Testosterone Replacement Therapy

What is Testosterone Therapy?
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.

Is Testosterone Therapy Widely Prescribed?
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.” 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.

Testosterone therapy is most often administered as a gel, patch or injection and includes the following 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 as 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 Pharmaceuticals) 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 2020 and is manufactured by Eli Lilly, Inc.
  • 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 Pharmaceuticals, 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 approved by the FDA in 2008 and is manufactured by Auxilium Pharmaceuticals, Inc.

Testosterone Therapy Dangers and Potential Side Effects
New research has found that testosterone treatments for men could cause an increased risk of stroke, heart attack or even death. Men with signs of heart problems were more likely to suffer a stroke, heart attack or die while taking testosterone supplements. Additionally, younger men with a history of heart disease were three times as likely to suffer a stroke or heart attack while taking the therapy. The study examined medical records of 56,000 men after they filled a prescription for testosterone treatment. The study was published in PLOS ONE, an international, peer-reviewed online publication in January 2014. It is a part of the growing body of research that raises concerns about the increased risk associated with taking testosterone therapy.

Have Testosterone Therapy Drugs Been Recalled?
As of this time a Testosterone Therapy 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.

Contact Scovern Law
If you or someone you know has been affected by Testosterone Therapy and would like to know how Scovern Law can represent you, please don’t hesitate to contact us to review your case and submit a claim at 1.888.725.1890.