The group Public Citizen says the FDA should immediately add a "black box" warning — the most serious type — to all testosterone medications and require manufacturers to warn physicians about a higher risk of heart attack, stroke and death with the treatments.
This comes in light of recent studies that show that men over the age of 65 who have taken products such as Androgel to combat low testosterone (or “Low T) are at double the risk of having a heart attack.
In addition to the boxed warning, Public Citizen wants the agency to delay an approval decision on an experimental, long-acting testosterone injection called Aveed. The agency is scheduled to make a decision on the Endo Pharmaceuticals drug by Feb. 28.
Since 2009, sales of testosterone therapies have increased by 500%, topping $1.6b in U.S. prescriptions alone. FDA labeling on the drugs indicates they are only to be used for men who have abnormally low testosterone caused by a medical condition, But the latest advertising push by drugmakers is for easy-to-use gels and patches that are aimed at a much broader population of otherwise healthy older men with low levels of testosterone, the male hormone that begins to decline in the body after age 40.
Both AndroGel and Axiron have been aggressively advertised on television as a cure all for middle aged and elderly men who experience decreased energy and libido. However, the manufacturers can show little evidence of any medical benefit for men who use Low T drugs. There is a growing drumbeat from the medical community that Low T is an “invented condition” made up by the drug companies.
While a small minority of men do suffer from a condition called hypogonadism (a condition in which the body doesn’t produce enough testosterone), the makers of testosterone therapy treatments suggest in their advertisements that any male suffering from fatigue or low energy should be taking Low T drugs.
Consumers have already filed a string of Low T lawsuits after suffering heart attacks after taking Androgel and Axiron. Due to the possibility of a Low T class action lawsuit against the makers of testosterone gels such as the market leader Androgel, other public interest advocates have wondered if there will be a FDA testosterone recall.
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