Testosterone Gets Black Box Warning to Protect Children from Increasing Penis Size

[Millard]

The U.S. Food and Drug Administration (FDA) is requiring the manufacturers of the topical testosterone gels AndroGel and Testim to include a “black box warning” on its labels in order to “protect children” from the potentially adverse effects of this particular anabolic steroid. The “black box warning” is the FDA’s most serious warning short of [...]

FDA Gives Testosterone Gel Black Box Warning to Protect Children from Increasing Penis Size - MESO-Rx

The U.S. Food and Drug Administration (FDA) is requiring the manufacturers of the topical testosterone gels AndroGel and Testim to include a "black box

thinksteroids.com

 

[flmedic911]

I dont really see anything wrong with extra security measures....if im reading what you posted the right way.

FLMEDIC911

 

[Millard]

I dont really see anything wrong with extra security measures....if im reading what you posted the right way.

FLMEDIC911

Every government regulation involving steroids is purportedly an additional security measure. The FDA could have even taken it a step further and issued a product recall in the interest of extra security measures. The questions are where do you draw the line? And are policies uniform and consistent for all drugs? Or are steroids targeted via fear/hysteria campaigns? These are important questions when evaluating government/regulatory action involving steroids.

 

[Jeton]

Every government regulation involving steroids is purportedly an additional security measure. The FDA could have even taken it a step further and issued a product recall in the interest of extra security measures. The questions are where do you draw the line? And are policies uniform and consistent for all drugs? Or are steroids targeted via fear/hysteria campaigns? These are important questions when evaluating government/regulatory action involving steroids.

ur certainly correct about the need for vigilance with regard to any new government regulations of AASteroids, but in this case a black box warning was frankly overdue. the effects of AAS in children can be quite harmful and varied, and the awareness level is low.

one of the reasons i switched off transdermal gels and onto injections is because it was so easy to rub off gel on people (and clothes and anything else). neither my doctor at the time nor my pharmacy gave me any child- or women-specific warnings that i can recall...i just happen to be the kind of guy that reads drug package-inserts carefully and repeatedly. most people dont. also, i already had some idea of how harmful AAS can be in children-- again, most people dont.

all told, i think the black box warning was a good idea to inform more people of an underappreciated and dangerous potential side effect. while it may indeed lead to more indesirable restrictions, that's a function of the overall AAS hysteria we must fight and not the black box warning itself. there are many non-controlled-substance FDA approved medications with black box warnings...the warning label by itself does not make a medication any harder to get.

are u against the warning itself or do u see it as a preamble to more restriction?

 

[Millard]

ur certainly correct about the need for vigilance with regard to any new government regulations of AASteroids, but in this case a black box warning was frankly overdue. the effects of AAS in children can be quite harmful and varied, and the awareness level is low.

one of the reasons i switched off transdermal gels and onto injections is because it was so easy to rub off gel on people (and clothes and anything else). neither my doctor at the time nor my pharmacy gave me any child- or women-specific warnings that i can recall...i just happen to be the kind of guy that reads drug package-inserts carefully and repeatedly. most people dont. also, i already had some idea of how harmful AAS can be in children-- again, most people dont.

all told, i think the black box warning was a good idea to inform more people of an underappreciated and dangerous potential side effect. while it may indeed lead to more indesirable restrictions, that's a function of the overall AAS hysteria we must fight and not the black box warning itself. there are many non-controlled-substance FDA approved medications with black box warnings...the warning label by itself does not make a medication any harder to get.

are u against the warning itself or do u see it as a preamble to more restriction?

I've strongly advised parents of young children to avoid topical testosterone for over 4 years.

applying Androgel

The real risk is unclear, but as a parent, I don't think you can be too cautious when it comes to inadvertently exposing your children to androgens during a critical development period.

This is part of responsible parenting. I fault ignorant doctors for not educating their patients about potential risks of testosterone gels to others. I fault the pharmaceutical companies and their reps who aggressively pushed Androgel (because of the high profit margins over general testosterone enanthate/cypionate injectables for same purpose) to doctors and health care providers.

