Aveed (testosterone + castor oil) was approved in March 2014, following three rejected applications from the FDA and outcry from consumer advocates concerned about the lack of warnings about blood clots, heart attacks, strokes, and other deadly side effects.
Need a Texas Aveed Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by Aveed, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
What is Aveed?
Aveed (testosterone + castor oil), manufactured by Endo Pharmaceuticals, was approved in March 2014 for the treatment of hypogonadism, a debilitating condition in which the testicles produce insufficient or no testosterone. Aveed is a 3-mL intramuscular injection that is administered once at initiation of therapy, once at four weeks, and once every 10 weeks thereafter.
Aveed is Newest Product in Testosterone Therapy Craze
The popularity of testosterone replacement therapy increased five-fold between 2000 and 2011, largely due to aggressive direct-to-consumer advertisements urging middle-aged men to talk to their doctor about “Low T” or low testosterone. These ads suggested that testosterone therapy could cure many of the common, unpleasant, but normal aspects of aging — lower energy, depressed mood, sagging muscles, decreased interest in sex, and more.
Aveed is not a “fountain of youth.” Testosterone levels naturally decline after age 30, and the body may have good reasons for doing so — recent studies indicate that testosterone supplements in older men may increase the risk of heart attacks, stroke, and death. In addition, products like Aveed are not to be taken lightly — they are a lifetime commitment, because the body stops producing its own testosterone
Aveed and Blood Clots
Aveed contains testosterone, a hormone that can elevate blood pressure, increase the number of red blood cells, thicken the blood, and make other physiological changes that can cause blood clots. In most cases, these blood clots form inside the legs, in a condition called deep vein thrombosis (DVT). However, if a blood clot breaks loose, it can travel to the lungs and cause a pulmonary embolism. Blood clots that grow in arteries can cause heart attacks or strokes.
FDA Warning for Testosterone Heart Attack, Stroke Risk
March 4, 2015 — In a Safety Communication, the FDA is asking manufacturers of testosterone replacement products to stop marketing them for the treatment of age-related “Low T,” add warnings about heart attacks and strokes, and start studying the long-term risks. Click here to read more.
Public Citizen Calls for Aveed Approval Delay
In February 2014, the D.C.-based consumer advocacy group Public Citizen filed a petition (.PDF) with the FDA requesting a Black Box warning label about cardiovascular risks on all testosterone products. They recommended delaying approval of Aveed until such warnings are in place:
“We urge the FDA to delay its decision date on approving a new long-acting injectable testosterone product Aveed (testosterone undecanoate, Endo), now set for February 28, 2014, because its approval, absent the new black box warning, would cause further cardiovascular harm to patients for whom this new formulation is prescribed.”
Studies Link Testosterone and Heart Attack, Stroke, Death Risk
Three major studies published since 2010 have linked the use of testosterone to an increased risk of cardiovascular events, especially for men over 65 and younger men with heart disease. These studies include:
- New England Journal of Medicine (2010) — Clinical trial halted prematurely after older men in poor health on testosterone had 5-times as many cardiovascular events as similar men who were not on testosterone.
- Journal of the American Medical Association (2013) — During the first 90 days of testosterone therapy, there were 30% more heart attacks, strokes, and deaths.
- PLOS One (2014) — Men over 65 on testosterone had twice as many heart attacks as men who were not on testosterone. Men under 65 with pre-existing heart disease who used testosterone had a tripled risk of heart attack.
Aveed Side Effects
Unlike other testosterone products, Aveed contains castor oil, and it carries a Black Box Warning about the risk of pulmonary oil microembolism (POME). This serious lung condition occurs when tiny droplets of oil clog blood vessels. During clinical trials, cases of POME were reported during or shortly after injections of Aveed.
Aveed side effects include:
- Heart attack
- Blood clots
- Pulmonary embolism
- Pulmonary oil microembolism (POME)
- Irregular heartbeat (arrhythmia)
- Heart failure
- Male breast growth
- Prostate cancer
Need an Aveed Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Aveed lawyers for a free lawsuit review.