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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
F.D.A. Panel Backs Limits on Testosterone Drugs but Rejects Petition for More Regulations
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<blockquote data-quote="Nelson Vergel" data-source="post: 15823" data-attributes="member: 3"><p>Troutman</p><p></p><p></p><p>Today's press release from the FDA contradicts the points they made in the letter I shared above. May be it is time to send them a letter. This sends the wrong message.</p><p></p><p></p><p><strong>FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use.</strong></p><p><strong><a href="http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm" target="_blank">http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm</a></strong></p><p></p><p></p><p>[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014. <a href="http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm" target="_blank">http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm</a> ]</p><p></p><p></p><p>The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.</p><p></p><p></p><p>The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone.</p><p></p><p></p><p>We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications.</p><p></p><p></p><p>We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone.</p><p></p><p></p><p>Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 15823, member: 3"] Troutman Today's press release from the FDA contradicts the points they made in the letter I shared above. May be it is time to send them a letter. This sends the wrong message. [B]FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use.[/B] [B][URL]http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm[/URL][/B] [This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014. [URL]http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm[/URL] ] The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man's symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
F.D.A. Panel Backs Limits on Testosterone Drugs but Rejects Petition for More Regulations
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