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Testosterone Drugs Tied to Increased Risk of Heart Disease

  • June 25, 2014
  • RPh on the Go

testosterone-drug-factsIn 2013, 432 million prescriptions were written for low testosterone treatment solutions. 2.9% of American men aged 40 or older are using prescription treatments, spending $1.6 billion a year on the medications. Some younger men are taking testosterone replacement therapy drugs in an effort to prevent the natural decline in testosterone levels associated with aging.

The U.S. Food and Drug Administration (FDA) approved these testosterone replacement drugs to help treat the natural decline in testosterone levels in males, which typically begins sometime between the ages of 30 and 35. In January 2014, the FDA issued a statement saying they are beginning an investigation because these testosterone replacement therapies are tied to an increased risk of:

  • Stroke
  • Heart attack
  • Death


The FDA decided to open the investigation as a result of two studies that indicate the risk of heart problems in men who take medications to treat low testosterone. Doctors have been prescribing treatments off-label, which they are allowed to do after testing a patient’s testosterone levels. These “off label” treatments allow doctors to prescribe medications to treat conditions other than the one they are marketed to treat. Manufacturers are not allowed to market a drug for off label uses.

A study published in the November 2013 Journal of the American Medical Association (JAMA) examines records of 8,709 U.S. veterans who had low levels of testosterone and had blood vessel imaging to judge their risk of coronary artery disease.1,223 of those men had undergone prescription testosterone replacement therapy. Those men had a 30% higher risk of heart attack, stroke, or death compared to the men who did not receive testosterone treatments.

Another observational study reported an increased risk of heart attack in older men. Those who were aged 65 years or older had double the risk of heart attack within the first three months after the first prescription. The study also found that younger men who already had heart disease had a two to three time increased risk of heart attack within the first three months after the first prescription.

Studies of young men who were using testosterone replacement therapy before receiving a low testosterone diagnosis have an increased risk of potentially severe metabolic and cardiovascular issues such as: diabetes, high cholesterol, and plaque buildup leading to artery blockage. In addition, they have an increased risk of prostate cancer, polycythemia, and pulmonary emboli. Testosterone drugs may also lead to: difficulties with urination, enlarged prostate, reduced sperm count, liver cancer, and liver enzyme abnormalities.

Women who come into contact with men using testosterone replacement therapy may experience: deepening voice, increased body hair, reduction in breast tissue, and abnormal menstruation patterns.

Testosterone therapy is available in many formats, including: gels and creams, transdermal patch, pill, and injection. It’s important to ensure that pharmacists filling a prescription for testosterone therapy understands all of these risks.

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