All About Oxandrolone

[SteveCleves]

Correct me if wrong....if it is in the orange book then compounders can have at it.


where do you get your steroids? (USA)

OXANDROLONE now listed as discontinued in all forms in orange book. But so is nandrolone and that's still being compounded.

So I am going risk assuming that if it's in the orange book, even if its discontinued, it can still be compounded.

 

[SteveCleves]

That drug did a lot of good for women with HIV wasting. Here is a presentation I gave at a conference in Cannes.

https://www.researchgate.net/publication/248496262_Oxandrolone_Anabolic_steroid_use_in_HIV_positive_women

I wonder how much its used now that HIV has become a manageable disease. I don't know, but is wasting still an issue with the current HIV treatments?

So it seems like the only mainstream use case is burn victims? I would be curious to know how much it's even used in those cases.

 

[Nelson Vergel]

Oxandrolone is the most studied androgen besides testosterone. I am attaching a great review of data from many studies that found no liver toxicity. Some reversible transient AST and ALT elevations (which we have also seen with resistance exercise alone) were seen in a few studies. Read page 737 on.

 

[tareload]

OXANDROLONE now listed as discontinued in all forms in orange book. But so is nandrolone and that's still being compounded.

So I am going risk assuming that if it's in the orange book, even if its discontinued, it can still be compounded.

Here's the kicker....

Federal Register :: Request Access

We will see. Good question.

 

[Nelson Vergel]

Great find ! @readalot

I guess compounders will have to fill a Citizens Petition for oxandrolone. Something tells me it will not have the same outcome as nandrolone unless they do a good job at explaining that hepatic effects are seen at high doses and long term exposure.

 

[Sly]

Hey, don’t worry the FDA will still let you buy alcohol and cigarettes because those are obviously safe.(sarc)

 

[tareload]

would be curious to know how much it's even used in those cases.

Pretty good amount of recent literature in this burn group. Very useful tool.

@Nelson Vergel probobaly not needed but happy to help with lit review refuting the BS above. Not a very scholarly review of what is available in the Fed Register link from madman's post but of course that was not the purpose.

 

[tareload]

@SteveCleves

Oxandrolone in the Treatment of Burn Injuries: A Systematic Review and Meta-analysis - PubMed

Severe burns induce a profound hypermetabolic response, leading to a prolonged state of catabolism associated with organ dysfunction and delay of wound healing. Oxandrolone, a synthetic testosterone analog, may alleviate the hypermetabolic catabolic state thereby decreasing associated morbidity...

pubmed.ncbi.nlm.nih.gov

A Reappraisal of Oxandrolone in Burn Management - PubMed

<span><b>Objective:</b> Burn injuries remain among the most severe traumatic injuries globally. With the discovery of cortisol, the use of steroids has become an essential therapy for the management of inflammatory and metabolic conditions. Several studies have shown the steroid oxandrolone...

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of oxandrolone treatment for patients with severe burns: A systematic review and meta-analysis

The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of using oxandrolone in patients with severe burns.P…

www.sciencedirect.com

Effects Of Oxandrolone On Lean Body Mass (Lbm) In Severe Burn Patients: A Randomized, Double Blind, Placebo-Controlled Trial - PMC

In severe burns, hyper-metabolic conditions due to elevation of pro-inflammatory cytokines and stress hormones usually occur. Unregulated hypermetabolism can lead to muscle protein catabolism, inducing weakness, infection, and delayed wound healing. ...

www.ncbi.nlm.nih.gov

Novel pharmacotherapy for burn wounds: what are the advancements - PMC

The prognosis for severe burns has improved significantly over the past 50 years. Meanwhile, burns have become an affliction mainly affecting the less well-developed regions of the world. Early excision and skin grafting has led to major ...

www.ncbi.nlm.nih.gov

Liver injury?...
5 years at 50 to 100 mg/day maybe. Not applicable to clinical use.Of course the lipids would be my primary concern.

Another railroading by FDA. Pathetic review of data and literature to date in June 23 memo.

 

[tareload]

Comprehensive list all in one spot:

FDA approved, discontinued androgens (FDA orange book)

FDA has just approved norgestrel (progestin) for OTC but all Pharma versions of oxandrolone have been discontinued. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information Ignorance sure must be bliss.

www.excelmale.com

 

[Deleted member 43589]

Hey, don’t worry the FDA will still let you buy alcohol and cigarettes because those are obviously safe.(sarc)

But the FDA want to investigate energy drinks. Especially if you put them in pink bottles.

 

[Nelson Vergel]

Any thoughts, comments, or edits? Planning to send this letter.

Alexandria Fujisaki
Regulatory Counsel, CDER
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Ms. Fujisaki,

I am writing to express deep concern over the recent decision to notify oxandrolone manufacturers that the FDA believes the potential risks associated with this drug are severe enough to warrant its removal from the market. As an informed citizen, I would like to present a case that highlights the important positive and safe uses of oxandrolone for various medical conditions.

