Actavis Inc. manufactures Androderm, a patch that delivers testosterone directly through the skin. Unfortunately, recent studies indicate that men on testosterone replacement therapy are 30% more likely to have a stroke (blood clot in the brain). Although many people survive strokes, over two-thirds result in brain damage and/or disability.
Androderm and Strokes
Androderm is a prescription testosterone replacement patch that is marketed to men with low testosterone (“Low T”). The Prescribing Information for Androderm includes information about blood clots in the legs. In fact, Androderm increases the risk of blood clots in several ways — elevating the number of red blood cells, which thickens the blood and increases blood pressure.
Androderm can also potentially increase the risk of ischemic stroke (blood clots in the brain) — especially for older men and those with pre-existing heart disease. Unfortunately, Actavis Inc. is facing criticism for marketing Androderm without sufficient warnings about stroke.
Research Links Androderm and 30% Higher Rate of Stroke
JAMA published a study in November 2013 linking the use of Androderm to a 30% increased risk of heart attack, stroke, and death in the first 90 days of treatment. The three-year risk of these events was 25.7% for men on testosterone replacement therapy, compared to 19.9% of men who did not use testosterone.
FDA Warns About Androderm Stroke Risk
March 3, 2015 — The FDA has published a Safety Communication to announce that the makers of Androderm and other testosterone replacement products must add warnings about the possible increased risk of stroke. They also must conduct clinical trials to study the risk of stroke. The FDA has emphasized that Androderm is not approved for treating “Low T” due to aging. Click here to read more.
If you use Androderm, seek emergency medical attention if symptoms of a stroke are present, such as:
- Chest pain
- Shortness of breath or trouble breathing
- Weakness in one part or one side of the body
- Slurred speech
What is an Ischemic Stroke?
There are two main types of stroke — hemorrhagic stroke (bleeding in the brain) and ischemic stroke (blood clot in the brain). Androderm is associated with ischemic strokes. These events occur when a blood clot obstructs circulation of blood to part of the brain, depriving cells of oxygen and nutrients they need to survive. For every minute that passes during a stroke, 2 million brain cells die. The resulting brain damage can cause a variety of complications — memory loss, speech problems, blindness, paralysis, organ damage, and even death.
- Mouth or face droops on one side
- Abnormal speech, forgetting words, or slurring speech
- Sudden problems understanding speech
- Sudden muscle weakness, numbness, tingling
- Loss of motor control, problems walking, or falling
- Blurry vision
- Severe headache
- When arms are raised, they drift downward unintentionally
- Loss of consciousness