A recently released study shows that the injectable form of low testosterone drugs do not increase the risk of a heart attack in older men. The study is being touted by companies that make so-called “Low-T” products, but it failed to address the more popular forms of this drug – like gels and pills – and the outcomes among younger men.
The study, published in the July 2014 issue of the Annals of Pharmacotherapy, is contrary to the popular study published in PLoS One. That showed Low T drugs more than double the risk of heart attack in some older men and triple the risk in some younger men.
Instead, the new study reported that injectable testosterone therapy might have some health benefits, including a lower rate of heart attack in some men. The research addressed a narrow portion of the population, men ages 66 and older who received at least one injection between 1997 and 2005. It did not address other forms of testosterone replacement therapy (TRT) for the condition known as Low T.
“Our findings did not show an increased risk of heart attack associated with testosterone used in older men,” study author Jacques Baillargeon of the University of Texas Medical Branch at Galveston said in a published report. “However, large-scale, randomized clinical trials will provide more definitive evidence regarding these risks in the coming years.”
Researchers used enrollment and claims data from 25,420 Medicare patients. The researchers found that testosterone users with a higher risk of heart problems had a lower rate of heart attacks compared to similar patients who did not use Low T drugs. The PLoS One study looked at 55,000 Low T users.
Critics: No Proven Benefit of Low T Therapy
Also called hypogonadism, Low T is considered a condition with symptoms that include infertility, low libido and fatigue. In the past several years, young and old men have been prescribed Low T to increase stamina and counter the effects of aging. It’s become a $2 billion industry and one that is expected to double within five years.
Critics say Low T therapy has not been proven as beneficial. Dr. Adriane Fugh-Berman of Georgetown University Medical Center said Low T syndrome is “invented by pharmaceutical companies to sell treatment products.”
In January 2014, the study published in the scientific journal PLoS One found that men aged 65 or older using TRT had a doubled risk of heart attack in the first 90 days of treatment. For those younger than 65 with pre-existing heart conditions, the risk tripled.
At the same time, federal regulators stepped in to investigate. In June 2014, the U.S. Food and Drug Administration (FDA) expanded the label on testosterone products, adding a warning about blood clots. This includes the risk of venous thromboembolism, deep vein thrombosis and pulmonary embolism. The FDA said its investigation into the risk of heart attacks, stroke and death is ongoing.
The medications in question include gels, pills, pellets and injections under several brand names. Among them:
Lawsuits vs. Testosterone Manufacturers Continue
Patients continue to file lawsuits against companies that manufacture Low T medications, and recently a Multidistrict Litigation (MDL) was created in Illinois. Defendants include drug makers Abbott, AbbVie, Auxilium Pharmaceuticals, Pfizer and Pharmacia & Upjohn.
In addition to heart attacks, stroke, deep vein thrombosis and pulmonary embolism, complications for which the manufacturers have come under fire, the drug makers are accused of adhering to sketchy marketing practices and improper sales methods.