Perhaps due to a high saturation of marketing messages touting amazing results, men are currently spending more than $2 billion on testosterone replacement therapy each year, and experts say that the sales of these products could reach $5 billion by 2017.

The U.S. Food and Drug Administration (FDA) estimates that 1.5 million men were taking testosterone-replacement products in 2013, almost double the amount of men using them in 2010, and approximately 25 percent of them were taking the products based upon symptoms, not a diagnosed medical condition.

But how safe are these products?

In 2015 alone, the FDA has issued a number of warnings to both physicians and male patients regarding the safety of testosterone replacement drugs, which may increase the risk of heart attack, stroke, and death.

Forms of testosterone formulations include:

  • Gels that are applied once a day and absorbed into the body directly through the skin.
  • Transdermal skin patches that are worn on the arm or upper body one time during the day.
  • Testosterone sticks that are applied directly to the skin, like an underarm deodorant.
  • Injections and implants applied directly into the muscles or implanted as pellets into soft tissues, allowing the body to slowly absorb the testosterone into the blood stream.
  • Mouth patches applied to the upper gum twice a day to continuously release testosterone into the blood through the oral tissues.
  • Testosterone pills such as methyltestosterone and testosterone undecanoate.

Besides heart attack and stroke, testosterone therapy products have other potential side effects, including:

  • Stimulation of prostrate tissue
  • Increased risk of blood clots
  • Hair loss
  • Acne and oily skin
  • Fluid retention
  • Breast enlargement
  • Worsened sleep apnea
  • Shrunken testicles
  • Possible aggression and mood swings
  • Decrease in sperm count

The FDA has approved testosterone replacement products only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition, such as the failure of the testicles to produce testosterone because of genetic problems or chemotherapy, or problems with the hypothalamus and pituitary, the brain structures that control the production of testosterone by the testicles. None of the FDA-approved testosterone products are approved for use in men who lack an associated medical condition such as low testosterone as a result of aging, which is a natural occurrence.

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