FDA Investigating Risks of Testosterone Therapy

FDA Investigating Risks of Testosterone Therapy

February 3rd, 2014 // 1:56 pm @

FDA announced at the end of last week that it is going to investigate risks of heart disease and death that may be caused in some cases by testosterone therapy. This is a move by FDA that is being prompted by two clinical studies that have raised some questions about the health risks of using the hormone.

FDA stated that it has been monitoring some of the potential risks and has decided to move ahead with its investigation after the studies indicated that there is a higher risk of heart attack, stroke, and death among men who have been taking testosterone.

According to one study that was published in JAMA in 2013, US vets who took the drug had higher risks of heart attack, stroke and death.

Another study that was reported last week in PLOS One, noted there is a higher risk of heart attack in older males, but also in younger males who had heart disease already – if those people had filled an RX for testosterone.

FDA did not state when its review is going to be finished, but FDA did state that patients should not stop taking their drugs. They should speak with their doctors if they have any concerns.

FDA stated that testosterone products are only approved by FDA for use in men who have documented lower testosterone levels related to another medical condition. Some of the conditions that testosterone should be prescribed for include when the testicles fail to produce enough of the hormone, or issues with genetics or chemo treatments. Other problems that could call for testosterone therapy include problems with the hypothalamus or the pituitary gland.

But FDA noted that these hormone treatments are often being promoted for non-medically valid reasons, including being tired after dinner or lower sex drive.

FDA stressed that FDA approved testosterone products are not approved for men with lower testosterone levels who do not have a related medical condition causing this issue.


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