AndroGel is a form of testosterone replacement medication which is available in a topical gel form to be applied daily. It is approved to treat low testosterone levels caused by a medical condition known as hypogonadism. Unfortunately, many men who have taken it were exposed to a higher than normal risk for life-threatening events, without ever having been tested for low hormones.
AndroGel was one of several medications which were marketed to treat symptoms of “Low-T” in television commercials, in print ads and on the internet. Low-T was not a diagnosis but a marketing term, coined to describe symptoms of low testosterone in male patients including lack of energy, loss of sex drive and general fatigue.
Many of the supposed symptoms of Low-T were actually normal signs of aging, not a medical condition and did not warrant medical treatment. Some evidence suggests that the majority of men who used AndroGel and other medications for “Low-T” were never tested for low testosterone levels and may have been given the prescription drug unnecessarily. This may have exposed them to serious risks which were life-threatening with no clear medical reason.
AbbVie and other testosterone product manufacturers have been accused of improper marketing and of hiding or downplaying the risk of AndroGel and other drugs.
Men who used AndroGel or other testosterone replacement products may be subject to a two to three times greater risk for serious side effects which may be life-threatening.
These effects may include:
- Heart attack
- Deep vein thrombosis
- Venous thromboembolism
- Pulmonary embolism
Any of these events may become fatal and result in death.
In 2014, based on publication of two large studies which showed a higher-than-normal risk of heart attack and cardiovascular events like stroke, the Food and Drug Administration (FDA) issued a safety notification, indicating that they were launching an investigation. In mid-2015, based on results of the investigation, the agency required that manufacturers include additional safety warnings on AndroGel and all testosterone products regarding the increased risks.
This was the second change to labeling about testosterone safety after a separate warning had been added in mid-2014 regarding an increased risk of blood clotting events such as deep vein thrombosis. Both the 2014 and 2015 changes include a higher than normal risk of potentially fatal events.
Men who were prescribed or used AndroGel and who experienced a side effect such as heart attack, stroke or clotting event, or loved ones of those who died after using AndroGel, may be eligible for compensation and should seek legal advice.
AbbVie has recently announced that they have been in negotiations for a settlement agreement and though there are no guarantees, an AndroGel lawsuit may provide compensation for medical costs, lost wages, pain and suffering or wrongful death.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.