Consumer advocacy group Public Citizen is petitioning the Food and Drug Administration (FDA) to require manufacturers of testosterone treatments to add black box warnings on the labels about the increased risk of heart attacks, stroke and death in men who use the treatment.
Black box warnings are the strongest given by drug regulators and signify that medical studies indicate that a particular drug carries a significant risk of serious or even life-threatening adverse events.
Testosterone supplements, including AndroGel, Testim and Axiron, are approved by the FDA to treat hypogonadism, a medical condition in which the testes produce little to no testosterone. It can result in symptoms such as low sex drive, a decrease in muscle mass, weight gain, and fatigue.
Heavy marketing campaigns launched by makers of testosterone products have encouraged men to talk with their doctors to see if they may have “Low T,” which has led to skyrocketing sales of the drugs. Many critics worry that a lot of men prescribed the treatment may not need it.
Little was known about the long-term effects of testosterone, however recent studies and new analyses revealed that the drugs can actually increase the risk of cardiovascular events. Older men who used the supplements increased their heart risk by a third while men with heart disease who used the drugs nearly doubled their risk.
The studies have prompted the FDA to launch an investigation into the safety of testosterone treatment. The agency said it will report its findings and any recommendations once its investigation is complete.
Public Citizen is also urging the FDA to delay its decision on a new long-acting testosterone drug made by Endo Heath Solutions called Aveed. The drug has been rejected by the FDA two previous times because of injection-site reactions and concerns about blockages in blood vessels in the lungs.
Source: Chicago Tribune