Men or loved ones of those who experienced severe side effects of Testim gel have filed lawsuits against manufacturer, Endo and co-marketer, Glaxo. The lawsuits claim that Endo and its subsidiaries misrepresented the risks of testosterone replacement therapy, particularly with regards to cardiovascular risks of heart attack and stroke, along with disorders caused by blood clotting. In early 2018, Endo and Glaxo had indicated they would be offering settlements for more than 1,300 Testim lawsuits but the terms of those settlements was not defined.
The settlement agreement took pending trials which had been scheduled, off of the court’s docket, however more Testim lawsuits may be expected.
Testim Side Effects
Testosterone regulates growth and the development of male gender characteristics. When applied topically, Testim gel increases bone density, muscle growth and libido, enhances sexual function and increases energy levels. The formulation was designed for use in men aged 18 and older who do not produce enough natural testosterone due to a malfunction of the testes, known as hypogonadism.
Unfortunately, many men have been prescribed testosterone gel and replacement therapy for age-related decline of male hormones or “low-T” which has been a popular advertising subject. This use of testosterone is not approved by the FDA and may increase the chance for serious complications. Some lawsuits have claimed that manufacturers of testosterone replacement products like Testim have encouraged physicians to prescribe their products for unverified cases of low testosterone or Low-T.
Serious side effects and complications of Testim can include:
- Blood clots
- Heart attack
- Pulmonary embolism
- Deep vein thrombosis (DVT)
- Venous thromboembolism (VTE)
Testim FDA Warnings
Testim is one of a larger group of testosterone replacement therapy medications. It was approved for the treatment of
Testim is a testosterone therapy medication approved for the treatment of low testosterone levels in those who have a medical condition known as hypogonadism. It was approved in 2002 as a 1% testosterone gel formulation to be applied to the skin on a daily basis. Testim was originally manufactured by Auxilium Pharmaceuticals as a competitor to the more popular AndroGel, and brought the company $212 million in revenue in 2013. Auxilium was acquired by Endo, who co-marketed Testim with pharmaceutical giant, Glaxo.
Two studies published in the Journal of the American Medical Association (JAMA), showed that Testim and similar medications are linked to a higher risk of cardiovascular diseases which can lead to heart attack or stroke. The studies showed that men who are treated with hormone supplement therapy may experience heart attack or stroke at a three times greater rate than those who do not take the medications.
In light of the two published studies, the Food and Drug Administration (FDA) announced on January 31, 2014, that the administration was in the process of investigating the risks associated with hormone supplementation using Testim and similar products.
March 2015, the FDA ordered Testim and other testosterone manufacturers to update product labels with information about an increased risk of heart attack and stroke. In June of 2015, the labels were again updated to include a warning regarding a risk of venous thromboembolism (VTE), venous blood clots that include deep vein thrombosis (DVT) and pulmonary embolism (PE) which may be fatal.
In February of 2018, Endo Pharmaceuticals and GlaxoSmithKline agreed to settle lawsuits that accused the drug manufacturers of hiding risks of Testim, which was marketed towards middle-aged men. Endo had previously won a single case filed by the family of a man who died from heart attack while using Testim. In that trial the jury decided that the man had other health conditions which may have contributed to his death.
Despite that win, Endo and Glaxo were facing another round of lawsuits. Just before a bellwether case was slated to be tried in Philadelphia, the companies agreed to resolve more than 1,300 Testim lawsuits for an undisclosed amount. In June 2018, Endo announced they had set aside $200 million for these claims but more lawsuits may be expected. Other testosterone lawsuits have resulted in awards which ranged from $thousands to $millions.
Men or loved ones of those who experienced heart attack, stroke, pulmonary embolism, or clotting disorders after using Testim gel, should have their case evaluated by a legal expert. Though each case is unique and must be considered separately, a Testim lawsuit may provide compensation for medical costs, lost wages, pain and suffering or for wrongful death.