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Expert Interviews
Can Testosterone Induce Blood Clots and Thrombosis? Interview with Dr Charles Glueck
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<blockquote data-quote="Nelson Vergel" data-source="post: 248803" data-attributes="member: 3"><p>According to the provided web search results, the FDA has issued multiple black box warnings for testosterone products. Here are the details on when each warning was added:</p><p></p><ol> <li data-xf-list-type="ol">Cardiovascular Risk: The FDA issued a safety communication about the cardiovascular risk associated with testosterone products on March 3, 2015. [<a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-cautions-about-using-testosterone-products-low-testosterone-due" target="_blank">1</a>]</li> <li data-xf-list-type="ol">Abuse and Dependence: The FDA approved class-wide labeling changes for all prescription testosterone products, adding a new warning and updating the abuse and dependence information on October 25, 2016. [<a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-changes-testosterone-labeling-regarding-risks-associated-abuse-and-dependence" target="_blank">2</a>]</li> <li data-xf-list-type="ol">Prostate Cancer: None of the provided search results mentioned a black box warning specifically related to prostate cancer for testosterone products.</li> <li data-xf-list-type="ol">Blood Clots: In response to studies showing the risk of blood clots, stroke, heart attack, and death associated with testosterone therapy, Public Citizen filed a petition to the FDA on <strong>February 25, 2014</strong>, demanding the agency immediately require a black-box warning for cardiovascular risks on all testosterone therapy drugs. However, it is not clear from the provided search results whether the FDA ever issued a black box warning specifically related to blood clots for testosterone products. [<a href="https://www.ajmc.com/view/fda-safety-warnings-and-trends-in-testosterone-marketing-to-physicians" target="_blank">3</a>, <a href="https://www.drugwatch.com/podcast/doctor-urges-fda-warning-testosterone/" target="_blank">4</a>]</li> <li data-xf-list-type="ol">Children's Risk: The FDA ordered a black box warning for the risk that testosterone gel products pose to children inadvertently exposed to those products by adults on May 7, 2009. [<a href="https://www.webmd.com/men/news/20090507/testosterone-gels-risky-to-children" target="_blank">5</a>]</li> </ol></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 248803, member: 3"] According to the provided web search results, the FDA has issued multiple black box warnings for testosterone products. Here are the details on when each warning was added: [LIST=1] [*]Cardiovascular Risk: The FDA issued a safety communication about the cardiovascular risk associated with testosterone products on March 3, 2015. [[URL='https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-cautions-about-using-testosterone-products-low-testosterone-due']1[/URL]] [*]Abuse and Dependence: The FDA approved class-wide labeling changes for all prescription testosterone products, adding a new warning and updating the abuse and dependence information on October 25, 2016. [[URL='https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-changes-testosterone-labeling-regarding-risks-associated-abuse-and-dependence']2[/URL]] [*]Prostate Cancer: None of the provided search results mentioned a black box warning specifically related to prostate cancer for testosterone products. [*]Blood Clots: In response to studies showing the risk of blood clots, stroke, heart attack, and death associated with testosterone therapy, Public Citizen filed a petition to the FDA on [B]February 25, 2014[/B], demanding the agency immediately require a black-box warning for cardiovascular risks on all testosterone therapy drugs. However, it is not clear from the provided search results whether the FDA ever issued a black box warning specifically related to blood clots for testosterone products. [[URL='https://www.ajmc.com/view/fda-safety-warnings-and-trends-in-testosterone-marketing-to-physicians']3[/URL], [URL='https://www.drugwatch.com/podcast/doctor-urges-fda-warning-testosterone/']4[/URL]] [*]Children's Risk: The FDA ordered a black box warning for the risk that testosterone gel products pose to children inadvertently exposed to those products by adults on May 7, 2009. [[URL='https://www.webmd.com/men/news/20090507/testosterone-gels-risky-to-children']5[/URL]] [/LIST] [/QUOTE]
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Can Testosterone Induce Blood Clots and Thrombosis? Interview with Dr Charles Glueck
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