What is AndroGel?
AndroGel contains 1.62% testosterone, which is absorbed through the skin after application. The drug works by replacing or supplementing the testosterone that is naturally made in the body. AndroGel is made by AbbVie, and was approved by the U.S. Food & Drug Administration (FDA) in February 2000.
What’s the Problem?
AndroGel and other similar testosterone replacement therapy (TRT) supplements have recently been linked to serious side effects including heart attack, stroke, blood clots, brain damage and more. Lawsuits are being filed against AbbVie for failing to adequately warn the public and medical community of these risks on AndroGel’s labeling and advertising materials.
AndroGel Side Effects
Serious side effects of AndroGel may include:
- Heart attack
- Pulmonary embolism (blood clot trapped in the lungs)
- Deep vein thrombosis (blood clot in the legs)
- Venous thromboembolism (combination of pulmonary embolism and deep vein thrombosis)
- Arrhythmia (irregular heartbeat)
- Transient ischemic attacks (‘mini-strokes’)
- Brain damage
- Prostate cancer
- Larger red blood cells
- Reduced sperm count
- Sleep apnea
- High cholesterol
- And more
Study Highlights Risk of Heart Attack with Testosterone Supplements
Using testosterone boosters like AndroGel doubles the risk of heart attack among men over the age of 65, and nearly triples the risk in younger men with a history of heart disease, according to a January 2014 study published in PLOS ONE. The study also addressed whether these men were at a greater risk for cardiac problems due to an increase in libido caused by higher testosterone levels.
Francisco Lopez-Jimenez, a cardiologist at the Mayo Clinic in Minnesota who was not involved in the study, describes the heart attack risk posed by AndroGel as significant.
“That’s equivalent to smoking one or two packs of cigarettes a day, or having sky-high cholesterol,” Lopez-Jimenez said.
FDA Requires Heart Attack, Stroke Warning to be Added to Testosterone Labels
In March 2015, FDA required manufacturers of testosterone supplements to update their products’ labeling with a warning about an increased risk of heart attack, stroke and other severe cardiovascular side effects. The agency also cautioned that testosterone boosters should not be prescribed to men for the sole purpose of treating symptoms associated with the natural aging process. FDA has only approved testosterone replacement therapy as a treatment for men who have clinically low testosterone levels caused by disorders of the testicles, pituitary gland or hypogonadism.
“Black Box” Warnings
In September 2009, FDA required that AndroGel labels carry a “black box” warning (PDF) stating that children exposed to the product could experience changes in genital size, pubic hair or libido, and become unusually aggressive. Two years later, in March 2011, another warning (PDF) was issued stating that AndroGel users should wait at least five hours before showering or swimming after applying the product.
As of mid-2016, at least 5,000 testosterone lawsuits have been consolidated in a multidistrict litigation (MDL No. 4525) in the U.S. District Court Northern District of Illinois. The complaints allege that AndroGel and other similar products caused users to suffer heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other serious injuries. The first bellwether trials in the MDL are scheduled to begin in early 2017.
1935 – Introduced to treat hypogonadism
1935 – Isolated testosterone is synthesized and introduced to treat hypogonadism.
1953 – FDA approves Delatestryl
1953 – FDA approves Delatestryl to treat conditions associated with a deficiency or absence of testosterone.
February 2000 – Approved by the FDA
February 2000 – AndroGel approved by the FDA.
2000 – FDA issues warning
2000 – FDA warns AbbVie that claims suggesting AndroGel is indicated for men with “age-associated hypogonadism” or “andropause” are misleading.
2000 – Geriatrics doctor develops quiz
2000 – A geriatrics doctor at the St. Louis University School of Medicine develops a quiz designed to help men self-diagnose whether they need TRT.
2003 – Federal whistleblower allegations
2003 – Federal whistleblower lawsuit against AbbVie alleges that the company made millions by marketing AndroGel for unapproved purposes and paid kickbacks to doctors to prescribe the drug.
2006 – AndroGel sales
2006 – AndroGel sales reach $300 million.
2007 – Over 100 million doses prescribed
2007 – More than 100 million doses of testosterone are prescribed in the U.S.
September 2009 – FDA labeling requrement
September 2009 – FDA requires AndroGel labels to carry a “black box” warning stating that children exposed to the product could experience changes in genital size, pubic hair or libido, and become unusually aggressive.
March 2011 – AndroGel labels require second boxed warning
March 2011 – AndroGel labels required to carry a second boxed warning cautioning against swimming or bathing for at least five hours after applying the product.
2011 – Testosterone statistic
2011 – Nearly one in 25 men in their 60s are taking testosterone.
2011 – Lawsuit filed against AbbVie
2011 – Kansas resident Robert Cripe files a lawsuit against AbbVie after having a stroke he says was caused by AndroGel.
2012 – Advertising tops $100 million
2012 – Drugmakers spend more than $100 million advertising testosterone supplements; sales reach $2 billion.
2013 – JAMA study published
2013 – The Journal of the American Medical Association (JAMA) publishes a study suggesting that Low T is a “mass, uncontrolled experiment, which invites men to expose themselves to the harms of a treatment unlikely to fix problems which they may not really have.”
January 2014 – PLOS ONE study published
January 29, 2014 – Study published in PLOS ONE finds that testosterone supplements double the risk of heart attack among men over the age of 65, and nearly triple the risk in younger men with a history of heart disease.
2014 – FDA requires warning
2014 – FDA requires testosterone manufacturers to include a warning about health risks, including pulmonary embolism.
March 2015 – FDA issues Drug Safety Communication
March 3, 2015 – FDA issues a Drug Safety Communication stating that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.”
1999 – Big Pharma coins phrases
1999 – Big Pharma coins the phrases “Low T” and “Andropause” to persuade men that there is a new condition they need to be treated for; critics say this condition is simply the natural aging process.
2017 – Bellwether trials scheduled
2017 – The first bellwether trials of more than 5,000 testosterone lawsuits scheduled to begin.
- “MDL 2545: In re Testosterone Replacement Therapy Products Liability Litigation”. United States District Court Northern District of Illinois.
- “Testosterone Products: Drug Safety Communication – FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke”. U.S. Food & Drug Administration (FDA). March 3, 2015.
- “AndroGel Medication Guide”. AbbVie Inc. June 2014.
- “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men”. PLOS ONE. January 29, 2014.
- “AndroGel Prescribing Information”. U.S. Food & Drug Administration (FDA). September 2009.
- “AndroGel Drug Approval Package”. U.S. Food & Drug Administration (FDA). September 17, 2003.