FDA warning: Avoid overuse of testosterone

The FDA has issued a warning to physicians and male patients regarding the use of testosterone drugs, which they say have an increased risk for heart attacks and strokes. The FDA is urging doctors and the companies that make these testosterone drugs to warn patients about the potential life-threatening risks they pose.

The FDA’s warning comes after discovering that testosterone drugs are not always being used as a form of treatment for low testosterone caused by certain medical conditions, but rather to treat symptoms of low testosterone as a result of aging, such as fatigue and low libido. The FDA has not determined what benefits and safety in using testosterone products for treating symptoms of low testosterone due to aging. For this reason, the FDA wants doctors to prescribe testosterone only to men who are suffering from low testosterone that is caused by a medical condition which has been confirmed by laboratory tests.

Testosterone Replacement Therapy Overload

The overuse of testosterone drugs are unsafe for men with age-related diseases, according to the FDA. The types of testosterone drugs they warn against are testosterone boosting drugs, also known as testosterone replacement therapy. These work to increase the amount of testosterone in the body. For men suffering from issues like fatigue and low libido, it is unclear whether testosterone boosting drugs are actually beneficial and safe.

There are millions of men who are using these testosterone drugs who are unaware of the potential health risks and side effects. The FDA wants to make sure the labels of these products make it clear to consumers that they are only meant for treating low testosterone caused by a medical condition. Low testosterone as a result of a medical condition often occurs after an injury or when suffering from a disease.

New Study: Dangers of TRT

A study published in the Journal of American Medical Association (November 2013) found a 30 percent increased risk of death, heart attack or ischemic stroke among men who were taking testosterone replacement drugs, compared to men who were not taking them. Another study from the National Institute of Health found that men over 65 who were taking testosterone replacement drugs had twice as many heart attacks compared to men who were not taking them.

In 2013, testosterone replacement drugs generated over $2 billion in the United States, according to IMS Health. This is a significant jump in the last ten years. The FDA estimates that 1.5 million men were taking a testosterone replacement product in 2013, which is almost double the amount of men taking them in 2010. About 25 percent of these men had not been tested for or diagnosed with hypogonadism (low testosterone), meaning they were taking the drug based on symptoms, rather than a diagnosed medical condition. 

The FDA says that the risks associated with testosterone replacement drugs are not fully understood and that with the market growing so quickly, it’s important to determine exactly what they are. The risks we are currently aware of include an increased risk for blood clots and stroke, sleep apnea, acne, breast enlargement, and possibly an increased risk for prostate cancer, according to WebMD. 

Who suffers from low T?

Millions of men suffer from low testosterone as they age; it is a common and natural part of the aging process. Symptoms include low libido, erectile dysfunction, reduced energy and depression, and loss of muscle mass. For an adult male, the normal testosterone level should be between 300 and 1,000 ng/dL. Testosterone replacement therapy in the form of gels, injections, patches or pills can help increase the testosterone level until it is within normal range. Testosterone replacement therapy can increase libido and ability to maintain an erection, increase bone strength, improve osteoporosis, improve mood and energy, and reduce irritability and anger.

FDA Approval of Testosterone Drugs

The FDA has approved testosterone drugs only to treat medical conditions where the testicles are incapable of producing testosterone naturally. This can sometimes happen after chemotherapy, but is also often a genetic related issue. The FDA has yet to approve testosterone drugs to treat age related problems. FDA: “We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications.”

For now, be cautious about using testosterone drugs to treat low testosterone symptoms as a result of aging. They should only be used to treat a diagnosed medical condition that has been confirmed by a blood test or other lab test. Testosterone products should also only be taken under the supervision of a doctor who has prescribed it to you.