October 2015 Update: Estey Bomberger attorneys are reviewing potential defective drug lawsuits for men who have suffered heart attack, stroke, blood clot or other serious problems while taking AndroGel testosterone gel. We are also reviewing potential cases for children who have suffered unwanted side effects from coming into secondary exposure of AndroGel. For more information or to stay up to date on the latest news and updates, contact us today.
Testosterone therapy was once a niche treatment for a relatively small number of people suffering from hormone deficiency. Now, in large part due to heavy direct-to-consumer marketing as a lifestyle product, many men are receiving testosterone gel therapy such as the blockbuster drug AndroGel without any real medical need. Many of the AndroGel ads used the “It was a Number” slogan to suggest that a blood test could simply diagnose Low T. However, decreased testosterone levels are a natural part of aging, gradually and normally falling about 1% per year after the age of 30.
It’s easy to see why pharmaceutical companies are aggressively marketing Low-T treatments. There is an appetite among men for feeling young. Insurance companies are willing to cover most of the cost of the high-priced treatments, which sell for more than $500/month retail. There are two problems with AndroGel and other Low-T treatments: (1) it is not known if they really work; and (2) it is not known how dangerous they may be. It is also unknown whether testosterone should be replaced in older men, and if it safely delays normal symptoms of aging, like decreased libido and decreased muscle mass.
So far, three studies have raised concerns about heart problems from Androgel:
2009 National Insitutes of Health Study – TOM Trial
The NIH, one of the world’s foremost medical research centers, funded a study involving 200 older men with a high prevalence of heath disease. The treatment phase of the trial was stopped early after 23 of the 106 men who had received testosterone experienced adverse cardiovascular-related events. This trial is referred to as the TOM (Testosterone in Older Men) trial.
JAMA Study – November 2013
The Journal of American Medicine (JAMA) published a study that found that men over age 60 had a 29% higher rate of heart attacks, strokes and death when they were given AndroGel or another testosterone replacement therapy.
PLOS One Study – January 2014
The PLOS One study found that testosterone treatments double the risk of heart attacks among men over age 65 and nearly triple the risk for younger men with a history of preexisting heart disease.
As a result of the PLOS and JAMA studies, on January 31, 2014 the FDA announced that it was investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.
AndroGel Frequently Asked Questions
What is AndroGel?
AndroGel is a prescription medication approved to treat low testosterone levels (low T).
Who makes AndroGel?
Androgel is manufactured by Illinois-based AbbVie, Inc., a spin-off of Abbott Laboratories. AbbVie also makes the blockbuster arthritis drug Humira.
When was AndroGel FDA-approved?
AndroGel 1% was originally FDA approved on February 28, 2000. AndroGel 1.62% was FDA approved on September 7, 2012. According to the New York Times, AbbVie spent $80 million advertising AndroGel in 2012, and the drug generated more than $1.4 billion in 2013.
What is AndroGel approved to treat?
The FDA approved Androgel “for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts.” However, the FDA is ambiguous as to what constitutes a very low amount.
Does AndroGel have a Black Box Warning?
Yes. Cases of secondary exposure to testosterone have been reported in children. In September 2009, the FDA placed a black blox warning about the risks of testosterone exposure to children. At least 20 children have been exposed to testosterone through contact with an adult and have reported adverse events including inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, aggressive behavior and increased libido.
If you have suffered side effects from AndroGel or any other prescription testosterone product, contact Estey Bomberger to discuss your potential case.