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FDA Warns Testosterone Products Not for Age-Related Deficiencies

Based on the most current findings, the U.S. Food and Drug Administration (FDA) is mandating changes for labeling on all brands of prescription testosterone replacement products. Prior to a decision to start testosterone therapy or to continue taking testosterone replacement drugs, health care providers and medical professionals are supposed to make patients aware of the possible increased cardiovascular risks. New labels must reflect the possible increased risk of heart attacks and strokes associated with these medications.

The FDA became aware that doctors and other healthcare professionals were prescribing testosterone products to relieve symptoms in men with low testosterone levels due to no apparent reason other than natural aging. This is contrary to the FDA's previous warnings that testosterone replacement products were only approved for use in men with hypogonadism due to disorders of the testicles, pituitary gland or orbrain. Use of these products for age-related conditions of low testosterone has not been established and will require extensive clinical studies prior to approval.

Researchers initially identified a possible link between testosterone products and use in men over 65 while studying data from Truven Health Analytics which followed 56,000 men of all ages for their first 90 days of therapy. They were shocked that the risk for heart attack doubled in patients over 65 as well as for those under 65 who had a history of heart-related conditions. Again, following the same men for 90 days after they did not refill their prescriptions saw their risk rate for cardiovascular disease return to pre-therapy levels.

If you are over 65 or have a family history of heart problems, it is highly recommended that you get a second physician's opinion before opting for treatment with testosterone replacement products. If you've been diagnosed with a heart condition or have had a heart attack or stroke following testosterone therapy, it is important to seek legal counsel to discuss your options. Bob Grossman has been successfully representing victims of medical accidents caused by dangerous drugs for more than 35 years. Call our office in Houston, Humble or The Woodlands to speak directly with an experienced attorney.