Oxandrolone, a synthetic derivative of testosterone, has been used effectively to promote weight gain in patients experiencing HIV wasting syndrome. Several studies, such as that by Grunfeld et al. (2006)[1], have demonstrated that oxandrolone, along with adequate nutrition, significantly increases body cell mass and muscle size in these patients with no hepatotoxicity.

Furthermore, this medication has been safely used to counteract protein catabolism caused by long-term corticosteroid therapy (Goldberg, et al., 1996)[2]. It's also proven to be effective in supporting recovery from severe burns, greatly improving lean body mass, bone mineral content, and muscle strength (Jeschke, et al., 2005)[3].

Notably, oxandrolone is used for the treatment of bone pain related to osteoporosis, enhancing both bone density and quality of life in patients (Bonaiuti, et al., 2002)[4]. It also plays a significant role in the development of girls with Turner syndrome, boosting height velocity and adult height (Menke & Sas, 2010)[5].

Safety and side effect profiles are important considerations for any medication, and it is crucial to remember that oxandrolone has been found to have a favorable safety profile. Studies have demonstrated no liver toxicity when used at clinically effective doses (Schänzer, 1996)[6]. Moreover, oxandrolone has shown minimal virilizing side effects, making it an appropriate choice for pediatric and female patients (Sheffield-Moore, et al., 2011)[7].

While I understand the FDA's responsibility is to safeguard public health, it's essential to thoroughly examine the balance between benefits and risks in real-world clinical contexts. Considering the extensive body of research supporting the efficacy and safety of oxandrolone, I urge you to reconsider this decision. The decision to withdraw a drug from the market should not be taken lightly, especially when it has proven beneficial for many patients who rely on it for necessary treatment.

I appreciate your attention to this matter and look forward to your response.

Sincerely,

Nelson Vergel
Founder, Program for Wellness Restoration
A 501 (c) 3 Organization

References:
[1] Grunfeld, C., et al. (2006). Oxandrolone in the treatment of HIV-associated weight loss in men: a randomized, double-blind, placebo-controlled study. Journal of Acquired Immune Deficiency Syndromes, 41(3), p.304-314.
[2] Goldberg, A. L., et al. (1996). Effects of Oxandrolone on Protein Metabolism in Burned Children. Nutrition in Clinical Practice, 11(1), p. 29-35.
[3] Jeschke, M. G., et al. (2005). The effect of oxandrolone on the endocrinologic, inflammatory, and hypermetabolic responses during the acute phase postburn. Ann Surg. 242(3): p. 384-91.
[4] Bonaiuti, D., et al. (2002). Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. (3): CD000333.
[5] Menke LA, Sas TC. (2010). The effect of oxandrolone on body proportions and body composition in growth hormone-treated girls with Turner syndrome. Clin Endocrinol (Oxf). 73(2): p. 212-9.
[6] Schänzer, W. (1996). Metabolism of anabolic androgenic steroids. Clin Chem. 42(7): p. 1001-20.
[7] Sheffield-Moore, M., et al. (2011). Short-term oxandrolone administration stimulates net muscle protein synthesis in young men. Journal of Clinical Endocrinology & Metabolism, 86(8), p. 3485-3491.

 

[tareload]

Any thoughts, comments, or edits? Planning to send this letter.

Alexandria Fujisaki
Regulatory Counsel, CDER
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States

Dear Ms. Fujisaki,

I am writing to express deep concern over the recent decision to notify oxandrolone manufacturers that the FDA believes the potential risks associated with this drug are severe enough to warrant its removal from the market. As an informed citizen, I would like to present a case that highlights the important positive and safe uses of oxandrolone for various medical conditions.

Oxandrolone, a synthetic derivative of testosterone, has been used effectively to promote weight gain in patients experiencing HIV wasting syndrome. Several studies, such as that by Grunfeld et al. (2006)[1], have demonstrated that oxandrolone, along with adequate nutrition, significantly increases body cell mass and muscle size in these patients with no hepatotoxicity.

Furthermore, this medication has been safely used to counteract protein catabolism caused by long-term corticosteroid therapy (Goldberg, et al., 1996)[2]. It's also proven to be effective in supporting recovery from severe burns, greatly improving lean body mass, bone mineral content, and muscle strength (Jeschke, et al., 2005)[3].

Notably, oxandrolone is used for the treatment of bone pain related to osteoporosis, enhancing both bone density and quality of life in patients (Bonaiuti, et al., 2002)[4]. It also plays a significant role in the development of girls with Turner syndrome, boosting height velocity and adult height (Menke & Sas, 2010)[5].

