AndroGel (testosterone gel), manufactured by AbbVie, is marketed as a way to treat unpleasant symptoms of aging in men with low testosterone, or “Low T.” Unfortunately, new studies linking AndroGel and stroke have raised concern about life-threatening side effects, and AbbVie is accused of concealing these risks from patients.
What’s the problem?
AndroGel is advertised to treat vague and common aspects of aging — fatigue, depression, sexual dysfunction, reduced muscle tone, and more. These conditions affect millions of men as a complication of low testosterone, or “Low T.”
AndroGel is only FDA-approved to treat low testosterone in men who also have a serious medical condition, like a missing testicle, hypogonadism, chemotherapy, or a genetic disorder. However, only 50% of men on testosterone therapy actually have a serious medical condition like hypogonadism.
AndroGel and Strokes
The risk of stroke from AndroGel needs to be weighed against the benefits of treating “Low T” in millions of men. AndroGel makes several physiological changes that can increase the risk of stroke. It thickens the blood, increases the number of red blood cells, and increases blood pressure. If a blood clot forms in an artery above the heart, it can easily be pumped into the brain and cause a stroke.
FDA Warns About AndroGel Stroke Risk
March 3, 2015 — The FDA has published a Safety Communication to announce that the makers of AndroGel 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 AndroGel is not approved for treating “Low T” due to aging. Click here to read more.
If you use AndroGel, 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
AndroGel Linked to 30% Increased Risk of Stroke
AndroGel and other testosterone treatment products were associated with a 30% increased risk of stroke, heart attack, and death in a study published in the Journal of the American Medical Association in November 2013. Researchers estimated the 3-year cardiovascular event rate was 25.7% for men on testosterone and 19.9% for men not on testosterone. The average age was 60 and many participants had underlying heart disease.
What is a Stroke?
Ischemic strokes, also known as “brain attacks,” usually occur when a blood clot obstructs circulation to the brain. For every minute during a stroke, 2 million brain cells die from lack of oxygen. This can cause permanent brain damage, although the complications vary depending on the part of the brain that is damaged. Severe strokes can cause paralysis, speech problems, memory loss, and death.
AndroGel Stroke Symptoms
- Face droops on one side
- Arms drift downward when raised
- Speech is slurred or strange
- Muscle weakness, tingling, numbness
- Movement is uncoordinated
- Problems walking or balancing (falling)
- Vision is blurry or abnormal
- Headache (severe)