Androgel is a testosterone product produced and distributed by AbbVie, Inc., an international pharmaceutical company. The company had total product sales of $1.52 billion dollars in 2012 and trades as ABBV on the New York Stock Exchange. AbbVie, Inc. is known to manufacture numerous prescription drugs and generic medications.
The gel contains a reservoir of testosterone and is applied topically to the skin. The drug is then delivered through the skin, in what is advertised as a safe and effective way to increase men’s natural testosterone levels. The manufacturers also claim that their formula protects other people from accidentally coming into contact with the drug through normal daily activities.
However, if you were harmed after using this product, an Androgel lawyer can help you file a claim to pursue compensation. Our attorneys have years of experience handling dangerous drug claims.
Reported Complications with Androgel
Researchers found men who used testosterone therapy–including Androgel–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.
Some reported complications with Androgel include:
- Pulmonary embolism
- Deep vein thrombosis
- Blood clots
Heart Attacks and Strokes
Testosterone treatment of older men was associated with a significant increase of coronary artery plaque, a waxy substance that can build up, harden and reduce the flow of oxygen to the heart. The results of a study done reached this conclusion and were published in February 2017 in the Journal of the American Medical Association.
On March 3, 2015, the FDA announced that it was requiring all manufacturers of testosterone medications to add warnings about an increased risk of heart attacks and strokes.
Stroke is most likely found in people with the following characteristics:
- Male, 60+ years of age
- Has used the drug for 2-5 years
- Low level of blood testosterone
The U.S. Food and Drug Administration updated the product labels as of January 2014. The revised labels clarify the approved uses of these medications and include information about the adverse effects the drug causes; specifically strokes and heart attacks.
JAMA Reports & FDA Findings on Androgel
The Journal of the American Medical Association found in its 2013 report that testosterone treatments may increase the serious risk of heart attacks, blood clots, strokes, and even death in men. The various drugs are advertised as a solution for men who cannot produce enough testosterone and suffer from reduced sexual functions, energy, and muscle mass. The study looked at over 8,000 men who were diagnosed with low testosterone levels (or Low-T) and treated with testosterone therapy drugs. A second study in 2014 found that Low-T treatments double the risk of cardiac arrest in young men with a preexisting condition and in men over the age of 65.
In light of the increasing usage of testosterone therapy drugs and the men suffering from adverse side effects, the FDA conducted an investigation into the drugs’ labeling. Earlier this fall, an FDA advisory panel strongly recommended that testosterone therapy drugs need to be updated so as to limit who may receive a prescription. The panel recommended the labels specifically limit the use of testosterone therapy for health issues that can be explained by aging, such as decreased sexual functions or energy. Stricter labels will reduce the number of patients receiving the treatment and limit the insurance coverage. As the JAMA study noted, Low-T treatment is a booming market as there were over 5.3 million prescriptions and the market reached $1.6 billion in 2011 alone. The panel specifically called out AbbVie’s Androgel as an example of easy-to-use and easy-to-get testosterone drugs.
Contact an Experienced Androgel Attorney Today
People who have experienced any of these symptoms after using this drug should contact an Androgel lawyer about the possibility of filing a lawsuit.