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New Study Reveals Testosterone Drug Risk

Testosterone Replacement Patient

Recent studies have provided conflicting and controversial results regarding testosterone drug risk to patients undergoing testosterone replacement therapy. However, a new report titled “Testosterone Therapy and Risk of Myocardial Infarction: A Pharmacoepidemiologic Study” published on January 13, found statistically significant results.

Researchers Mahyar Etminan, Sean C. Skeldon, Sheldon Larry Goldenberg, Bruce Carleton and James M. Brophy found a statistically significant link between first-time TRT and myocardial infarction (MI). However, a relationship between MI and past or current TRT was not found.

The research team performed a case-control study of 934,283 men aged 45 to 80 from the IMS LifeLink Health Plan Claims Database. Four controls were identified for each case of MI, using density-based sampling. Rate ratios were calculated for past and present TRT users. The risk of developing MI before and after the beginning of a first-time TRT prescription in the same patient was also computed as a sensitivity analysis.

In total, the team identified 30,066 cases of MI and 120,264 corresponding controls. A patient’s current use of testosterone therapy was not linked to a greater risk of MI ─ first-time users did not exhibit an increased risk. No association was found between MI and past TRT users and there were no differences among the different formulations. The rate ratios for current and first-time use of TRT in men with a history of coronary artery disease were 1.05 and 1.78 respectively.

Testosterone drug risk

As men age, many seek TRT to boost their energy levels, sex drive and mood. However, a low testosterone level itself does not require treatment. Testosterone supplements can cause serious side effects and the long-term risks and benefits to patients remain unknown.

Many men who take Low T supplements suffer frequent, but mild side effects including itching, rash or irritation at the spot where the testosterone is applied. However, large clinical trials on the process have not been performed, so experts advise patients to proceed with caution.

Some of the more serious side effects that could result from TRT include:

  • Worsening benign prostatic hypertrophy
  • Stimulating prostate cancer to grow
  • Increasing the risk of deep vein thrombosis and pulmonary embolism
  • Worsening congestive heart failure

FDA investigates testosterone therapy supplements

On January 31, 2014 the U.S. Food and Drug Administration announced it was investigating the risk of heart attack, stroke and death in men taking FDA-approved testosterone products.

“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy,” stated the FDA. “We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete.”

The Agency noted that it has not concluded that FDA-approved testosterone treatment increases the risk of heart attack, stroke or death, but advises healthcare professionals to weigh the benefits of products against the potential risks prior to prescribing. They noted that no FDA-approved testosterone products are approved for use in men with low testosterone levels who have not been diagnosed with an associated medical condition.

  1. Wiley Online Library, Testosterone Therapy and Risk of Myocardial Infarction: A Pharmacoepidemiologic Study
  2. WebMD, Is Testosterone Replacement Therapy Right for You?
  3. U.S. Food and Drug Administration, FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-Approved Testosterone Products