My personal experience with the issue... I went to three doctors before a doctor would prescribe me injectable testosterone over Androgel. The first two doctors ONLY wanted to prescribe Androgel EVEN AFTER I explained my concern about inadvertently exposing others to androgens. This was because they were ignorant about androgens, they were afraid of prescribing androgens, they were told by pharm reps that androgel was always best solution.

It seems like common sense that if you use a gel that can be absorbed through YOUR skin, then of course it can be absorbed through OTHERS skin too. Anyone who has used gels, know that they are very messy, they get all over your hands, the drug packaging, on faucets, on counters, etc.

As far as government regulation is concerned... No, I don't think the black box warning is appropriate in this case. It is not the purpose of FDA boxed warnings.

And I think the argument that "if you're against it, then you're against protecting children" is a bogus argument that is used too often to push ill-conceived emotional/hysteria-driven legislation/regulations.

Even after expressing my own personal concerns about Androgel, I don't think the risks are as great as indicated by the 8 cases cited by the FDA. In the past 50 years or so, a lot of research has purposely given androgens to children without such extreme side effects. Such side effects do not seem likely from occasional contact with parent who has androgel on skin. It seems more likely that children may have seen their father use the cream/gel and mimicked them when the child obtained the gel from an easily accessible location.

Still, the black box warning is not intended for powerful drugs that can cause side effects in people other the prescription-holder (i.e. children) simply because parents can not responsibly use and/or securely store the medication. Otherwise, we would have additional black box warning on dozens of drugs especially psychoactive drugs that have a high likelihood of diversion by teens searching through their parents medicine cabinets.

 

[Jeton]

i'm gonna number your points and my responses for clarity:


1) i agree with you about responsibility falling on parents and doctors.

2) i also agree that doctors are too easily manipulated by the reps of pharma companies, and by general public hysteria...which can also be augmented by ignorant medical boards when AAS are involved.

3) common sense isn't always common.

4) i disagree, black box warnings are used when the FDA gets reports of serious side effects and the FDA feels those side effects are under-appreciated among doctors and patients...whether it's the risk of tendon rupture with flouroquinolones like Cipro, excessive bleeding on Warfarin, actually dying of cancer from Tacrolimus, or causing hormonal disruptions in children and women via t-gels.

5) i never made that accusation, and take your assertion of warning of t-gel side effects at face value. However, i do think that fighting the black box warning in this case is a losing battle, and if you appeared on a news program with some frothing anti-AAS activist giving counterpoint, i suspect THEY would milk the "you don't care about children" angle, and any moderating host would have to ask you "c'mon, where's the real harm in just warning people?"

6) i expect that there probably are cases of children applying their parent's t-gel directly, but i doubt that accounts for all cases...and i suspect not all cases of children exposed to adverse levels of t-gel have even come to the FDA's attention. Most coverage of hormone disruptions in children have focused on the substantial variability in response form child to child, whether it's from medically supervised hormone therapy or from aggregate exposure to things like xenoestrogens in livestock and dairy products producing morphological disruptions like premature menstruation in girls and feminizing effects in boys.

of course i also wouldn't be surprised if there was the occasional parent stupid enough to make their children use such medication, whihc would of course be abuse. in any case, I'd imagine the FDA running through a few of these scenarios (and points 1-3) and deciding that a black box warning couldn't possibly hurt and might help.

7) actually i'd expect the FDA to consider controlled-substance labels and other warning labels applied to med-bottles at a pharmacy sufficient in most circumstances...ironically, overall anti-drug hysteria better serves their purpose in that regard than a black box warning could. it may very well be that Androgel's and Testim's successful marketing as safer" and less offensive than injectable T was a critical factor in getting the FDA to issue the black warning as a caveat.


anyway, i'm still curious if your animus against this move is purely procedural ("black box warnings are not supposed to be used THAT way!") or if you think this warning could/will serve as a pretext for more overall restriction and enforcement...

thanks for the thorough response btw, and my noobie-howdies to your Admin-highness.

 

[Millard]

Thank you for taking the time to read my comments and article and give your thoughtful responses and reactions. I think we are more in agreement on this issue than you think.

