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Testosterone Products should warn of cardiac risk? (2014-02-26)

Drugs used to treat low testosterone should carry strong warnings about the risk of heart attacks and other cardiovascular problems, the consumer advocacy group Public Citizen said on Tuesday.

Public Citizen called on the U.S. Food and Drug Administration (FDA) to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.



he urgent petition is based on growing evidence of the risks of heart attacks and other cardiovascular dangers from many individual randomized studies going back as far as 2010 and a recently published overall analysis (meta-analysis) of 27 studies going back as far as 20 years.
Although 13 of these studies, funded by the drug industry, collectively showed no increased risk, the 14 studies not funded by the industry collectively showed a highly significant increased cardiovascular risk.

More than five million U.S. prescriptions for testosterone products were filled in 2013. The most common of those, making up more than 90 percent of the testosterone prescriptions filled in 2013, include Androgel, Axiron, Testim and Fortesta.

The petition also was prompted by the most recent study, involving the experience of 55,000 men before and after starting testosterone.
The risk of heart attacks among men 65 and older during the first three months of using the drug was twice the risk seen in the year before use.
Further, the study found, for the first time, a 2.9-fold increase in heart attack risk among men under 65 with a history of heart disease who took testosterone.

Testosterone therapy is approved by the FDA for men who lack or have low testosterone in conjunction with an associated medical condition, such as a genetic failure of the testicles to produce testosterone. Symptoms can include loss of libido, depression, decreased muscle mass and fatigue.

According to Public Citizen, almost 25 percent of men prescribed testosterone did not previously have a blood test to determine if their level was low.

FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. FDA have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.

See also
Testosterone Products: Drug Safety FDA Communication (2014-02-01)

For more information
Public Citizen Petitions FDA for a Black Box Warning on Testosterone Products

FDA - U.S. Food and Drug Administration
Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events