ExcelMale
Menu
Home
What's new
Latest activity
Forums
New posts
Search forums
What's new
New posts
Latest activity
Videos
Lab Tests
Doctor Finder
Buy Books
About Us
Men’s Health Coaching
Log in
Register
What's new
Search
Search
Search titles only
By:
New posts
Search forums
Menu
Log in
Register
Navigation
Install the app
Install
More options
Contact us
Close Menu
Forums
Clinical Use of Anabolics and Hormones
Clinical Use of Anabolics and Hormones
FDA Removed Oxandrin (oxandrolone) tablets from the list of drug products published in the Orange Book
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an
alternative browser
.
Reply to thread
Message
<blockquote data-quote="Nelson Vergel" data-source="post: 274402" data-attributes="member: 3"><p>Alexandria Fujisaki</p><p>Regulatory Counsel, CDER</p><p>Food and Drug Administration</p><p>10903 New Hampshire Avenue</p><p>Silver Spring, MD 20993</p><p>United States</p><p></p><p>Dear Ms. Fujisaki,</p><p></p><p>I am writing to express deep concern over the recent decision to <a href="https://www.federalregister.gov/documents/2023/06/28/2023-13733/gemini-laboratories-llc-et-al-withdrawal-of-approval-of-one-new-drug-application-for-oxandrin" target="_blank">notify oxandrolone manufacturers</a> 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 and long-term HIV advocate, I would like to present a case that highlights the important positive and safe uses of oxandrolone for various medical conditions.</p><p></p><p>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.</p><p></p><p>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].</p><p></p><p>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].</p><p></p><p>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].</p><p></p><p>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.</p><p></p><p>I appreciate your attention to this matter and look forward to your response.</p><p></p><p>Sincerely,</p><p></p><p>Nelson Vergel</p><p>Founder, Program for Wellness Restoration</p><p>A 501 (c) 3 Organization</p><p></p><p>References:</p><p>[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.</p><p>[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.</p><p>[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.</p><p>[4] Bonaiuti, D., et al. (2002). Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. (3): CD000333.</p><p>[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.</p><p>[6] Schänzer, W. (1996). Metabolism of anabolic androgenic steroids. Clin Chem. 42(7): p. 1001-20.</p><p>[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.</p><p></p><p></p><p>All the best,</p><p></p><p>Nelson Vergel, BsChE, MBA</p><p>Founder</p><p><a href="https://powerusa.org/" target="_blank">Program for Wellness Restoration</a></p><p>A 501 (c) 3 Non-Profit Organization</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 274402, member: 3"] 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 [URL='https://www.federalregister.gov/documents/2023/06/28/2023-13733/gemini-laboratories-llc-et-al-withdrawal-of-approval-of-one-new-drug-application-for-oxandrin']notify oxandrolone manufacturers[/URL] 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 and long-term HIV advocate, 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. All the best, Nelson Vergel, BsChE, MBA Founder [URL='https://powerusa.org/']Program for Wellness Restoration[/URL] A 501 (c) 3 Non-Profit Organization [I][/I] [/QUOTE]
Insert quotes…
Verification
Post reply
Share this page
Facebook
Twitter
Reddit
Pinterest
Tumblr
WhatsApp
Email
Share
Link
Sponsors
Forums
Clinical Use of Anabolics and Hormones
Clinical Use of Anabolics and Hormones
FDA Removed Oxandrin (oxandrolone) tablets from the list of drug products published in the Orange Book
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to our use of cookies.
Accept
Learn more…
Top