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The Testosterone Replacement Therapy Drug Lawsuit

Testosterone, a sex hormone produced in a male’s body, regulates sex drive, bone mass, fat distribution, muscle mass, strength, and production of red blood cells and sperm. Men who suffer from low testosterone may experience a reduced desire for sex, fewer erections, infertility, increased body fat, fragile bones, and increased fatigue.

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What is Testosterone Replacement Therapy?

Men who experience low testosterone may be able to increase their levels through testosterone replacement therapy. In fact, testosterone replacement therapy is available in several forms including skin patches, gels, mouth patches, injections, and implants. Unfortunately, recent reports indicate that some types of testosterone replacement therapies may cause severe and potentially life-threatening physical problems in men. In fact, hormone replacement therapies may increase the risk of heart attack, stroke, pulmonary embolism, and deep vein thrombosis. Companies such as Pfizer and Pharmacia & Upjohn have made millions of dollars marketing, manufacturing and selling testosterone replacement medications. Common testosterone replacement therapies include products such as Depo-Testosterone, Delatestryl, AndroGel, Androderm, Fortesta, Testin, and Testopel.

What is Testosterone Replacement Therapy used for?

Testosterone replacement therapy can help men who are not producing sufficient amounts of testosterone naturally in their body. Testosterone therapy can do the following:

  • Correct hormonal imbalances
  • Increase bone density
  • Regulate fat distribution
  • Increase muscle mass and strength
  • Increase facial hair
  • Increase sex drive
  • Increase sperm production
  • Increase red cell production

Testosterone Replacement Therapy Usage and Statistics

There are a number of different companies offering a wide variety of testosterone replacement modalities within the United States. Patients must work directly with their doctors to determine the advantages and disadvantages of each product. Reports indicate that the use of testosterone replacement products has been climbing rapidly for a number of years. Medical experts are concerned that many men may be abusing the medication and may be taking the powerful hormone when there is no evidence of a deficiency. In fact, a number of men have been prescribed the medication without the necessary blood tests to determine their hormone levels. Men who have been prescribed testosterone are generally in their 40s and take it for the treatment of erectile dysfunction, low testosterone, or hypogonadism and fatigue. Low testosterone can contribute to depression, erectile dysfunction, diabetes, osteoporosis, heart disease, and hot flashes, but hormone therapy can also cause minor to severe side-effects such as acne, blood thickening, and increased risk of heart disease. Some medical experts also suggest these medications may increase the risk of prostate cancer, although other experts dispute this suggestion. Regardless of the current risks, millions of men have sought hormone replacement therapy and many are at-risk for certain conditions and diseases.

How Testosterone Replacement Therapy Works

Testosterone is sex hormone which is normally produced in a man’s testicles. As a man ages, however, it is not unusual for the body to gradually produce less testosterone. Low testosterone can also be caused by a variety of other factors such as radiation and chemotherapy for cancer, injury, infection, genetic defect, too much iron in the body, malfunction of the pituitary gland, inflammatory diseases, medications, chronic kidney failure, cirrhosis of the liver, alcoholism, obesity, stress, and chronic illness.

Side Effects of Testosterone Replacement Therapy

  • Benign prostatic hypertrophy
  • Prostate cancer
  • Sleep apnea
  • Blood clots
  • Deep vein thrombosis
  • Pulmonary embolism
  • Worsen Congestive heart failure
  • Breast swelling
  • Headaches
  • Anxiety
  • Increased facial hair
  • Increased male-pattern baldness
  • Increased or decreased interest in sex
  • Numbness or tingling
  • Pain and swelling at injection site.

Testosterone Replacement Therapy Medical Studies

In an article titled, A Harvard expert shares his thoughts on testosterone-replacement therapy, by Abraham Morgentaler, M.D., suggested that although there have been a number of smaller studies on men receiving testosterone-replacement therapy, there are not any large-scale, randomized, controlled clinical trials of testosterone-replacement therapy currently under way. When he reviewed smaller studies on men receiving testosterone-replacement therapy he concluded that the rate of prostate cancer in these men was about 1% per year, but he noted that if you compare the rate of prostate cancer with the same aged population who came for prostate screenings, the rate was comparable to those taking testosterone treatment. With this in mind, he argued, “There was no signal in these results that testosterone-replacement therapy creates an unexpectedly high rate of prostate cancer.” Other studies have been done in publications such as the Physicians’ Health Study, the Baltimore Longitudinal Study of Aging, and the Massachusetts Male Aging Study. These studies followed tens of thousands of men for 5, 10, 15, or even 20 years. Researchers concluded that these studies also did not show a “definitive correlation between prostate cancer and total testosterone.”

Testosterone Replacement Therapy Black Box Warnings

  • Not all men should take testosterone replacement medications. Notify your doctor if you have breast cancer, prostate cancer, a serious heart condition, a severe liver condition, diabetes, enlarged prostate, history of blood clots, or a severe kidney disease. Men who are taking blood thinner medications and women who are pregnant or planning to become pregnant should also consult with their doctor before taking any type of hormone replacement therapy. Men taking any type of testosterone replacement therapy medications should contact a doctor immediately if they experience any of the following:
  • Hives
  • Vomiting
  • Impotence
  • Decreased testicle size
  • Swelling of the face, tongue, lips or throat
  • Trouble breathing
  • Changes in skin color
  • Constant erection
  • Painful urination
  • Shortness of breath
  • Swelling in ankles or feet
  • Unexpected, rapid weight gain
  • Signs of blood clots
  • Chest pain
  • Wheezing
  • Rapid breathing
  • Coughing
  • Coughing up blood
  • Stomach pain
  • Confusion
  • Feeling tired or restless
  • Liver problems
  • Loss of appetite
  • Dark urine
  • Jaundice
  • Upper stomach pain
  • Muscle weakness

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