Safety and side effect profiles are important considerations for any medication, and it is crucial to remember that oxandrolone has been found to have a favorable safety profile. Studies have demonstrated no liver toxicity when used at clinically effective doses (Schänzer, 1996)[6]. Moreover, oxandrolone has shown minimal virilizing side effects, making it an appropriate choice for pediatric and female patients (Sheffield-Moore, et al., 2011)[7].

While I understand the FDA's responsibility is to safeguard public health, it's essential to thoroughly examine the balance between benefits and risks in real-world clinical contexts. Considering the extensive body of research supporting the efficacy and safety of oxandrolone, I urge you to reconsider this decision. The decision to withdraw a drug from the market should not be taken lightly, especially when it has proven beneficial for many patients who rely on it for necessary treatment.

I appreciate your attention to this matter and look forward to your response.

Sincerely,

Nelson Vergel
Founder, Program for Wellness Restoration
A 501 (c) 3 Organization

References:
[1] Grunfeld, C., et al. (2006). Oxandrolone in the treatment of HIV-associated weight loss in men: a randomized, double-blind, placebo-controlled study. Journal of Acquired Immune Deficiency Syndromes, 41(3), p.304-314.
[2] Goldberg, A. L., et al. (1996). Effects of Oxandrolone on Protein Metabolism in Burned Children. Nutrition in Clinical Practice, 11(1), p. 29-35.
[3] Jeschke, M. G., et al. (2005). The effect of oxandrolone on the endocrinologic, inflammatory, and hypermetabolic responses during the acute phase postburn. Ann Surg. 242(3): p. 384-91.
[4] Bonaiuti, D., et al. (2002). Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. (3): CD000333.
[5] Menke LA, Sas TC. (2010). The effect of oxandrolone on body proportions and body composition in growth hormone-treated girls with Turner syndrome. Clin Endocrinol (Oxf). 73(2): p. 212-9.
[6] Schänzer, W. (1996). Metabolism of anabolic androgenic steroids. Clin Chem. 42(7): p. 1001-20.
[7] Sheffield-Moore, M., et al. (2011). Short-term oxandrolone administration stimulates net muscle protein synthesis in young men. Journal of Clinical Endocrinology & Metabolism, 86(8), p. 3485-3491.

FDA approved, discontinued androgens (FDA orange book)

FDA has just approved norgestrel (progestin) for OTC but all Pharma versions of oxandrolone have been discontinued. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information Ignorance sure must be bliss.

www.excelmale.com

 

[Wilson7]

Political IMO. If it weren't a drug that is abused for cosmetic reasons, they would leave it alone. Unfortunate for those that could benefit from it clinically (cachexia, sarcopenia, recovery from surgery esp involving skeletal muscle and injury, etc.). Regardless, it just forces more people into the underground marketplace where oxandrolone is readily available and that simply increases the risks. I have not seen one study or case report that has shown serious liver issues with oxandrolone alone in dosing 20 mg/d or less in any population. Many drugs increase ALT/AST, while it should be followed, that doesn't necessarily mean that significant liver damage is occurring. I have a client on Gilenya for MS, ALT/AST in the low 100's for years, no evidence of liver dysfunction, scans normal. Even her doc admits that despite a large number of patients showing elevated LFTs on Gilenya, they are all doing fine. That doesn't mean everyone will do fine, just have to leave the drama out and stick with the facts.

 

[tareload]

My posts have an interesting habit of disappearing. Must be my humor? The last one was actually serious.

If there is any feedback on what I should not say let me know so I save my time in the future.

 

[Nelson Vergel]

The last one was too sarcastic and did not help the discussion. I enjoy your smarts but sometimes some of you get too cocky for my taste (I am ExcelMale's dictator LOL)

 

[tareload]

The last one was too sarcastic and did not help the discussion. I enjoy your smarts but sometimes some of you get too cocky for my taste (I am ExcelMale's dictator LOL)

Well if it came from you then I will have to take it! Thanks for the reply.

LOL.

Edit: I find humor to be helpful in dealing with many of situations we find today. I realize you wrote "some of you": however, I can only assure you it is not my intent to be cocky on here. I try to hold myself to highest standard of presenting scientifically accurate info and analysis. I of course defer to your wishes as this is your site and will turn down the volume my poor humor.

Thanks for the feedback.

 

[Charliebizz]

Can anyone tell me oxandrolone effects on cortisol in layman’s terms. I recently did a short trial. Admittedly it was ugl and not sure if it’s actually oxandrolone. But it really effected my performance at hockey. And overall I haven’t felt great. I have dr prescribed oxandrolone coming next week but now I’m kind of afraid to take it.

 

[Nelson Vergel]

Affected how ?

 

[Charliebizz]

Affected how ?

I just felt a lot of burning in my quads. And was getting gassed very quickly. more than usual.

 

[Nelson Vergel]

Did you take it with or without TRT?
Oxandrolone crashed my estradiol. Estradiol is important for tendon health. I used to aches more often on it.