Apr 28th, 2015
by admin

Testosterone Boosters – FDA Introduces New Regulations

Makers of approved testosterone products must revise their labels, according to new rules announced by the U.S. Food and Drug Administration (FDA) on March 3, 2015. Labels must now clarify that testosterone therapy is FDA-approved only for men with hypogonadism – low testosterone caused by a medical condition. It is not approved for age-related testosterone declines.

new testosterone rules from the fda
The FDA also requires that manufacturers note possible cardiovascular risks, after studies have found an increased risk of heart attack and stroke in some men taking testosterone. This change is a controversial one, as some experts have questioned the reliability of the studies. Others say that testosterone does not increase the risk of heart problems and may even be protective. Millions of men currently buy testosterone boosters as a means to improve their erections and overall sexual performance.

Testosterone therapy has become increasingly common in older men, and research shows that the number of testosterone prescriptions have tripled over the past decade, causing researchers to sound the alarm that men may be abusing the hormone. The problem is – many of these men probably don’t require testosterone therapy.

To determine this, you have to actually test your testosterone level, which is done with a blood test—ideally more than once, as your testosterone level can rise and fall during each day. The current findings indicate that 25 percent of men given a prescription for testosterone did not have their levels tested prior to receiving a prescription, and of the remaining 75 percent, it was unclear as to how many actually had a testosterone deficiency.


 

Potential side effects of testosterone replacement therapy for men

  1. Increased risk of heart disease
  2. Thickening of blood and/or blood clots
  3. Reduced sperm count
  4. Increased risk of prostate cancer
  5. Liver Problems
  6. Increased male pattern baldness
  7. Male breast growth
  8. Male infertility
  9. Acne
  10. Worsening of urinary symptoms

 

In men, testosterone is produced by the testes. This hormone gives men their masculine characteristics, including facial hair, a lower voice, and increased muscle mass. It’s also important for men’s reproductive health and helps drive their libido. The FDA has approved prescription testosterone for men with low levels due to hypogonadism. For these men, problems with testes, pituitary gland, and other parts of the brain prevent the body from making enough testosterone. Cancer treatment can also cause hypogonadism in men.

While primarily associated with male sexuality and reproduction, testosterone also plays a role in maintaining muscle mass, bone density, levels of red blood cells, and a general sense of vigor and well-being. Symptoms of declining testosterone levels include decreased sex drive, erectile dysfunction, depressed mood, and difficulties with concentration and memory. Men with low testosterone may also experience weight gain, breast enlargement, and problems urinating.

Men’s testosterone levels decline as they get older, too. This can make them feel tired, depressed, and less interested in sex. But this type of low testosterone is not the same as hypogonadism. Some doctors prescribe testosterone to men who have age-related low testosterone, not hypogonadism. This concerns the FDA, as testosterone is not approved for this use. More research is needed to determine how safe and effective it is. With the new labeling requirements, manufacturers will clarify the approved uses of testosterone. The FDA is also concerned that testosterone use might increase the risk of heart attack and stroke in some patients. This issue has been controversial, with research showing mixed results. Some studies have found increased risk, some have not. Many testosterone boosters are sold with exaggerated claims about how much they can increase a man’s testosterone production.


testosterone therapy in men
Experts have also questioned the reliability of studies that show increased risk, as they have found problems in the data and methodology. In addition to revising product labels, the FDA is also requiring manufacturers to conduct more research to learn more about this potential risk. In the meantime, patients taking testosterone are advised to watch for symptoms of heart attack and stroke, such as chest pain, shortness of breath, weakness, and slurred speech. If these symptoms occur, men should see a doctor immediately.

What’s the bottom line? The fact is a large number of men taking testosterone supplements don’t really need it – and may in fact be endangering their health with no tangible benefits from using testosterone. If you’re a man taking testosterone that wasn’t prescribed by a doctor who actually tested you testosterone levels – a discussion with your physician is in order. If you’re simply taking testosterone for it’s benefits with erectile function and sexual performance – there are several natural options that offer superior results without any of the negative side effects.

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