Worried About Warning Labels on Testosterone Products?
New FDA label based on flawed research may scare men away from necessary treatment.
Last month, the FDA announced that it will require prescription testosterone products to carry a label warning that testosterone therapy may increase the risk for heart attack and stroke. This decision has been criticized by many doctors and researchers as a move that will only add to the confusion surrounding testosterone replacement therapy and perhaps even prevent men from getting needed treatment.
According to one respected men’s health expert, Abraham Morgentaler, the FDA warning is “bad news for men” that will present a serious obstacle to men suffering from true testosterone deficiency.
So why is the FDA requiring this label? Once again, the 2013 JAMA study is rearing its ugly head. This flawed study was picked up by the media and consumer lobby groups and used to justify all kinds of claims regarding the dangers of testosterone to heart health. It has since been “supported” by other studies also allegedly linking heart problems and testosterone therapy.
Morgentaler recently published an analysis in the journal Mayo Clinic Proceedings, presenting his findings on the topic. He found no increase in heart risks for men taking testosterone as part of a quality treatment protocol. He also noted the significant flaws and limitations present in the 4 studies commonly cited in support of the FDA warning. Renew Man™ did our own investigation into the limitations of the JAMA study, which you can see here.
The one bright spot in this whole debacle is that it provides an opportunity to distinguish between safe and unsafe testosterone replacement therapy. Unsafe therapy can present risks, and should certainly be avoided. Just remember, it is the flawed treatment protocols, not the testosterone itself, that presents the risk. Healthy levels of testosterone are actually good for men’s hearts.
Dangerous Practices to Avoid
Treatment without Testing: In the JAMA study, 25 percent of the men receiving testosterone replacement therapy had never been tested for low testosterone. This is unsafe and irresponsible. Men need to be tested to confirm that they do in fact have low testosterone and to determine how much testosterone needs to be replaced in order to achieve a healthy balance. Additional testing should be done periodically as treatment progresses.
Synthetic Hormones: Because synthetic hormones have been linked to cancer and other adverse outcomes, it is essential that any responsible hormone therapy provider only use bioidentical hormones.
Patches & Pills: Testosterone injections are the most effective means of delivery for low T therapy. Injections ensure a slow and steady supply of testosterone, while patches and pills can lead to unhealthy spikes and troughs in testosterone levels.
Treating Testosterone Alone: In some men, testosterone replacement can increase hematocrit levels in the blood. It is important to test and manage hematocrit levels to protect against stroke. Levels of other vital hormones such as estrogen must also be tested and managed for a safe and effective therapy. Neither of these steps were taken in the JAMA study.
Renew Man’s™ Therapy is Safe
At Renew Man™, we incorporate all of the best practices for testosterone replacement therapy and none of the dangerous practices that have caused some studies to reach such wrong conclusions. You can rely on our therapy to provide the results you want with none of the risks you fear. Please contact us at 800-859-7511 with any questions.