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Testosterone Replacement Product Recalls & Warnings


August 07, 2019 07:17PM
Testosterone Replacement Product Recalls & Warnings




As of January 2019, a recall has not been issued for testosterone replacement products. However, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement on March 3, 2015, warning the public that testosterone therapy products are not approved for use in treating low testosterone as a result of aging. The FDA also required that the manufacturers warn about the increased risk of heart attacks and strokes.Steroids powder for sale

The FDA stated the following as part of its mandate: "The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man?s symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests." Reported in FDA Testosterone Safety Communication.
Testosterone therapy drugs are FDA-approved for the treatment of hypogonadism, a medical condition occurring in men where the male sex organs produce little or no testosterone hormone. Testosterone therapy is designed to work by replacing the absent naturally-occurring testosterone that is produced by the body.

Natural testosterone production in the body plays a significant role in male characteristics, mood, and sex drive. Men experiencing low levels of testosterone can have a number of unfavorable symptoms, including fatigue, low libido, and depression.

As men age, they may experience dips in testosterone levels, and it is part of the natural aging process to experience such an event. It is not a reason Testosterone therapy drugs were approved by the FDA, which is specifically for the medical condition hypogonadism.

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