Androderm (testosterone patch) has become controversial in light of recent studies and FDA investigations into life-threatening heart risks. Several lawsuits accuse drug-makers of “disease mongering” testosterone products like Androderm to men who are losing testosterone as a natural part of aging. Unfortunately, recent studies indicate that Androderm may increase the risk of blood clots, heart attack, stroke, and death, especially in older men.
What is Androderm?
Androderm is a patch that delivers testosterone, a male hormone (or “androgen”), via transdermal absorption through the skin. It was developed by Actavis Inc. as a long-lasting treatment for low testosterone.
FDA Adds Heart Attack, Stroke Warnings to Testosterone Products
March 3, 2015 — In a Safety Communication, the FDA is asking manufacturers of testosterone replacement products to stop marketing them for the treatment of age-related “Low T,” add warnings about heart attacks and strokes, and start studying the long-term risks. Click here to read more.
1st FDA Safety Warning for Testosterone
January 31, 2014 — In a Drug Safety Communication, the U.S. Food and Drug Administration (FDA) is warning about potentially life-threatening side effects of Androderm and other testosterone replacement products. They are concerned about several studies indicating an increased risk of heart attack, stroke, and death.
Studies of Testosterone Side Effects
The FDA announcement came just days after PLoS One published a study linking testosterone therapy and a 2X increased risk of heart attack for men over 65. Just three months earlier, another study found that testosterone could increase the risk of heart attack, stroke, or death by 30%.
When USA Today interviewed a cardiologist from the Mayo Clinic on the studies, he said:
“That’s the equivalent to smoking one or two packs of cigarettes a day, or having sky-high cholesterol.”
What’s the problem?
After age 30, testosterone levels naturally decline by 1-2% per year. This is not a medical problem — it is a natural part of aging, and the body may have very good reasons for doing so. High testosterone can thicken the blood, increase the number of red blood cells, and elevate blood pressure, which significantly increases the risk of blood clots.
Information about side effects:
- Heart Attack
- Pulmonary embolism
- Deep Vein Thrombosis (DVT)
- Venous Thromboembolism (VTE)
- Organ damage