In recent years, the number of prescriptions for testosterone replacement therapy products like Bio-T-Gel has skyrocketed. Unfortunately, enthusiasm has turned to concern after the FDA began investigating studies linking testosterone and an increased risk of stroke.
Bio-T-Gel and Strokes
Bio-T-Gel is a testosterone gel product that is applied directly to the skin. This is intended to treat men with hypogonadism (low testosterone), but studies indicate that only 50% of men on testosterone replacement therapy actually have hypogonadism. Many safety experts are concerned that the life-threatening risk of stroke may outweigh the benefit of using Bio-T-Gel for men without hypogonadism, especially if they have risk-factors for stroke.
Bio-T-Gel May Increase Risk of Stroke by 30%
The Journal of the American Medical Association (JAMA) published a study in November 2013 in which men on testosterone were 30% more likely to have a stroke, heart attack, or death in the first 90 days of treatment compared to men who did not use testosterone. On average, the men were 60 years old and many had heart disease. Two months after the study was published, the FDA published a Safety Communication and launched an investigation.
FDA Warns About Bio-T-Gel Stroke Risk
March 3, 2015 — The FDA has published a Safety Communication to announce that the makers of Bio-T-Gel 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 Bio-T-Gel is not approved for treating “Low T” due to aging. Click here to read more.
If you use Bio-T-Gel, 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 a Stroke?
Bio-T-Gel is associated with an increased risk of ischemic strokes, which occur when blood clots obstruct blood vessels in the brain. It may also increase the risk of transient ischemic attacks (or “mini-strokes”), which are temporary blockages in the brain (usually less than 5 minutes).
During a stroke, brain cells (neurons) do not receive blood, and they are “starved” of the oxygen they need to survive. After a few minutes, brain cells begin to die, causing irreversible brain damage. This causes disability in about two-thirds of patients, but symptoms vary widely depending on the part of the brain that is damaged. Some common complications include muscle weakness, speech problems, paralysis, memory loss, intellectual disability, problems walking, and more.
Symptoms of a stroke from Bio-T-Gel may include:
- Headache that starts suddenly, wakes you from sleep, occur when lying flat, or gets worse
- Loss of consciousness
- Changes in hearing, taste, vision, touch (ability to feel pain)
- Problems reading and writing
- Loss of muscle coordination, falling, or problems walking
- Numbness or tingling on one side of the body
- Drooping side of the face
- Problems speaking or swallowing
- And more