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FDA Moves to Relabel of Testosterone

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Testosterone has long been a popular drug for a number of years. Obviously, in its organic state, testosterone is hugely important for both sexes, but especially males. Some men are born producing unnaturally low levels of the chemical. For them, prescription testosterone gives these patients a second chance at life. Now, though, the FDA has begun cautioning that the prescription version should only ever be prescribed to those who can’t make enough because of a genetic defect. They may even push to have the drug relabeled in order to stave off those who would take testosterone for other reasons.

Testosterone Replacement Theory

Testosterone is approved by the FDA as a form of replacement therapy in males who have been tested and proven to have low levels. There are a number of reasons men might not produce normal levels of testosterone naturally. They can include disorders of the:

  • Pituitary gland
  • Testicles
  • Brain

In the end, any of these disorders result in what’s called hypogonadism. Some men are born without any problems, but some kind of incident later on in life injures them in a way that they can no longer create testosterone like they once did.

For example, chemotherapy sometimes goes wrong and has this effect. Infection could also bring about this unfortunate result.

Low Testosterone as Men Age

That being said, no man is supposed to just keep on making testosterone for the rest of their lives. As men get older, their testosterone production begins to ramp down. Typically, this begins happening sometime after their mid-30s.

Despite the fact that this is what nature intended, many men aren’t ready to give up their testosterone so soon. This may drive them to seek out prescription testosterone, as a way to make up for what they’re naturally losing.

Some professional athletes have done this in order to keep their winning edge as they age. However, more commonly, men seek out prescription testosterone because it helps them stay young. This makes sense, of course. Young men in their teens and early 20s are creating testosterone at an all-time high. If you could start doing that again, your body will certainly feel and, to some degree, even look a lot younger.

Risks of Using Prescription Testosterone

Older men who don’t have an actual need for prescription testosterone could still see a doctor and potentially have little problem getting their hands on it. There is no agreed upon amount of testosterone a man is supposed to have at any given age. Therefore, practically any amount that’s below average could be interpreted as being low and a justification for the synthetic version.

That’s a pretty risky situation all on its own. It equates to unfettered access to a very powerful drug. However, the FDA is now trying to spread the word that there are some very serious side effects for those taking the drug without an actual need for it. These include:

  • Stroke
  • Heart Attack
  • Death

The Need for New Labels

Aside from getting the word out, the FDA is also requiring that the labels for testosterone be altered. These new labels will point out the associated risks of taking testosterone, which the FDA hopes will help make medical professionals aware of the potential danger the drug represents.

On top of that, the FDA is requiring that all the major manufacturers of the drug launch serious clinical trials aimed at finding out if there’s a serious risk of stroke of heart attack associated with testosterone use.

Testosterone is a very real drug that must be taken with care. Any chest pain, shortness of breath, weakness in any area of the body or slurred speech associated with using it should be a red flag and a reason to seek medical attention absolutely.

Source:

http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm