FDA Low T Warning

Serious concerns about the possible increased risk of heart attacks and strokes in patients using “low-T” products, have led the Food and Drug Administration to issue a new ruling requiring the makers of these dugs to alter labeling to reflect the dangers associated with them.

The FDA will now require the makers of “low-T” products, to make clear that using these products carries the possible increased risk of heart attacks and strokes. The new labeling will also state that these drugs are only approved to treat low testosterone levels caused by disease or injury, not normal aging.

What shocks me most is that it has taken the FDA so long to act, especially since evidence of the dangers of taking “low-T” drugs has been mounting for years. For over a year the Public Citizen Health Research Group, a public-interest entity has called for the FDA to issue this warning, and last July the Canadian government issued a warning about cardiovascular risks of testosterone products. These actions came after a comprehensive study was released last February in the medical journal PLoS One. That study found that taking testosterone replacement drugs caused dangerous health problems. Within three months, taking the hormone doubled the rate of heart attacks in men 65 and older, as well as in younger men who had heart disease. The findings in the PLoS One study were similar to another study released in 2010, yet neither study could get the FDA to act. Their reluctance might stem from the pressure from the pharmaceutical companies who have created a billion dollar market for these drugs and see any kind of warning as a threat to their bottom line.

The makers of such popular “low-T” drugs like AndroGel or Axiron have manufactured a cure and then used the media and aggressive marketing to sell drugs to patients who take them– not to treat any genuine medical conditions – but as a lifestyle choice.

Millions of American men are risking their health and resorting to testosterone drugs out of simple reluctance to accept the fact that they are getting older. By issuing these latest warnings the FDA seems to be admitting to the dangers posed by “low-t” drugs. When will the pharmaceutical companies who make these dangerous drugs do the same?