FDA Warns of Heart Attack and Stroke Risk with Low T Testosterone Products
Monthly Prescribing Reference reports that the Food and Drug Administration, FDA, has announced that testosterone products will have to change their labels to warn of an increased risk for heart attack and stroke.
About the Testosterone Product Label Changes
The FDA notes that testosterone products are approved only for treating low testosterone associated with disorders to the testicles, pituitary gland, or brain resulting in hypogonadism.
Bloomberg reports this change affects all testosterone products including AndroGel, made by AbbVie, and Axiron, made by Eli Lilly.
The announcement of label changes, warning of heart attack and stroke risk, comes after the FDA announced in January 2014 that the agency would be investigating the cardiovascular safety of testosterone products, according to Medscape.
Serious Adverse Effects Associated with Testosterone Products
The Wall Street Journal reports that the label change warning of increased heart attack and stroke risk with testosterone products comes after Canada issued a similar warning about the heart risks of testosterone products last year.
The FDA also wants to make sure that the labels for testosterone products specify that these drugs should not be used to treat signs of aging and are only for low testosterone levels associated with a medical condition, reports NPR. Forbes reports that the benefit of using testosterone products to treat signs of aging have never been tested and that it is unclear if these drugs are safe when used in this manner.
Sales of testosterone products have quadruple since the early 2000’s due to advertisements suggesting that these drugs will cure signs of aging, according to the New York Times. BioPharma Dive reports that for years, testosterone products were marketed as a “cure-all” for aging.
This is not the first time that the FDA has issued a safety warning for testosterone products; in June 2014, the agency issued a warning for increased risk of venous blood clots, according to Medscape. In the warning, the FDA reports that use of testosterone products increases the risk of venous thromboembolisms, including deep vein thrombosis and pulmonary embolisms, whether or not the person develops polycythemia, a thickening of the blood.
Studies Show Testosterone Products Increase the Risk of Death, Heart Attack and Stroke
A study published in the prestigious Journal of the American Medical Association found that use of testosterone products increased the rates of death, heart attacks, and strokes in men using the products by 30% compared to men who did not use the drugs, according to FiercePharma.
The FDA is following the lead of its advisory committee, which voted 20-1 to warn about cardiovascular risks and to conduct safety studies, by requiring manufacturers of testosterone products to conduct additional clinical trials to determine the extent of the cardiovascular risk associated with their products, according to NPR.
In the safety announcement about the increased risk for heart attack and stroke with testosterone products, the FDA advises that any person taking testosterone products and experiencing the signs and symptoms of a heart attack or stroke should seek emergency medical help.
The National Institutes of Health explains that heart attacks can have a wide range of signs and symptoms, but the most common are:
- Chest pain
- Upper body discomfort
- Shortness of breath
- Trouble breathing
- Feeling tired
- Cold sweat
- Light headedness/dizziness
The National Stroke Association reports that the following are signs of a stroke:
- Numbness or weakness affecting the face, an arm, a leg, or one side of the body
- Trouble speaking
- Sudden confusion
- Trouble seeing out of one or both eyes
- Trouble walking
- Trouble understanding
- Terrible headache
RECENT CLINICAL DRUG TRIAL RESULT
$7.2 MillionExpenses: $24,838.25 | Attorneys Fees: $2,200,000.00 | Net to Client: $3,275,161.75 (Purchase of a Lifetime Annuity)
RECENT CLINICAL DRUG TRIAL RESULT
$4 MillionExpenses: $24,856.98 | Attorneys Fees: $1,600,000.00 | Net to Client: $2,375,143.02