennelly.
As of April 2016, over 5,250 lawsuits had been filed by men who suffered cardiovascular events after using testosterone replacement products like Androgel. Click here to read more.
1st Trial Set for July 2017
In August 2016, Judge Kennelly set the first “bellwether” trial date for July 2017 and picked a case involving a man from Tennessee who had a heart attack after taking AndroGel. Click here to read more.
Risks vs. Benefits Unclear, Experts Urge Caution
In September 2014, an advisory panel to the FDA met to discuss the use of testosterone for age-related hypogonadism or “Low T.” They voted in favor of restricting the labels on testosterone treatment to clarify that testosterone is only for men who with hypogonadism. The FDA cautioned that the risks and benefits of testosterone therapy remain unclear.
In the meantime, regulatory agencies in Europe and Canada are warning about a “growing body of evidence” linking testosterone and heart problems. Consumer advocates are also demanding that the FDA add a boxed warning about cardiovascular risks, calling inaction “reckless.”
- April 2016 — Study finds that mice who are given testosterone have more calcification (bone-like calcium deposits) in their arteries, which is a major risk-factor for cardiovascular disease.
- August 2015 — Study finds that testosterone therapy does not appear to cause atherosclerosis, a major risk-factor for cardiovascular events, but it also does not seem to improve sexual health or overall quality of life.
- May 2015 — Study suggests that injections of testosterone (such as Depo-Tetsosterone) may spike a man’s risk of heart attack, stroke, and death compared to topical gel products like AndroGel, which are absorbed slowly through the skin.
- January 2015 — Study links first-time use of testosterone with a 41% increased risk of heart attack compared to non-users, and even higher risks for men with coronary artery disease.
- July 2014 — Study finds no link between testosterone and heart attacks after evaluating data on older men who received intramuscular injections of testosterone.
- October 2014 — Study in rodents finds a higher risk of prostate cancer when they were given testosterone replacement therapy.
- April 2014 — Experts are calling for new studies to investigate the safety risks of testosterone replacement therapy.