Testopel is an injectable pellet formulation for testosterone replacement therapy in men who do not produce normal amounts of testosterone. Like many other testosterone brands, Testopel was aggressively marketed for a non-medical condition called “Low-T” but never had testosterone levels tested.
Symptoms of Low-T may have been normal symptoms of aging and many men who took Testopel may have been exposed to unnecessary risks including:
- Blood clots
- Pulmonary embolism
- Heart attack
Testopel’s manufacturer, Endo Pharmaceuticals has been the target of multiple Testopel lawsuits and lawsuits for their other testosterone products. These lawsuits claim the company inappropriately marketed their medications and placed Testopel users at increased risk of serious side effects.
Men who have filed lawsuits against Endo Pharmaceuticals and its predecessor, Auxilium pharmaceuticals have claimed that they suffered heart attacks, stroke and other serious side effects. In some cases, family members of men who died have filed wrongful death lawsuits.
Endo has faced thousands of testosterone lawsuits for its testosterone replacement products, including Testopel. The company set aside $200 million to settle about 1,300 testosterone lawsuits, though most of these involved another Endo product, Testim. No specific announcements have been made regarding Testim, but cases may still be pending.
Testopel is an injectable pellet form of testosterone which is intended to be administered every 4 to 6 months for the treatment of low testosterone levels due to hypogonadism. Like many testosterone products, Testopel was inappropriately marketed for “Low-T”, a non-medical condition with symptoms that may have been caused by normal aging processes. Many men who used Testopel for Low-T never had their testosterone levels tested and may have been placed at high risk for serious side effects and complications.
Men who took Testopel injections and who experienced serious side effects or loved ones of those who died due to testosterone pellet injections have filed lawsuits against manufacturer, Endo Pharmaceuticals. These lawsuits claim that Endo and its acquired company Auxilium, misled the public about the use of testosterone replacement therapy and downplayed the risks of dangerous side effects.
Men who used Testopel or other types of testosterone therapy may have been placed at greater risk for:
- Blood clots
- Heart attack
- Pulmonary embolism
- Deep vein thrombosis
- Venous thromboembolism
Testopel is the only pellet injection form of testosterone replacement therapy approved by the Food and Drug Administration (FDA). Unlike other testosterone replacement medications which require daily application or use, Testopel secretes male hormone into the blood stream for up to six months, making it a preferred method of treatment for many men.
Testopel is only approved to treat low testosterone levels that occur due to hypogonadism, but many men may have used the treatment to combat natural signs of aging such as decreased libido, lack of energy and muscle loss. Unfortunately, like other testosterone treatments, Testopel has been shown to cause serious side effects.
Recent studies have linked testosterone therapy to increased risks of heart attack, stroke, pulmonary embolism and blood clots, all of which may result in death. Patients that are being treated without proper testing to determine need are being placed at an unnecessary risk. The most recent study published on PLOS ONE stated that only two percent of men undergoing testosterone therapy suffer from either form of hypogonadism.
Testopel FDA Warnings
Testosterone-related heart attack, stroke and pulmonary embolism can be a result of an increased risk of blood clot formation such as deep vein thrombosis or due to changes in cholesterol metabolism that may also increase the chance for venous embolism.
The FDA released a safety announcement on January 31, 2014 regarding the risks associated with testosterone and announcing that they were to begin further investigation into the safety of these products. This announcement was followed in 2015 with a requirement for changes in safety warnings.
The agency required that Testopel pellet injection and other testosterone medications have information about heart attack and other cardiovascular events be added to prescribing information. Separately, in June of 2014, the FDA had required that warnings about an increased risk of blood clots be added to Testopel and other testosterone product labels.
Allegations surround the companies deceiving marketing tactics which imply that the medication could be used to increase male sex drive, gain muscle and improve bone density for “Low-T”, a marketing term which is not an actual diagnosis. Many men who took Testopel and other products were never tested for low testosterone levels but were subject to serious risks, without an approved diagnosis.
In June 2018, Endo pharmaceuticals announced they had set aside $200 million for claims related to another testosterone product, Testim. Though no announcements have been made public, this may indicate that Testopel settlements have been under consideration and similar testosterone lawsuits have resulted in settlements which have ranged from the $thousands to $millions.
Men or loved ones of those who experienced stroke, heart attack, pulmonary embolism, or clotting disorders after receiving Testopel (testosterone pellet) injection, should seek evaluation by a legal expert. Each case is unique and must be considered separately, but a Testopel lawsuit may provide compensation for medical treatment costs, lost wages, future medical costs, pain and suffering or for wrongful death.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.