In recent years, the use of testosterone therapy drugs for the treatment of “low T” has gained popularity, with more than 5 million testosterone prescriptions written in the United States in just 2011 alone. Testosterone therapy is typically administered as a gel, patch, or injection, and has been marketed and prescribed to improve sex drive, muscle mass, and bone density in those suffering from low testosterone.
Recent studies, however, have shown an increased risk of myocardial infarction (heart attacks) and ischemic stroke associated with the use of testosterone therapy products. Such products, including AndroGel, Axiron, and Androderm, are thought to be increasing the risk of such serious cardiovascular issues.
The risk of heart attack and stroke for a user of testosterone products nearly doubles when compared to those who don't use testosterone. Given the enormous (and growing) sales of prescription testosterone products, this could mean a large number of heart attacks have occurred in the general population that otherwise would not have occurred.
If you were to discuss low testosterone with a medical professional, he or she would likely tell you that it is a normal part of aging. Unlike women, who experience a relatively sudden shutdown in the production of estrogen around age 50 (menopause), the decrease of testosterone in males is gradual, starting around age 30. By age 45, approximately 40% of all men are effected.
Why is Testosterone Utilized
Testosterone therapy drugs have been FDA-approved for the treatment of hypogonadism, a medical condition occurring in men where the male sex organs produce little or no testosterone hormone. Testosterone therapy is designed to work by replacing the absent naturally-occurring testosterone that is produced by the body.
Natural testosterone production in the body plays a significant role in male characteristics, mood, and sex drive. Men experiencing low levels of testosterone can have a number of unfavorable symptoms, including fatigue, low libido, and depression. As men age, they may experience dips in testosterone levels, and it is part of the natural-aging process to experience such an event. It is not a reason Testosterone therapy drugs were approved by the FDA, which is specifically for the medical condition hypogonadism.
Over the last several years, the testosterone product market has grown significantly, largely in part to aggressive marketing campaigns by testosterone manufacturers that have generalized symptoms for low testosterone, which has been coined “Low T.”
What Are The Various Testosterone Drugs Prescribed
A topical testosterone gel that is applied by the user to the upper arms and shoulder. Manufactured by AbbVie Inc., AndroGel is prescribed is available
Testosterone is administered through a transdermal patch that is applied to the skin in the back, stomach, thighs, or arms. Androderm is available in 2 and 4 mg strengths, and is applied daily. Androderm is manufactured by Actavis, Inc. (previously Watson Pharmacueticals), and was approved by the FDA in 1995.Android
An oral testosterone drug that is taken up to four times a day. Methyltestosterone, the active ingredient found in Android, is similar to natural testosterone that is produced by the body, and belongs to a class of drugs known as androgens.Axiron
A topical testosterone product that is applied to the armpits in a manner similar to applying deodorant. Axiron was approved by the FDA in 20120 and is manufactured by Eli Lilly, Inc.Fortesta
A daily testosterone spray gel that is applied to the front and inner thighs. Fortesta is manufactured by Endo Pharmaceuticals and was approved by the FDA in December 2010.Striant
A mucoadhevise tablet-like system that adheres to the inner cheek or gum to provide the patient with controlled and sustained release of testosterone into the body. The tablet, containing approximately 30 mg of testosterone, slowly releases the hormone into the mucous membranes of the mouth. Originally manufactured by Columbia Laboratories, Inc., Striant was purchased by Auxilium Pharmacueticals in April 2011.Testim
A popularly prescribed testosterone gel that is applied to the shoulders daily. It was approved by the FDA in 2002 and is manufactured by Auxilium Pharmacueticals, Inc.Testopel
A testosterone implant that is placed under the skin. The implant, containing approximately 75 mg of testosterone, releases the hormone into a patient’s body for a period of 3-4 months. Testopel was approed by the FDA in 2008 and is manufactured by Auxilium Pharmacueticals, Inc.Testred
Like Android, Testred is also an oral testosterone drug that is taken up to four times a day. Methyltestosterone, the active ingredient found in Testred and Android, is similar to natural testosterone that is produced by the body, and belongs to a class of drugs known as androgens.
Testosterone Injuries & Side Effects
Two recent studies, a study published in the medical journal PLOS One as well as a study published online in The Journal of the American Medical Association (JAMA), have linked testosterone products to increased risks of cardiovascular events in men.
The research from the study published in the journal PLOS One concluded that men 65 years of age and older who used prescription testosterone products had double the risk of heart attack within the first three months of using testosterone products. The JAMA study also found that senior males who used testosterone products were 30 percent more likely to suffer from heart attack, stroke, and death when compared to senior males who did not use testosterone products.
|Other Serious Side Effects|
|Worsening symptoms of an enlarged prostate|
|Increased risk of prostate cancer|
|Lower sperm count|
|Swelling of the ankles, feet, or body|
|Enlarged and painful breasts|
|Difficulty breathing during sleep|
|Increased risk of blood clots occurring in the legs|
Testosterone Lawsuit Videos
Testosterone Lawsuit NewsFDA Warns Testosterone Products Not Approved for Use in Treating Low Testosterone as a Result of Aging
The U.S. Food and Drug Administration (FDA) issued a Safety Announcement on March 3 warning the public that testosterone products are not approved for use in treating low testosterone as a result of aging. The warning addresses increased prescription of testosterone therapy to treat males suffering from low testosterone as a result of aging and requires manufacturers to change their labels to reflect this information. To read more, click Drug Safety NewsTestosterone Prescriptions Boom as Risk of Heart Attack is Ignored
For many men, the act of growing older can be a troubling time in their lives. They experience lethargy, lowered libido, less mental acuity. It’s part of the process of aging. Pharmaceutical companies, however, have taken issue with mother nature’s course and decided that they testosterone therapies are the cure for what aging causes. The condition is commonly referred to as Low-T (Low Testosterone) and the treatments may be causing more damage than is being disclosed. To read more, click The Ring of FireFDA Strengthens Warning Label For Testosterone Therapy Dangers
The U.S. Food and Drug Administration (FDA) announced that it will strengthen the label on testosterone treatments to warn about the risks of developing blood clots. Testosterone treatments have been associated with a number of cardiological problems among patients who use it. To read more, click The Ring of Fire
Testosterone Recall Information
As of this time, a Testosterone recall has not occurred. However, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement on March 3, 2015. warning the public that testosterone products are not approved for use in treating low testosterone as a result of aging. The warning addresses increased prescription of testosterone therapy to treat males suffering from low testosterone as a result of aging and requires manufacturers to change their labels to reflect this information. Testosterone therapy has been approved only for treatment of low testosterone as a result of disorders of the testicles, pituitary gland, or brain, causing a condition known as hypogonadism. No other Indications have been approved by the FDA because there is sparse data supporting the efficacy of testosterone for patients that don’t suffer from the aforementioned diseases.