Testosterone Products and Cardiovascular Safety National Pbm Bulletin Department of Veterans Affairs Veterans Health Administration (Vha) Pharmacy Benefits Management Services (Pbm), Medical Advisory Panel (Map), and Center for Medication Safety (Va Medsa

  • (VHA)
  • ADMINISTRATION D
  • (PBM) P
  • et al.
ISSN: 1932-6203
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Abstract

I. ISSUE Two recent studies identify a possible risk of increased cardiovascular events in men receiving testosterone therapy. FDA continues to evaluate this association between testosterone treatment and increased risk of stroke, heart attack, or death, but has not yet reached a firm conclusion. 1 II. BACKGROUND Testosterone use is indicated for men with testosterone deficiency associated with a medical condition, such as genetic problems, chemotherapy, or other biochemical disorders affecting the production of testosterone by the testicles. Low testosterone levels in the absence of a medical condition are not an approved indication for testosterone products. FDA-approved testosterone formulations consist of a topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. III. DISCUSSION Two publications have prompted FDA to reassess the cardiovascular safety of testosterone therapy. One observational study looking at elderly men in the U.S. Veteran Affairs health system who underwent coronary angiography to assess for coronary artery disease and had a low serum testosterone suggested a 30 percent increase in risk for stroke, heart attack, and death in the group that received testosterone therapy compared to the group that did not receive any testosterone therapy. Many of these patients had underlying cardiovascular disease. 2 Another observational study reported an increased risk of heart attack in older men (two-fold increase in the risk of heart attack among men aged 65 years and older within 90 days after initial prescription), as well as in younger men with pre-existing heart disease (a two-to three-fold increase in the risk of heart attack within 90 days after initial prescription). Younger men with no history of heart disease who received a prescription for testosterone did not demonstrate an increased risk of heart attack.

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APA

(VHA), ADMINISTRATION, D. O. V. A. V. H., (PBM), P. B. M. S., & MEDICAL ADVISORY PANEL (MAP), A. C. F. M. S. (VA M. (2014). Testosterone Products and Cardiovascular Safety National Pbm Bulletin Department of Veterans Affairs Veterans Health Administration (Vha) Pharmacy Benefits Management Services (Pbm), Medical Advisory Panel (Map), and Center for Medication Safety (Va Medsa. PLoS ONE, 9(1), e85805. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/24489673%0Ahttp://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=PMC3905977%0Ahttp://dx.plos.org/10.1371/journal.pone.0085805%0Ahttps://www.pbm.va.gov/PBM/vacenterformedicationsafety/nationalpbmbulletin/Testosterone_

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