The consumer advocacy group Public Citizen is pushing for the Food and Drug Administration to add a warning label of heart attacks and other cardiovascular issues on testosterone drugs.
Public Citizen said the FDA should put a "black box" warning on all drugs used to treat testosterone, according to Associated Press. A black box warning is the most serious type of warning, and the advocacy group wants this warning to make consumers aware of high risks of heart attack, stroke and death when taking medication used for low testosterone.
The group has started a petition for the label based on increasing evidence of heart attacks and other cardiac problems, Reuters reported. The evidence includes studies that go back to 2010 and an analysis that was recently published, which includes 27 studies starting about 20 years ago.
The FDA announced last month that it was investigating the safety of testosterone drugs due to two recent studies which showed higher rates of cardiac issues in men, Associated Press reported. These drugs include the testosterone gel called AndroGel.
Dr. Sidney Wolfe, of Public Citizen's health group, talks about the 27 studies in the petition, according to Associated Press. Wolfe pointed out that while 13 studies funded by drug companies did not show an increase in heart issues, 14 non-industry funded trials show a doubled increase in cardiovascular risks.
"It's quiet clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks," Wolfe said.
In response to the FDA's statement that it had not concluded that testosterone drugs increase risk of heart problems, Wolfe said the FDA's statement was "reckless" and "a betrayal of the FDA's role as an agency in the U.S. Public Health Service," Reuters reported.
The FDA stated it is reviewing Public Citizen's petition, according to Reuters. FDA spokeswoman Andrea Fischer stated that the data in an earlier review of cardiac risks in testosterone drugs was "mixed and insufficient to support a regulatory action."
"In reaching this decision, FDA took into account the consistency of the finding across the studies, as well as the quality of the existing data sources," Fischer said. "FDA is unable to reach conclusions based on the current data until we have had the opportunity to review the strengths and weaknesses of the new studies and integrate the findings with all other available and appropriate data."
