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Evaluating the Risks


By Julie Suchanek, MBA, MT(ASCP), Metropolitan Medical Laboratory, PLC

Testosterone therapy offers many potential benefits for men such as increased muscle mass, improved memory and concentration, an increased libido, and more energy. In recent years, testosterone therapy has increased in popularity as direct-to-consumer marketing has encouraged men to seek prescription treatment for low testosterone levels (“Low T”) if they are experiencing fatigue, decreased sexual virility, weight gain, or other symptoms common with aging.

In 2012, testosterone treatments reached $1.9 billion in sales. In the United States, more than 432 million testosterone product prescriptions (including refills) were sold in 2013. Annual prescriptions for testosterone increased more than fivefold from 2000-2011.

A Cause for Concern
However, there is growing concern that testosterone drugs are being over-prescribed. On Jan. 31, 2014, the FDA issued a safety announcement which stated that the FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. Furthermore, the FDA is urging professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program.

The Risk of Heart Attack, Stroke, or Death

A study published in November 2013 by the Journal of the American Medical Association (JAMA) reviewed the medical histories of 8,700 U.S. veterans, many with underlying heart problems, and all with low testosterone levels.  The men in this group who had received testosterone therapy had a 30 percent higher risk of stroke, heart attack, and death.

A second study (January 2014, PLoSOne) looked at the medical records of 55,000 men who had been prescribed testosterone.  The study found that men over the age of 65 with no prior heart problems doubled their risk of a heart attack after taking testosterone.

A high level of testosterone can also increase a person’s red blood cell count. This makes the blood “thicker,” and that may then predispose someone to a heart attack, stroke, blood clot, or death.

Some are concerned about repeating the hormone replacement therapy (HRT) “disaster” that previously had occurred with women. Observational studies had suggested that HRT had a range of positive effects on post-menopausal women, such as raising sex drive, lowering cholesterol, and the risk of heart disease. Later, a randomized control trial found that HRT increased the risk of breast cancer, heart attacks, and strokes for women.

According to the medical journal The Lancet Diabetes & Endocrinology, large clinical trials of testosterone are “urgently needed.” Author Professor Stephanie Page states that, “physicians need to discuss with their patients that we simply do not fully understand the risks associated with testosterone use in older men, and use conservative treatment guidelines.”

Dr. Richard Quinton, a consultant endocrinologist in Newcastle, England, states that most hormone treatments “work really well if you’re using them to treat someone who’s deficient in them. But if you start treating people with other problems, then generally they don’t — they pop up with adverse effects.” (BBC News, 27 April 2014)

A blood test is the only way to diagnose a low testosterone level. Before being prescribed testosterone, men should have a baseline testosterone measurement through a blood test that is collected in the morning before eating. Research published last year showed that roughly 25 percent of men hadn’t been tested at all before being prescribed testosterone.

Patients who test low for testosterone should also be tested for luteinizing hormone (LH), follicle stimulating hormone (FSH), and prolactin levels. Ferritin levels should be checked in some cases to exclude hemochromatosis. Other useful tests may include testing for sleep apnea, fasting glucose and lipids, hematocrit, PSA, and bone mineral density testing for osteoporosis.

Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels along with an associated medical condition. Testosterone therapy is most often administered as a gel, patch, or injection.

Positive lifestyle steps can extend overall health and help prevent low testosterone levels in men. These include:

  • Eating a healthy diet
  • Exercising
  • Getting enough sleep
  • Not smoking
  • Managing stress
  • Following your doctor’s plan for any health condition you may have

It is important for men to maintain a healthy weight. In adipose (“fatty”) tissue, in both men and women, testosterone changes into estrogen. Being overweight or obese may contribute to low testosterone levels. If you are overweight, weighing less can benefit your testosterone levels.

If you are currently receiving testosterone therapy, you may wish to discuss the potential increased risk of heart problems with your doctor. Do not stop taking any medication until you have discussed the risks and benefits of doing so with your doctor.

As Metropolitan Medical Laboratory celebrates our 100th year in 2014, your good health continues to be our passion. Metropolitan Medical Laboratory, PLC is one of the largest accredited laboratories in the states of Illinois and Iowa, and has provided this community with quality laboratory services for 100 years. Visit www.metromedlab.com. See Metro’s NEWEST location at the intersection of John Deere Road & 53rd Street in Moline or our location at 5401 44th Avenue Drive, Moline, Illinois 61265. Call 309-736-7370 or Fax 309-736-7344. Hours: Mon.-Fri. 7 a.m.–6 p.m.; Sat. 8 a.m.–noon.

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