March 6, 2014 — The U.S. Food and Drug Administration (FDA) has approved Aveed, a prescription testosterone injection that contains castor oil, after three rejected applications and against the recommendation of a consumer safety organization.
Aveed, manufactured by Endo Pharmaceuticals Inc., is approved to treat hypogonadism, a condition that affects millions of American men who struggle with low testosterone levels. Aveed was approved after an 84-week placebo-controlled trial involving men in their 50s. The drug is injected intramuscularly — one initially, one at four weeks, and one every 10 weeks thereafter.
Aveed already carries a Black Box Warning about anaphylaxis and pulmonary oil microembolism (POME), a serious lung problem caused by tiny droplets of castor oil that have traveled to the lungs. However, it does not contain warnings about deadly cardiovascular events.
Public Citizen, a consumer advocacy group, petitioned (.PDF) the FDA to require a Black Box Warning about cardiovascular risks of testosterone. They also asked the FDA to delay approval of Aveed, expressing concern about recent studies linking testosterone replacement therapy to an increased risk of blood clots, heart attacks, strokes, and death in older men. Click here to read more.
According to the petition:
“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.”
Testosterone replacement therapy is promoted as a way to help middle-aged men regain energy, sexual function, muscle mass, and more. The drug is also used as a performance-enhancing supplement for athletes because it increases the number of oxygen-carrying red blood cells. Not surprisingly, this can potentially increase the risk of blood clots, especially in older men and people with heart disease.
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