Product News and Recalls

New Study Unable to Show Testosterone Does Not Increase CV Risk

controversial study claims no cardiovascular risk with testosterone therapyA new study published in the Mayo Clinic Proceedings purports to show that testosterone therapy does not increase the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE), though the validity of these results may be questionable.

Testosterone therapy products are intended to regulate hormone levels in men with medically confirmed low testosterone. (The drugs are not approved for use in men experiencing the natural testosterone-lowering effects of aging.) Popular “Low-T” drugs include Androgel, Axiron, Fortesta, Striant, and Testim, and it is estimated that more than two million men use these products each year. But testosterone therapy may not be the wonder solution so many men believe it to be.

Several studies before now have linked testosterone therapy to increased risk of cardiovascular problems. A November 2013 study associated testosterone therapy products with increased rates of heart attack, stroke, and death, while another study in 2014 found an increased risk of myocardial infarction in all men using testosterone therapy, especially those 65 years and older.

The new study observed over 30,000 men aged 40 years and older and did not show a statistically significant difference in the rate of venous thromboembolism in those who received testosterone therapy 15, 30, or 60 days before diagnosis.

Yet a careful review of the study indicates that while it failed to confirm the FDA warning in 2014, it has several flaws that make it somewhat uninformative on this issue. For example:

  • The study’s confidence intervals for the risk of DVT or PE overlap with 1.0, meaning it cannot be ruled out that its results were due to chance.
  • Furthermore, the study was not placebo-controlled, which means that there may have been some unmeasured factor that skewed the results. For example, if the men in the study who were less likely to have a blood clot were the ones who received testosterone prescriptions, then the study would fail to detect an increased risk.
  • Similarly, there were apparent imbalances between the two groups (i.e., measured confounders), as indicated in the study: “Controls had a higher prevalence of uncomplicated hypertension, hypothyroidism, diabetes with and without complications, and depression.”
  • Finally, as pointed out on the Mayo Clinic web page, one of the authors has worked with, received funding from, or held stock in multiple big-name pharmaceutical companies, including AndroGel producer AbbVie.

The authors of the study do admit that more research needs to be done on the subject, a sentiment the more than 2,000 men currently involved in testosterone therapy lawsuits likely share. Testosterone therapy lawsuits have been filed as part of a multidistrict litigation in the U.S. District Court for the Northern District of Illinois. The number of testosterone therapy lawsuits is projected to increase significantly as the year progresses.

If you or a loved one was diagnosed with a cardiovascular condition after receiving testosterone therapy, contact Lopez McHugh today to schedule a free legal consultation with a qualified testosterone lawyer. You may be eligible for compensation through your own testosterone therapy lawsuit.