FDA Warns Of Testosterone Supplement Dangers

The Food and Drug Administration recently ordered testosterone supplement manufacturers to add warnings about the risk of drug dependence and possible side effects.

Doctors may prescribe steroids to certain patients who suffer from certain medical conditions. However, many doctors also give these drugs to men over 40 who have symptoms of “male menopause,” even though there is comparatively little evidence that such a condition indeed exists. The federal government, and most state governments, classify anabolic steroids as Schedule III dangerous drugs because they are very addictive, especially if taken beyond what the doctor orders. Additionally, recent evidence has established additional links between testosterone supplements and serious side effects, including heart failure, personality changes, and liver disease.

A little over 6,000 cases have been consolidated in the Northern District of Illinois, and the first bellwether trial is set to begin in June 2017.

Off-Label Use

When the FDA approves a new drug, it often advises doctors to limit the drug to certain conditions in certain patients. However, drug makers usually encourage “off-label” experimental use to increase sales. Primarily, that’s because manufacturers must spend roughly $2.6 billion in clinical trials and other tests before the FDA will approve a new drug; that figure has increased 145 percent in the last ten years. To recoup these costs and show a profit, the manufacturer must sell as much product as possible in a very short window, because lawmakers recently enabled generic drug makers to make lower-priced copies more quickly, in many cases.

In terms of testosterone supplements, doctors normally prescribe steroids to treat anemia and other serious conditions, but because largely anecdotal evidence suggests that testosterone boosts mood and has other beneficial side effects, some doctors prescribe these drugs to treat lethargy and other symptoms. Experimental medical procedures are always riskier than approved procedures, so doctors are held to a higher legal standard when prescribing medicine off label.

Testosterone Supplements

Several years ago, pharmaceutical companies unleashed a massive advertising campaign about the effects of “low T” and the purported benefits of testosterone supplements. But contrary to these claims, doctors recently concluded that these treatments had little or no effect on libido, mood, or physical function. Additionally, these powerful drugs have been consistently linked with:

• Heart Attacks: In one study, only 90 days of testosterone therapy doubled the risk of heart attacks in older men; in a previous study, one man actually died of a testosterone-induced heart attack before doctors released the results.
• Strokes: Excessive testosterone causes blood cells to enlarge, raising the risk of TIA (transient ischemic attacks) mini-strokes.

Victims in dangerous drug cases are entitled to compensation for their economic and noneconomic damages. Additionally, jurors often award large punitive damages in these cases, and there is no cap on these damages in Kentucky, in many cases.

Contrary to the manufacturers’ claims, testosterone supplements are largely ineffective and highly dangerous. For a free consultation with an experienced personal injury attorney in Glasgow, contact Attorney Gary S. Logsdon. We normally do not charge upfront legal fees in negligence cases.