FDA approved, discontinued androgens (FDA orange book)

[tareload]

FDA has just approved norgestrel (progestin) for OTC but all Pharma versions of oxandrolone have been discontinued.

Learn more about Opill (0.075mg Oral Norgestrel Tablet)

This page gives consumers important safety information and answers important questions about nonprescription birth control, Opill (0.075 Oral Norgestral Tablet)

www.fda.gov

Ignorance sure must be bliss.

 

[Nelson Vergel]

I am so happy women now have an OTC option!

The picture about oxandrolone is not completely clear. All US manufacturers have stopped making it. The FDA information is erroneous since it mentions hepatotoxicity. We know oxymetholone definitely has caused that issue when people use it for long periods of time. But oxandrolone has not shown that type of safety signal.

From ChatGPT:


Oxymetholone and Oxandrolone are both oral anabolic steroids. They are C-17 alpha-alkylated, a structural alteration that allows them to survive oral ingestion by bypassing the liver and entering the bloodstream. Both substances are known to exert their effects on muscle tissue, leading to increased muscle mass. However, they also have distinct effects on the liver that are important to consider.

1. Oxymetholone

Oxymetholone, sold under the brand names Anadrol and Anapolon among others, is an androgen and anabolic steroid (AAS) medication primarily used to treat anemia. It is also used to treat osteoporosis, HIV/AIDS wasting syndrome, and to promote weight gain and muscle growth in certain situations.

Due to its potent anabolic effects, Oxymetholone is commonly used illicitly by bodybuilders and athletes. However, it has several hepatic side effects that are of concern. The most notable of these is hepatotoxicity.

Oxymetholone can cause liver damage, which is usually reversible after discontinuation of the drug. Clinical studies have reported a strong association between oxymetholone usage and the development of liver abnormalities such as peliosis hepatis (blood-filled cavities in the liver), cholestasis (reduction or stoppage of bile flow), and liver tumors, including hepatocellular carcinoma (Alhadad A., 2019).

One case-control study demonstrated the incidence of hepatic tumors in bodybuilders who abused anabolic steroids, including oxymetholone (Socas L., 2005). The nature of these tumors varied from benign adenomas to hepatocellular carcinoma.

Reference:

Alhadad A. A., 2019. Acute kidney injury and cardiomyopathy due to oxymetholone abuse. Case reports in nephrology, 2019.

Socas L., 2005. Hepatocellular adenomas associated with anabolic androgenic steroid abuse in bodybuilders: a report of two cases and a review of the literature. British journal of sports medicine, 39(5), pp.e27.


2. Oxandrolone

Oxandrolone, sold under the brand names Oxandrin and Anavar, among others, is an androgen and anabolic steroid (AAS) medication which is used to help promote weight gain in various situations, to help offset protein catabolism caused by long-term corticosteroid therapy, to support recovery from severe burns, to treat bone pain associated with osteoporosis, and to aid in the development of girls with Turner syndrome.

Compared to oxymetholone, oxandrolone has a more favorable safety profile. It is less hepatotoxic and is less likely to promote virilization (development of male physical characteristics) in women.

Although oxandrolone is classified as a Schedule III controlled substance due to potential for misuse and abuse, it does not appear to have the same level of hepatotoxicity as oxymetholone. Most studies on oxandrolone have demonstrated mild, transient elevations in liver enzymes, but these generally return to normal upon discontinuation of the drug. There are very few case reports of serious hepatic side effects from oxandrolone, and those that do exist often involve other complicating factors such long term use and higher doses (Demling RH., 1999).

However, it's important to remember that "less hepatotoxic" does not mean "non-hepatotoxic." Any long term usage of oral anabolic steroids should be done under the supervision of a healthcare provider, who can monitor liver function and adjust dosages as necessary.

Reference:

Demling RH., 1999. Oxandrolone, an anabolic steroid, enhances the healing of a cutaneous wound in the rat. Wound Repair and Regeneration, 7(2), pp.97-102.

To conclude, both Oxymetholone and Oxandrolone have potential hepatotoxic effects due to their C-17 alpha-alkylated nature. Oxymetholone is associated with a higher risk of serious liver damage, including cholestasis and hepatocellular carcinoma. On the other hand, Oxandrolone seems to have a more favorable safety profile and is associated with mild and usually reversible liver enzyme elevations. However, both should be used under medical supervision, as misuse and overuse can lead to severe hepatic injury.

