Group Urges FDA To Add Boxed Warning To Testosterone Drugs.

[Jasen Bruce]

Just received this news from Endocrine Daily newsletter . Hopefully the experts including those at ExcelMale keep putting the good word out so that this misinformation does not become standard
Group Urges FDA To AddBoxed Warning To Testosterone Drugs.

The AP (2/25, Perrone) reports that the groupPublic Citizen is urging the FDA to add a boxed warning “to populartestosterone drugs for men in light of growing evidence that the hormonetreatments can increase the risk of heart attack.” Dr. Sidney Wolfe of PublicCitizen's health group said, “It is quite clear that testosterone treatmentincreases the risks of cardiovascular diseases, including heart attacks.” Inthe petition, “Wolfe points to an analysis of 27 testosterone trials publishedlast April,” which “found that while 13 studies funded by drug companies didnot show an increase in heart problems, 14 non-industry funded trials showed atwo-fold increase in risk in heart problems.”

 

[Nelson Vergel]

I invite everyone to send a letter to the FDA stating some of the facts (cut and paste) here: https://www.excelmale.com/forum/thr...Management-of-Men-on-Testosterone-Replacement


Letter to the FDA: http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm

This is what I sent

Ref: Testosterone Cardiovascular Risk Studies and Possible Black Box Warning


We do not agree with adding a black box warning on testosterone products. This is why:


A study recently published that concluded that testosterone replacement therapy (TRT) can increase the risk of heart attacks in men shed lights on what happens when older men are given TRT without managing blood levels of certain well-known factors that can potentially affect their health. Men volunteering for this study, seeking to regain their vitality, were exposed to higher risks due to negligence and lack of compliance by researchers to current medical guidelines.


It is well known from 30 years of research that testosterone replacement can increase red blood cell (and hematocrit which is the total red cell volume) and estradiol production, two important factors for men's health when present in normal levels. Red blood cells carry oxygen and estradiol maintains healthy bones, cognitive function and sex drive. However, due to genetic, age or other factors some men can have excessive production of both while on TRT. Unfortunately, this study failed to manage hematocrit and estradiol. Furthermore, most men were not retested to have their testosterone blood levels optimized after they started TRT, so many of them may have remained with inadequate testosterone blood levels. Low testosterone blood levels have been shown to increase cardiovascular risks.


Additionally, this latest nonrandomized study states that "No data were available on indications for testosterone prescription, race, laboratory findings, occupational, environmental, or lifestyle factors." To jump to conclusions without knowing some of these factors is purely unethical.


Luckily, not all medical practices in the U.S. are ignoring proper monitoring of men on TRT. Many clinics are managing hematocrit by recommending blood donation or phlebotomies to men with hematocrit over 53 to decrease their red blood cell amounts. They are also recommending treatment with low dose anastrozole, an estrogen blocker, for men with estradiol over 50 pg/mL.


It is alarming that studies of this nature do not follow any of the main four testosterone treatment guidelines in the world. This table shows a summary of monitoring required by these medical groups showing the required frequency for monitoring men on TRT. These guidelines should also be revised to include estradiol testing.


It is imperative that future studies follow at least the minimum requirements from current guidelines. Are these studies liable for not following minimum guidelines and exposing their volunteers to increased risks?. Institutional review boards (IRB's) who approve these studies need to educate themselves about this problem so that no more studies are allowed that do not properly monitor men on testosterone replacement. Lawsuits from men who claim being exposed to unnecessary risks on TRT are starting spreading around the U.S. which may shed light on how poorly informed physicians and researchers are of the current TRT guidelines.


ExcelMale.com, an education and advocacy online platform focused on men's health, urges guideline groups to revise the current guidelines for testosterone treatment in men to include monitoring and managing estradiol with the same frequency as hematocrit. It also urge to enforce guidelines compliance in all testosterone studies and for the FDA to require testosterone manufacturers to support better education of physicians prescribing their products.


ExcelMale.com also encourages all men currently on testosterone replacement or thinking about starting it to educate themselves by visiting the site and to ensure that guidelines (along with estradiol monitoring) are followed by their physicians. We also warn men about signing any study consent form to volunteer in studies that do not specify the monitoring frequency and side effect management options provided by researchers.


We demand Abbvie (makers of Androgel), Auxilium (makers of Testim), Endo Pharmaceuticals (makers of Fortesta), Lilly (makers of Axiron) to stop this lack of compliance before they lose millions due to negligent practices and studies that do not follow minimum guidelines.


We are looking forward to the day when a research group will perform a well done study that not only gives testosterone to men but also one that retests them periodically to manage dose, high hematocrit and estradiol blood levels. It should not be a difficult task and it is the only responsible thing to do to generate conclusions that men and their providers can trust. As the testosterone replacement market grows rapidly, it is imperative to educate physicians, patients and researchers about minimum standards of care.