Bio-T-Gel is a liquid underarm product that applies testosterone directly to the skin. This is a good treatment for low testosterone, but it may boost the risk of life-threatening side effects like heart attack. Recent studies have found that the risk of heart attack from testosterone may be 30% higher in the first 90 days of treatment — and older men with heart disease may have even higher risks.
Heart Attacks and Bio-T-Gel
Like all testosterone replacement products, Bio-T-Gel increases the risk of developing a blood clot. In most cases, these blood clots occur in the legs. They develop because testosterone increases the number of red blood cells, thickens the blood, and elevates blood pressure. These risk-factors also increase the risk of a heart attack.
Studies Linking Bio-T-Gel and Heart Attack
One of the first studies linking testosterone and heart attack was published in the New England Journal of Medicine in 2010. The study was halted prematurely after researchers found that older men in poor health on testosterone had five-times as many cardiovascular events — there were 23 events in the testosterone group, versus 5 in the placebo group.
In January 2014, the U.S. Food and Drug Administration (FDA) began investigating two studies linking testosterone and heart attacks. The FDA Safety Communication was published soon after PLOS One published a study linking testosterone to a doubled risk of heart attack for men over 65. JAMA also published a study linking testosterone to a 30% increased risk of heart attack, stroke, and death.
FDA Requires Warnings About Bio-T-Gel Heart Attack Risk
March 3, 2015 — In a Safety Communication, the FDA has required warning about the possible increased risk of heart attacks on the label for Bio-T-Gel and all testosterone replacement products. The FDA cautions that Bio-T-Gel is not approved or recommended for the treatment of “Low T” associated with aging. They are also requiring new clinical trials to assess the risk of heart attacks from Bio-T-Gel. Click here to read more.
Patients using Bio-T-Gel should seek medical attention immediately if symptoms of a heart attack or 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 Heart Attack?
During a heart attack, blood clots obstruct coronary arteries, which are the blood vessels that supply the heart muscle with oxygen-rich blood it needs to survive. The amount of tissue damage depends on the size of the area that was deprived of oxygen-rich blood.
Complications of a Heart Attack
Every year, thousands of people survive heart attacks. If the heart muscle is mildly damaged, it can heal within a few weeks or months. However, scar tissue does not pump very well, which weakens the heart. If the heart is too weak to circulate blood, the patient can develop heart failure or death.
Symptoms of a Heart Attack
- Chest pain or discomfort, which may spread to the neck, jaw, back, or arms
- Feeling may resemble back pain, indigestion, heartburn, “crushing,” squeezing, or heaviness
- Nausea, vomiting
- Dizziness
- Loss of consciousness
- Shortness of breath
- Changes in heart rhythm
- Anxiety
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