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U.S. Consumer Group Wants Warning Label on Testosterone Drugs

Update Date: Feb 26, 2014 11:57 AM EST

Testosterone drugs are prescribed to treat low levels of testosterone, which can lead to depression, poor libido and a reduction in muscle mass. Based on studies, these drugs have been tied to increasing people's risk of suffering a heart attack or developing other cardiovascular problems. Due to these risks, a United States' consumer advocacy group, Public Citizen wants testosterone drugs to include a black box label informing patients about the heart risks involved with taking the drug.

Public Citizen had already petitioned the U.S. Food and Drug Administration (FDA) for the black box warning, which is the most serious type of label that the FDA could use. According to the researchers with this group, several studies have repeatedly found more evidence regarding the cardiac risks of taking testosterone drugs.

The group stated that a recent examination of 27 studies that date as far back as two decades ago indicated cardiac dangers. 14 of the 27 studies, which were not funded by the pharmaceutical industry, revealed a "highly significant" increased risk of cardiac complications. The remaining 13 did not find a risk and were all funded by the pharmaceutical industry.

The FDA has reported that based on the agency's previous investigation into the risk of stroke, heart attack and death related to testosterone drugs, it could not conclude that the drugs raise heart risks.

"In reaching this decision, FDA took into account the consistency of the findings across studies, as well as the quality of the existing data sources," FDA spokeswoman, Andrea Fischer, said according to Reuters Health. "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."

"It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks," the senior adviser at Public Citizen, Dr. Sidney Wolfe, stated and added that the FDA's statement was "a betrayal of the FDA's role as an agency in the U.S. Public Health Service."

Aside from the black box warning label, the advocacy group also asked the FDA to delay its decision making process for a long-acting testosterone product produced by Endo Health Solutions Inc. The item, Aveed, has already been rejected by the FDA twice before.

The FDA stated that it will review the recent petition.

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