What You Need to Know About AndroGel®

Posted on Thursday, July 12th, 2018 at 3:07 pm    

The use of testosterone therapy drugs like AndroGel surged this decade, peaking at nearly five million total prescriptions in 2013.1 However, the U.S. Food and Drug Association (FDA) recently linked testosterone therapy with some serious health conditions. AndroGel has since been implicated as the cause of injury in more than 6,000 lawsuits.2 Here’s what AndroGel users and family members of users need to know to ensure their safety and protection.

What is AndroGel?

AndroGel is the most popular testosterone therapy drug available on the market. Of the 1.8 million total testosterone gel prescriptions in 2017, more than 994,000 were for AndroGel.1

The testosterone therapy gel is used to increase or replace testosterone in men with abnormally low or no testosterone. This condition is called hypogonadism, and it can be caused by many factors, including illness, trauma to the testicles, pituitary gland or hypothalamus issues or a side effect of chemotherapy.

Ample testosterone levels are important as they help maintain critical bodily processes, including:

  • Bone density
  • Fat distribution
  • Muscle mass
  • Sperm production and vitality

What Are the Concerns?

In recent years, drug manufacturers shifted their marketing campaigns to advertise products like AndroGel as a solution to “low T” and the natural effects of aging, such as fatigue, low sex drive and increased body fat. Essentially, a drug designed to replace testosterone in men with serious health problems began to be improperly prescribed to treat the normal effects of aging, leading to adverse effects.1

The concerns are larger than misleading advertising. In early 2014, the FDA began investigating whether testosterone therapy products increase the likelihood of potentially life-threatening side effects, such as heart attack, blood clots and stroke.

The FDA later issued a warning stating the product is not designed to treat low testosterone levels due to aging. All manufacturers are now required to provide a warning of increased risk of heart attack and stroke on the label. Additionally, the FDA states patients experiencing chest pain, shortness of breath, weakness in one part of the body or slurred speech while using testosterone therapy should seek immediate medical attention.5

A January 2014 study found that men with pre-existing heart conditions taking testosterone have a “substantially” higher risk of heart attack, while another in March 2014 concluded men undergoing testosterone therapy have an “increased risk of adverse outcomes.”3,4

Ongoing Legal Precedent

More than 6,000 people have filed lawsuits against AndroGel manufacturer, AbbVie, alleging that the company promoted the product as cure for “low T,” while failing to advertise that the drug was only approved for hypogonadism and has potentially deadly side effects.2 The lawsuits have had mixed results.

Most recently, a jury decided that AndroGel was not to blame when a 72-year-old Arizona retiree suffered from a pulmonary embolism after using the drug for more than two years. AbbVie’s attorneys successfully argued that a genetic predisposition to heart problems and his own choices were to blame.1

Just months prior, two separate cases heard in Chicago federal courts resulted in favor of the plaintiffs – one was awarded a $150 million verdict and the other $140 million. Both plaintiffs suffered heart attacks while using AndroGel. Despite AbbVie convincing the judge to throw out the $150 million verdict, the plaintiff was awarded more than $3 million in punitive and compensatory damages after a second trial.6

These are just a few examples of the ongoing product liability battle between the thousands of men who claim AbbVie’s drug has caused them serious injuries. The manufacturer has been named the defendant in more than 4,000 cases as of June 2018.2

Product Liability Compensation

Product liability cases like these hold negligent product manufacturers accountable for causing serious injury to consumers. The attorneys at Farris, Riley & Pitt, LLP have many years of experience handling dangerous drug cases in Alabama. If you or a family member were seriously injured while using a testosterone drug like AndroGel, you may be entitled to financial compensation.

To find out if you have a case by calling (205) 324-1212 or filling out the form on our website for a FREE consultation.

1 https://www.chicagotribune.com/business/ct-biz-abbvie-androgel-lawsuits-20180205-story.html

2 https://www.drugwatch.com/news/2018/04/26/androgel-testosterone-lawsuits-set-for-federal-trials/

3 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0085805

4 https://www.ncbi.nlm.nih.gov/pubmed/24193080

5 https://www.fda.gov/Drugs/DrugSafety/ucm436259.htm

6 https://www.drugwatch.com/news/2018/03/27/jurors-award-3-2m-verdict-androgel-lawsuit/

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