Two days after the US Food and Drug Administration announced that testosterone replacement products must now carry warning labels on the risks of heart attack and stroke, 2 researchers presented abstracts of studies indicating that there is no such danger. The studies were publicized by the American College of Cardiology and will be presented in detail at the group's upcoming meeting in San Diego, CA.
The US Food and Drug Administration (FDA) on March 3 ordered manufacturers of testosterone products to alter their labeling to include a warning about possible cardiac events.
But in 2 research papers to be presented at the upcoming American College of Cardiology meeting in San Diego, CA, doctors say they found no evidence of cardiovascular risk in testosterone therapy.
The FDA warning is aimed at physicians who prescribe such products for lowered hormone levels that are due to aging, rather than specific medical problems.
In announcing the new labeling requirement, the FDA said an advisory committee had reviewed existing studies and found evidence of an increase in adverse cardiac events and stroke, and that some men taking the supplements had died.
Today, reporting on a meta-analysis of data from 29 studies involving more than 120,000 men, Pawan Patel, MD, an academic physician at Regions Hospital in St. Paul, Minn. said he found no evidence in the literature he surveyed showing that testosterone caused an excess of cardiovascular events in men who took it.
In the Wisconsin study, Arshad Jahangir, MD, director of the Center for Integrative Research on Cardiovascular Health at the Aurora Health system, reported similar findings in 7,245 men who got testosterone .
Jahangir said the findings “will help ease anxieties around this treatment and provide some information on which physicians can base their prescribing decisions.”
Patel said his results also show that the debate over testosterone therapy will likely continue until there is a long-term, prospective randomized trial comparing outcomes in men who use testosterone and those who do not.
Both studies will be presented at the meeting on March 14.