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Fortesta Stroke Information


Testosterone replacement products, including Fortesta, have become controversial. Although Fortesta is effective at treating unpleasant symptoms of low testosterone, experts are concerned about life-threatening side effects like ischemic stroke (blood clots in the brain).

Fortesta and Strokes

Fortesta is a testosterone gel product that is applied directly to the skin. One side effect is an increase in the number of red blood cells, which can thicken the blood, elevate blood pressure, and increase the risk of a blood clot. If a blood clot travels to the brain or grows in a narrow artery, it can potentially cause an ischemic stroke or transient ischemic attack.

FDA Warns About Fortesta Stroke Risk

March 3, 2015 — The FDA has published a Safety Communication to announce that the makers of Fortesta 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 Fortesta is not approved for treating “Low T” due to aging. Click here to read more.

If you use Fortesta, 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

30% Increased Risk of Stroke, Heart Attack, Death

In November 2013, Journal of the American Medical Association published a study that sparked an FDA investigation into the stroke risks of testosterone replacement therapy. Researchers evaluated data on over 8,700 men with low testosterone, including over 1,200 on testosterone therapy, from 2005-2011. They found the men on testosterone were 30% more likely to have a heart attack, stroke, or death.

What is a Stroke?

Ischemic strokes occur when a blood clot obstructs circulation of oxygen-rich blood in the brain. When they involve a blood clot that grew in another area of the body and traveled to the brain, they are called cerebral embolisms. When blood clots grow inside the brain and clog a narrow artery, they are thrombotic strokes. Transient ischemic attacks occur when blood clots block circulation for just a few minutes and then resolve on their own.

In all strokes, brain cells (neurons) are deprived of oxygen-rich blood. After a few minutes, neurons begin to die. This causes permanent brain damage. The symptoms and long-term complications depend on the part of the brain that does not receive oxygen and the time elapse until treatment.

Stroke Symptoms

  • Numbness or weakness in the legs or arms
  • One side of the face droops
  • Problems seeing on one or both eyes
  • Problems walking, balancing, or falling
  • Dizziness
  • Sudden severe headache


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