 

[tareload]

See here:

Approved Drug Products with Therapeutic Equivalence Evaluations (Orang

Approved Drug Products with Therapeutic Equivalence Evaluations identifies drug products approved on the basis of safety and effectiveness

www.fda.gov

nandrolone
ethyloestrenol - maxibolin
dromostanolone - masteron
fluoxymesterone - halotestin
oxandrolone
stanozolol
oxymetholone

are all FDA approved discontinued medications. This includes NPP.

Any I missed? Let me know.

For those paying attention only a few of these are available through compounding pharmacies in US. Why? Lack of USP supply? Too risky?

@Jason Sypolt or Shaun Noorian @EmpowerPharmacy want to weigh in on this? Might as well have an accurate list all in one place.

Love to hear opinion of compounding association counsel on future availability.

Professor Hulk Cycle Log

I am sorry you had to experience that. Are you in the US or is this Costa Rica? This is a “TRT clinic” with a physical address or a table set up with a tablecloth at a local weight training facility? Genuinely interested. @unreal24278 FYI, “primobolan aka Metenolone” and “trenbolone aka...

forums.t-nation.com

 

[Nelson Vergel]

Nandrolone was discontinued a long time ago for issues NOT related to safety.

The End of Nandrolone

On March 20, 2007, Watson Laboratories stopped the production of nandrolone decanoate (old brand name: Deca Durabolin), a low-cost injectable anabolic steroid used for HIV wasting, citing the lack of

www.thebody.com

 

[tareload]

Nandrolone was discontinued a long time ago for issues NOT related to safety.

The End of Nandrolone

On March 20, 2007, Watson Laboratories stopped the production of nandrolone decanoate (old brand name: Deca Durabolin), a low-cost injectable anabolic steroid used for HIV wasting, citing the lack of

www.thebody.com

Yes I shared the FDA letter in other thread.

Federal Register :: Request Access

 

[BigTex]

See here:

Approved Drug Products with Therapeutic Equivalence Evaluations (Orang

Approved Drug Products with Therapeutic Equivalence Evaluations identifies drug products approved on the basis of safety and effectiveness

www.fda.gov

nandrolone
ethyloestrenol - maxibolin
dromostanolone - masteron
fluoxymesterone - halotestin
oxandrolone
stanozolol
oxymetholone

are all FDA approved discontinued medications. This includes NPP.

Any I missed? Let me know.

For those paying attention only a few of these are available through compounding pharmacies in US. Why? Lack of USP supply? Too risky?

@Jason Sypolt or Shaun Noorian @EmpowerPharmacy want to weigh in on this? Might as well have an accurate list all in one place.

Love to hear opinion of compounding association counsel on future availability.

Professor Hulk Cycle Log

You’re absolutely right. I can’t definitively say that it’s not primo unless I ship it off somewhere for testing. I’m basing my assertion on: The fact that it came from a lab, not a pharmacy The fact that there was a knock-off name on the label, not Primobolan. The fact that I immediately...

forums.t-nation.com

Haha....I got that TNation link to open this time! I use to liike fluoxymesterone.

 

[BigTex]

Nandrolone was discontinued a long time ago for issues NOT related to safety.

The End of Nandrolone

On March 20, 2007, Watson Laboratories stopped the production of nandrolone decanoate (old brand name: Deca Durabolin), a low-cost injectable anabolic steroid used for HIV wasting, citing the lack of

www.thebody.com

Nelson, I have to wonder how Watson could cry "the lack of raw-material suppliers" When I could give him 4 suppliers right now that are capable of supplying metric tons? Seems like there had to be another reason to stop production that they are not telling us. My bet is the DEA gave a hand in this decision.

 

[Nelson Vergel]

After FDA notified Gemini that it believes the potential problems associated with the drug are sufficiently serious that the drug should be removed from the market pursuant to § 314.150(d), Gemini requested in a letter dated December 19, 2022 that FDA withdraw approval of NDA 013718 under §  314.150(d). Gemini waived its opportunity for a hearing. In a letter dated December 23, 2022, Sandoz requested that FDA withdraw approval of ANDA 076897 under §  314.150(d). Sandoz waived its opportunity for a hearing. In a letter dated January 5, 2023, Par requested that FDA withdraw approval of ANDA 077827 under §  314.150(d). Par waived its opportunity for a hearing. In separate letters dated January 6, 2023, Upsher-Smith requested that FDA withdraw approval of ANDAs 078033 and 076761 under §  314.150(d). Upsher-Smith waived its opportunity for a hearing.

