AndroGel: What You Need to Know About the History of Testosterone Therapy

Our Drug Safety Legal Team believes that patient undergoing low-t therapy have a right to know all the risks associated with testosterone treatment.

Testosterone is responsible for male sexual drive and masculine characteristics like facial hair, large muscles, and low body fat. As men age, testosterone production declines, and many men start to gain weight and lose muscle mass. Other signs of low testosterone include decreased sex drive, hair loss, irritability, mood swings and lack of energy. Some doctors call the onset of these symptoms “Andropause”.

Andro is the Greek word for man. The same root word is in AndroGel, a hormone gel used to treat low testosterone. The product is marketed by drug maker AbbVie.

AndroGel 1% has been used for hormone replacement therapy since 2000 when the drug was approved for use in men with testicular damage from injury, chemotherapy, or other trauma. By 2004, AndoGel was used off-label to counteract the symptoms of Andropause. AndroGel 1.62% was approved in 2011.

AndroGel is just one of several testosterone-containing drugs used in testosterone replacement therapy. These drugs replenish the body’s testosterone and reverse the effects of andropause. These drugs are very effective, but they are also associated with serious side-effects.

In September 2009, the U.S. Food and Drug Administration (FDA) ordered AbbVie to add a black box warning to the label of AndroGel, the source says.  The new label warned that children who were exposed to testosterone gels may develop enlarged genitals, pubic hair, increased libido, and aggressive behavior.

Drug safety advocates are now petitioning for a second black box warning.

This request comes after several studies that linked the use of testosterone products to an increased risk of heart attack, especially in men over age 65 and men with existing heart conditions. The FDA is currently reviewing this research. Meanwhile, millions of men are still using AndroGel and other testosterone products.

Our Drug Safety Legal Team believes that patient undergoing low-t therapy have a right to know all the risks associated with testosterone treatment. If you suffered a heart attack, stroke or other serious side effect while on testosterone therapy, you may be eligible to take part in a testosterone class action lawsuit against the drug manufacturer.  To learn more, please call the AndroGel injury hotline.