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FDA Mandating Tougher Warnings for Testosterone Drugs

The U.S. Food and Drug Administration (FDA) recently issued a warning regarding drugs used to treat low testosterone in men. The agency warns that the increasingly popular medications come with serious risks and now requires drug makers to add specific warnings to their labels.

In response to aggressive marketing campaigns, prescriptions for testosterone replacement drugs grew fivefold between 2000 and 2011. An estimated 1.5 million men have been prescribed medication to treat low testosterone or low-T, according to the Los Angeles Times. Most concerning, many men (25 percent) never had their testosterone levels checked prior to starting the medication.

In response to concerns over the use of testosterone drugs, the FDA recently issued a new safety alert. It states that the agency has “become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

Accordingly, the FDA is requiring that drug manufacturers change their labeling to clarify that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.

The FDA alert also highlights that the risks of testosterone products are not yet fully understood. Studies have found that they can increase the risk of stroke, heart attack and even death.

As we previously discussed on this San Diego Injury Blog, one study found an increased risk of heart attack in older men, as well as in younger men with pre-existing heart disease. Researchers reported a twofold increase in the risk of heart attack among men aged 65 years and older in the first 90 days following the first testosterone prescription.

To help patients fully understand the risks, drug labels must also disclose a possible increased risk of heart attacks and strokes in patients taking testosterone. The FDA is also advising health care professionals to consider whether the benefits of testosterone treatment are likely to exceed the potential risks.