Federal Register :: Request Access

 

[Nelson Vergel]

Any thought, 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]

I guess the question is how much you want to throw the books at these people without turning them off?

Happy to weave in all the references I shared in the other thread plus this good one:

Winning the war against ICU-acquired weakness: new innovations in nutrition and exercise physiology

Over the last 10 years we have significantly reduced hospital mortality from sepsis and critical illness. However, the evidence reveals that over the same period we have tripled the number of patients being sent to rehabilitation settings. Further, given ...

www.ncbi.nlm.nih.gov

Just let me know if that is compatible with your vision.


As of now, the letter shared by FDA needs retraction and correction. It is a completely misleading and incomplete piece of scholarship.

 

[tareload]

808: RETROSPECTIVE REVIEW OF OXANDROLONE FOR HEAD AND NECK... : Critical Care Medicine

An abstract is unavailable.

journals.lww.com

 

[tareload]

Acute Pediatric Burn Management

Thermal injuries are among the most common and devastating injuries in armed conflicts and are a leading cause of death and disability among children. Managing these wounds requires intensive therapeutic and surgical treatments to reduce the acute and chronic...

link.springer.com

 

[tareload]

Incidence of oxandrolone induced hepatic transaminitis in patients with burn injury

The benefits of oxandrolone in burn patients has led to its accepted use in the burn care community, however details regarding the most common adverse…

www.sciencedirect.com

 

[tareload]

Oxandrolone protects against the development of multiorgan failure, modulates the systemic inflammatory response and promotes wound healing during burn injury

Oxandrolone is a synthetic oral non-aromatizable testosterone derivative. This drug has been used successfully for several decades to safely treat gro…

www.sciencedirect.com

 

[tareload]

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

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. Oxandrolone ...

www.ncbi.nlm.nih.gov

 

[tareload]

See here:

Approved Drug Products with Therapeutic Equivalence Evaluations (Orang

Approved Drug Products with Therapeutic Equivalence Evaluations identifies drug products approved on the basis of safety and effectiveness

www.fda.gov

nandrolone
ethyloestrenol - maxibolin
dromostanolone - masteron
fluoxymesterone - halotestin
oxandrolone
stanozolol
oxymetholone

are all FDA approved discontinued medications. This includes NPP.

Any I missed? Let me know.

For those paying attention only a few of these are available through compounding pharmacies in US. Why? Lack of USP supply? Too risky?

@Jason Sypolt or Shaun Noorian @EmpowerPharmacy want to weigh in on this? Might as well have an accurate list all in one place.

Love to hear opinion of compounding association counsel on future availability.

Professor Hulk Cycle Log

I am sorry you had to experience that. Are you in the US or is this Costa Rica? This is a “TRT clinic” with a physical address or a table set up with a tablecloth at a local weight training facility? Genuinely interested. @unreal24278 FYI, “primobolan aka Metenolone” and “trenbolone aka...

forums.t-nation.com

Wow, not even one comment on this?

 

[Nelson Vergel]

Comments are public and can be used against people who comment. That is an issue when usernames are actual people's names (like my own or others).

 

[tareload]

Comments are public and can be used against people who comment. That is an issue when usernames are actual people's names (like my own or others).

Good point. Hence I am private. Kinda confirms my reasoning. Thank you Nelson for your honesty.

You are a good boss I will continue to work hard for. Smile.

 

[tareload]

1. nandrolone
2. ethyloestrenol - maxibolin
3. dromostanolone - masteron
4. fluoxymesterone - halotestin
5. oxandrolone
6. stanozolol
7. oxymetholone

@BigTex would USP suppliers be limiting any of these from a compounder's POV?

Obviously not an issue for 1, 5, 6. I have heard of 7 being available. No idea for 2, 3, 4.

If any of these go on the FDA difficult to compound class 2 list then game over I take it.

I hope you are feeling better although from my experience the first few days are rough. Did they give you anything?

 

[SteveCleves]

I am pretty sure I came across a Bro-trt clinic that offered compounded fluoxymesterone.