We have won more than $40 billion in jury verdicts and settlements and have been in business for almost 70 years.
The testosterone lawsuits claim the products are linked to an increased risk of heart attacks and strokes, and that the products provide no benefit to the user, and the manufacturer misled the public with fraudulent marketing.
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 2011.
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.
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.”
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.
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.
Second U.S. jury finds AbbVie misrepresented risks of AndroGel
A U.S. jury on Thursday ordered AbbVie Inc to pay more than $140 million to a man who claimed the company misrepresented the risks of its testosterone replacement drug AndroGel, causing him to suffer a heart attack. To read more, click Reuters Testosterone Verdict
Pharmaceutical Company Abbvie Hit With $150 Million Jury Verdict For Falsely Marketing Testosterone Product To Older Men
A federal jury in Illinois ordered pharmaceutical company AbbVie to pay $150 million in punitive damages to a plaintiff who alleged that his heart attack was the result of using its testosterone-boosting product, AndroGel. Although the jury found that AbbVie was not liable for the plaintiff’s injury, they ruled that the company had engaged in fraudulent and misleading advertising. To read more, click Mass Torts Made Perfect Low T Verdict
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 FDA also required that the manufacturers warn about the increased risk of heart attacks and strokes.
The FDA stated the following as part of its mandate: “The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone. We are requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. We are also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.” Reported in FDA Testosterone Safety Communication.
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