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FDA Evaluating the Risk of Heart Attack, Stroke and Death Following Testosterone Therapy in Men

FDA Evaluating the Risk of Heart Attack, Stroke and Death Following Testosterone Therapy in Men

A recent safety announcement issued by the FDA warned of safety risks associated with testosterone therapy (TT). In particular, the "FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products."

Two recent publications have prompted the FDA "to reassess the cardiovascular safety" of TT. A November 2013 publication reported 29% increase in the combined risk of stroke, heart attack, and death in men who underwent TT. The risk was increased regardless of whether the men were suffering from coronary artery disease or not. Another publication from January 2014 found a two-fold increase in the risk of heart attack in men aged 65 years or older. Furthermore, the study observed two to three-fold increased risk in younger men (aged less than 65 years) who had a history of heart disease.

The FDA is continuing to evaluate information from these studies, as well as other available data, and will issue further announcements and recommendations upon completion of its assessment.

Sources:

FDA,

http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM383909.pdf

The Journal of the American Medical Association,

http://jama.jamanetwork.com/article.aspx?articleid=1764051

PLOS One, http://www.plosone.org/article/fetchObject.action?uri=info%3Adoi%2F10.1371%2Fjournal.pone.0085805&representation=PDF

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