Media Advisory: UCLA Fielding School of Public Health Study prompts FDA investigation
The Food & Drug Administration (FDA) is investigating the risk of stroke, heart attack, & death in men taking FDA-approved testosterone products.
February 3, 2014
UCLA Fielding School of Public Health Study prompts FDA investigation
The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA decided to reassess this safety issue based on the recent publication of a UCLA-led study published last week in PLOS ONE, and a 2013 study published in the Journal of the American Medical Association (JAMA). The separate studies each suggested an increased risk of cardiovascular events, as did several small clinical trials.
The UCLA-led study observed a twofold increase in the risk of a heart attack shortly after beginning testosterone therapy among men under 65 who have a history of heart disease. Further, the study confirmed the results of earlier studies that found a twofold increase in heart attack risk shortly after treatment began in men older than 65.
Dr. Sander Greenland, the UCLA study's senior author, a professor of epidemiology at the UCLA Fielding School of Public Health, and a professor of statistics in the UCLA College of Letters and Science.
Greenland is available for print and radio media interviews.
Advertising for low testosterone levels has been so successful that, according to Drugs.com, an independent medicine website, sales of the testosterone gel Androgel has exceeded sales of Viagra since 2012.
Greenland and his colleagues examined the health care records of 55,593 men who had been prescribed testosterone therapy — 48,539 under the age of 65 and 7,054 who were 65 or older. Their research led to the finding of a twofold increase in men under 65 with heart disease and confirmed the earlier findings of a twofold increase in men over 65 with or without heart disease.