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FDA Approves Aveed Testosterone Despite Safety Concerns


March 6, 2014 — Endo Pharmaceuticals has received approval for Aveed (testosterone and castor oil injection), following three rejections from the U.S. Food and Drug Administration (FDA) and a petition from consumer advocates to delay approval, citing concern about blood clots, heart attacks, stroke, and death.

Aveed is a 3-mL intramuscular injection of testosterone that is administered once at initiation of therapy, at 4 weeks, and every 10 weeks thereafter. It also contains castor oil. It carries a Boxed Warning about pulmonary oil microembolism (POME), a condition in which tiny droplets of oil get trapped in the lungs.

Public Citizen, a D.C.-based consumer advocacy group, filed a petition asking the FDA to require a Boxed Warning about cardiovascular side effects of all testosterone replacement products. They asked the FDA to delay approving Aveed until such warnings are in place. Click here to read more.

According to the petition (.PDF):

“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.”

Aveed is approved to treat male hypogonadism, a medical condition in which the testicles produce little or no testosterone. However, in recent years, testosterone replacement therapy has been marketed as a cure-all for normal aspects of aging — fatigue, decreased muscle mass, low sex drive, depression, and more. As a result, millions of men without hypogonadism are on testosterone.

The problem is that testosterone is not a “fountain of youth” — it is a lifetime commitment with life-threatening risks. Testosterone is a Schedule III controlled substance because athletes use it to increase the number of oxygen-carrying red blood cells. Not surprisingly, recent studies indicate that testosterone may also increase the risk of blood clots — especially for men over 65 and younger men with heart disease.

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