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Earlier this year, the FDA issued a Drug Safety Communication alerting the public of its investigation into “Low Testosterone Therapy” medications. These drugs were FDA approved ONLY for men “who lack or have low testosterone levels in conjunction with an associated medical condition.”. However, these “therapies” are marketed to all men who have decreased sex drive, lack of energy, decreased strength/endurance, or a decrease in “enjoyment of life.”
Following studies published earlier this year, the FDA warned health care professionals to consider “whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.”
Just recently, in June of 2014, the FDA released another MedWatch safety alert for “testosterone products.” In its most recent warning, the FDA notified health care professionals and medical care organizations that it is requiring manufacturers to include warnings in drug labeling about the risk of blood clots in veins, specifically clots in the lower extremities (legs). This new warning expands the current warnings already listed for testosterone therapy medication.
Although this new warning, or class label change, is not directly related to the ongoing investigation into claims that testosterone medication increases the risk of heart attack, stroke, or death, it is a strong signal that the FDA is vigorously investigating these claims.
Written By: Attorney Jordan Lebovitz
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