My primary objective is to highlight action that I don't think would have been otherwise taken if it were not for the negative attention given to steroids in recent years. If it weren't for the hysteria, I don't believe that the FDA would have ever acted. I think the risk for endocrine disruption is just as serious for EstroGel and related transdermal delivery systems, yet I don't see a similar black box warning.

My point is anabolic-androgenic steroids are discriminately targeted, nothing more, nothing less.

I particularly agree with you that THIS is not a battle worth fighting and I have NO INTEREST whatsoever in making the revocation of the black box warning part of my agenda. Not my intent. I hope to encourage people to critically examine all government regulations of steroids. Because in many cases, but not all, well-meaning regulation that "couldn't possibly hurt and might help" does have unintended negative consequences.

I think the issue you raised about the effects of xenoestrogens in our society is a major health issue. I wish we could re-prioritize focus on steroids in sports to this issue.

 

[Jeton]

1) Thank you for taking the time to read my comments and article and give your thoughtful responses and reactions. I think we are more in agreement on this issue than you think.

2) My primary objective is to highlight action that I don't think would have been otherwise taken if it were not for the negative attention given to steroids in recent years. If it weren't for the hysteria, I don't believe that the FDA would have ever acted. I think the risk for endocrine disruption is just as serious for EstroGel and related transdermal delivery systems, yet I don't see a similar black box warning.

3) My point is anabolic-androgenic steroids are discriminately targeted, nothing more, nothing less.

4) I particularly agree with you that THIS is not a battle worth fighting and I have NO INTEREST whatsoever in making the revocation of the black box warning part of my agenda. Not my intent. I hope to encourage people to critically examine all government regulations of steroids. Because in many cases, but not all, well-meaning regulation that "couldn't possibly hurt and might help" does have unintended negative consequences.

5) I think the issue you raised about the effects of xenoestrogens in our society is a major health issue. I wish we could re-prioritize focus on steroids in sports to this issue.

1) oh i've been sure our goals are similar, i just wasn't sure i could get clear answers without incurring admin-wrath...my experiences elsewhere leave me slightly paranoid. i'm happy to know you can argue without taking offense...no small feat for many people.

2) an interesting point that gives me a mixed reaction. i suspect that reports of endocrine disruptions in children are inherently alarming for regulators, so i suspect that t-gel would eventually earn a black box warning regardless of steroid hysteria...it may also be appropriate for Estrogel, whihc i didnt know existed until now. i save a further reaction here for point 5...

3) agreed...but i think it points to political faultlines that also get exposure in pt 5...

4) i concede the need for relentless critical appraisal, but until now it wasn't clear whether u considered this warning "battle worthy".

5) the political faultline i see here is almost literally the hippies and straight-edges battle transposed. thru the efforts of a few busybodies and a few more ignorant AAS users, AAS have been successfully cast by mass media into just one more drug for those damn "not-good-guys"...literally a dangerous indulgence transgressing America's eternally Puritan undercurrent. whereas hostility to xenoestrogens involves holding many different Corporate interests to account.

it's an interesting set of ironies...anti-drug hysteria has it's strongest legacy from the hippy era, when drugs were considered corrosive of manhood, capitalism and traditional values... yet now the biggest threats to longterm health and manhood on Earth come from companies that wrap themselves up in conservative images, and those same companies (and the politicians they own) cast aspersion on (pinko/commie) environmental enforcement that would curb the damage those companies due to (especially male) humans.... meanwhile medications that abet or enhance health and/or masculinity are associated with dangerous self-indulgence and counter-culture.


since a general backlash has grown in the USA against knee-jerk anti-environmentalism, it will help to transpose some of that justifiable skepticism over to the frothing anti-AAS crowd. that's why Stossel's 20/20 report on Friday was so exciting, even if it was very brief and incomplete.

 

[Jeton]

oh hey, i just wanted to add that i tried to catch ur radio appearance tonite n couldn't. i got an email at 10:12pm EDT saying that the show you'd be appearing on would air at 9pm PDT, whihc i assumed would be midnite east coast time...but instead i'm hearing a long commercial on kfwb.com since midnite, and your twitter page says you were already on!

do u know if there's a stream or podcast of that show i might catch?