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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.
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.”
Side effects of testosterone therapy drugs may include:
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.
AndroGel 1.62%
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
Androderm
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.
Our law firm has been in existence for more than 60 years, and is considered a national leader in this type of litigation. We have received well over 150 jury verdicts throughout the country in the amount of $1 million or more, and achieved verdicts and settlements in excess of $3 billion. We are the founder of Mass Torts Made Perfect, which is a national seminar attended by approximately 800 lawyers twice per year where we help teach the successful handling of cases against pharmaceutical companies. For more information, please visit our About Us section.
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To contact us for a free confidential consult, you can call us at (800) 277-1193 (toll free). You also can request a confidential consultation by clicking Free & Confidential Consult, which form will be immediately reviewed by one of our attorneys handling the Testosterone litigation.
As of this time, there have been no large group settlements involving Testosterone. Litigation likes this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented. Generally, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. This in no way means you can wait to hire an attorney and file a lawsuit. Just the opposite, if you wait, you could permanently lose all of your rights, even if a settlement occurs in the future. This is because every state has time limitations in which you can file a lawsuit for any injuries that you have sustained or could sustain resulting from Testosterone.
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.
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