June 23, 2014
News Review From Harvard Medical School -- New Blood-Clot Warning for Testosterone
Testosterone products must carry a new warning about a possible risk of blood clots in veins. The U.S. Food and Drug Administration (FDA) announced the change June 20. It is prompted by reports of deep vein thrombosis and pulmonary embolism among men taking testosterone treatments. Deep vein clots usually occur in the legs. A pulmonary embolism occurs if a clot travels to the lungs. Clots in the lungs can be deadly. Testosterone products already warn about a risk of clots in veins caused by polycythemia. This is an abnormal rise in the number of blood cells. But the more recent cases cited by the FDA were not related to polycythemia. The FDA also continues to investigate whether men taking testosterone products may have an increased risk of heart attack, stroke and death. Announced in February, this investigation was prompted by a research study that suggested a higher risk. The new warning is not related to the other investigation. HealthDay News wrote about the announcement.
By Howard LeWine, M.D.
Harvard Medical School
What Is the Doctor's Reaction?
Testosterone treatment is more popular than ever. Worldwide sales are expected to reach $5 billion by 2017. Advertisements for the male hormone suggest it may be just what a man needs to boost his energy, mood and sex drive.
Testosterone is made in the testicles. After age 30, a man's testosterone level begins falling about 1% per year. For some men, the decline is faster and steeper. Short-term studies suggest that testosterone treatment can increase bone mass and muscle strength and improve sexual function.
But is testosterone treatment safe? The U.S. Food and Drug Administration (FDA) is actively looking at this question. Based on results of a couple of studies, the agency already had concerns about a potential increased risk of heart attacks and strokes. This is especially a concern for older men and middle-aged men who have other factors that increase their risk. These include smoking, high blood pressure and high cholesterol.
Earlier this year, the FDA issued an alert about this potential risk. The agency advised doctors to discuss the risk with men who are considering testosterone treatment. Men who were already taking testosterone did not need to stop. But if they were concerned they should discuss it with their doctors.
Now reports of another potential life-threatening problem have emerged. Some men using testosterone are developing blood clots in leg veins. This is called deep vein thrombosis.
These blood clots can break off and go the lungs. Doctors call this a pulmonary embolism. When the clots reach the lungs, they cause chest pain and shortness of breath. Large blood clots in the lungs can be deadly.
Now the FDA is requiring drug companies to add a warning on testosterone product labels about the risk of these blood clots.
What Changes Can I Make Now?
Experts are trying to come to grips with which men really need treatment with testosterone.
Men with extremely low levels of testosterone and men with classic symptoms certainly need treatment. Classic symptoms include:
- Low sex drive
- Low sperm count
- Loss of body hair
- Hot flashes
Few men fall into these categories.
Many more men have symptoms that may or may not be related to low testosterone:
- Difficulty concentrating
- Feeling down
- Trouble sleeping
- Lower energy level
- Less "get up and go"
- Decreased muscle mass
- More fat
Most men have at least one of these symptoms as they age. They may also have lower testosterone levels. But many men with these same symptoms will have normal levels.
Even if the testosterone level is low, it's important to consider whether some of these symptoms might be related to something else. Depression, low thyroid function and other medical problems are possible causes. If other causes are ruled out, the decision to start testosterone treatment for a low level is a personal one. The man must understand the potential risks of heart attack, stroke and blood clots. If he is willing to accept those risks, a trial of testosterone is reasonable.
What Can I Expect Looking to the Future?
In the near future, there won't be any clear answers to the important questions for most men thinking about taking testosterone. We will need more studies looking at both the benefits and safety.