FDA Updates Warning Label On Testosterone Supplements – Dr. David Samadi Explains The Changes

FDA Updates Warning Label On Testosterone Supplements – Dr. David Samadi Explains The Changes

The U.S. Food and Drug Administration (FDA) has once again revised and issued a warning to be placed on labels of prescription testosterone also known as testosterone replacement therapy, of the potential increased risk and dangers of serious health problems linked to the abuse of this supplement and related anabolic-androgenic steroids (AAS).

The concern stems from individuals abusing testosterone such as athletes and bodybuilders who may take doses much higher than prescribed and also tend to take them together with anabolic steroids. Anabolic steroids, a synthetic version of testosterone, may be prescribed to treat conditions such as delayed puberty, or diseases causing muscle loss such as cancer or AIDS.

The combination of abusing testosterone and AAS can lead to health safety risks including heart attacks, stroke, depression, liver toxicity, male infertility, and personality changes of increased hostility and aggression.

Withdrawal from the abuse of testosterone may result in depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.

“This not the first time the FDA has had to issue a warning to physicians and male patients regarding the use of testosterone,” explained Dr. Samadi. “In 2015 the FDA cautioned that prescription testosterone should be approved only for men who have low testosterone levels caused by certain medical conditions. This would include men who have low testosterone due to disorders of the testicles, pituitary gland, or a condition called hypogonadism. The crackdown came as a result of testosterone being used and abused extensively to reduce symptoms in men who have low testosterone due to natural declines associated with aging. In this case, there has been no established benefit shown or safety of this.”

The FDA stated the new warning is meant to remind and alert doctors of the potential abuse of testosterone and the risk of serious health problems. An important new addition to the label is to remind and advise doctors who suspect abuse to measure the patients’ blood testosterone levels before prescribing with no questions asked. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.

“Low testosterone in men manifests itself in numerous ways – lack of interest in sex or low libido, weight gain, they feel tired or lethargic, they lack motivation, and or have feelings of going through a “mid-life crisis,” exclaimed Dr. Samadi. “Just because a man exhibits symptoms is not an automatic right to testosterone. Every man should always have his testosterone levels checked before even considered for testosterone replacement therapy. What is disturbing is that up to 25% of men getting a prescription for testosterone have not had their testosterone levels checked.”

Supplements of testosterone can be taken in various forms either as pills, gels, or by injections and are currently used by millions of American men to boost their physical health or libido.

“For men who truly need testosterone due to low T, this can be life-changing,” stated Dr. Samadi. “All men’s testosterone levels decline about 1 percent a year after the age of 30 to where they eventually notice some changes. When a man’s testosterone levels are low, this is very critical as it can mean an increase in high cholesterol, heart disease, osteoporosis, Parkinson’s disease, and depression. But the key is it needs to be diagnosed and treated as men can do well on it as long as they take it as prescribed.”

Dr. Samadi went on to explain, “All men past the age of 50 should have their testosterone levels checked. But before we automatically write out a prescription for testosterone, each man should be looked at individually. I will evaluate their sexual functioning, infertility issues, changes in sleep habits, muscle strength, bone density, and if there is weight gain. From there, I can work on what is the best approach for treating low testosterone.”

Dr. Samadi further added, “I strongly believe men can look into natural ways of increasing their testosterone before right away using testosterone replacement therapy. We can discuss things such as losing weight, limiting alcohol, reducing stress, and making healthy dietary changes.”

Patients newly diagnosed with low testosterone or prostate cancer can contact world renowned prostate cancer surgeon, men’s health expert and urologic oncologist, Dr. David Samadi on 212-365-500 for a free phone consultation or learn more by visiting ProstateCancer911.com

Dr. David Samadi | Robotic Prostate Surgeon


ProstateCancer911.com is a resource created by Dr. David Samadi in order to raise awareness and get more men to receive prostate cancer treatment. The information is strictly general and you should always discuss with your doctor issues concerning your health.


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