Aveed (testosterone + castor oil) is a controversial injection drug that is used to treat low testosterone (“Low T”). Unfortunately, millions of men on testosterone replacement therapy could be at risk of life-threatening cardiovascular events. Recent studies indicate that testosterone can double the risk of heart attacks for men over 65, and increase the risk of stroke and death by 30% during the first 90 days of treatment.
What is Aveed?
Aveed is a 3-mL intramuscular testosterone injection that also contains castor oil. Injections are given at initiation of therapy, at 4 weeks, 10 weeks, and every 10 weeks thereafter. Aveed was developed by Endo Pharmaceuticals and approved by the FDA in March 2014, following three rejected applications. Aveed treats hypogonadism, a severe hormonal deficiency often seen in men with missing testicles, cancer, genetic disorders, and brain disorders.
FDA Adds Heart Attack, Stroke Warnings to Testosterone Products
March 3, 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.
Aveed and Blood Clots
Aveed contains testosterone, a Schedule III controlled substance because it is used illicitly by athletes looking to “pump up” the number of oxygen-carrying red blood cells. Aveed also elevates blood pressure, thickens the blood, and makes other physiological changes that increase the risk of blood clots.
Blood clots from testosterone usually form in the legs, in a condition called deep vein thrombosis (DVT). These blood clots can cause serious venous damage. They can also break loose, travel to the lungs, and cause a pulmonary embolism. Testosterone may also increase the risk of arterial blood clots, which can cause heart attacks and strokes.
Studies of Testosterone Heart Risks
- New England Journal of Medicine (2010) — Older men in poor health on testosterone had 5-times as many cardiovascular events; study halted prematurely.
- Journal of the American Medical Association (2013) — 30% more heart attacks, strokes, and deaths in the first 90 days of testosterone treatment in older men.
- PLOS One (2014) — Doubled risk of heart attack for men over 65 on testosterone; tripled increased risk for younger men with heart disease.
Aveed Black Box Warning for Pulmonary Oil Microembolism (POME)
Aveed contains castor oil, and it carries a “Black Box” warning label about the risk of pulmonary oil microembolism (POME), a lung condition in which blood vessels are clogged by tiny droplets of oil. POME can occur during or after an injection of Aveed, even if the drug is administered slowly. Concern about this side effect delayed approval since 2007.
Symptoms of POME within 24 hours of the injection:
- Cough
- Shortness of breath (dyspnea)
- Throat irritation
- General feeling of illness (malaise)
- Profuse sweating
- Chest pain
- Dizziness
- Tingling or burning sensation (paresthesia)
- Loss of consciousness
- Circulatory collapse
- Loss of bowel function
Consumer Advocates Call Black Box and Delay on Aveed Approval
Public Citizen, a Washington D.C.-based consumer watchdog organization, petitioned the FDA to delay approval of Aveed and add a “Black Box” warning label on all testosterone products about the risk of cardiovascular events.
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.”
Aveed Side Effects
- Heart attack
- Stroke
- Blood clots
- Pulmonary embolism
- Pulmonary oil microembolism (POME)
- Anaphylaxis
- Irregular heartbeat (arrhythmia)
- Anemia
- Heart failure
- Male breast growth
- Prostate cancer
- Acne
- Testicle shrinkage
- Decreased sperm production
- Lifetime commitment to testosterone supplements
- Death
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