Millions of men across the country have received various forms of testosterone therapy (TT). A new study, however, warns that testosterone gels may double the risk of heart attack for some men. Men aged 65 and older had double the risk of heart attack within 90 days of taking a testosterone gel when compared with non-testosterone users. For younger men with a previous heart attack, testosterone gels increased the risk of a subsequent heart almost tripled within 90 days of starting testosterone gel.
Another danger is that once testosterone therapy starts, you may not be able to stop. Dr. Gregory Broderick told CNN that “[o]nce you start, your body begins shutting down natural production of the hormone, thinking it’s no longer needed.”
Testosterone products are marketed under a number of brand names. Some testosterone treatments include:
A CBS report found that testosterone prescriptions doubled in just four years between 2008 and 2012, due largely to aggressive advertisements from testosterone makers directly targeting men. Testosterone supplements have been approved by the FDA for very specific conditions caused by documented low testosterone levels – or Low T. But, due to aggressive off-label marketing, many men are receiving testosterone replacement therapy without Low T levels and for unapproved uses including fatigue and dimished libido. CBS reported that nearly43% of men receiving testosterone therapy had a normal hormone level.
McClatchy Newspapers reported that the vast, off-label growth of testosterone therapies has been deliberate.
The question for doctors was simple: “When a patient comes in and asks for Viagra, will you first screen for low T?” meaning testosterone.
The pitch… was part of its effort to make its testosterone replacement drug AndroGel “ride (the) coat tails of Viagra.”
But unlike Viagra, AndroGel wasn’t approved by the Food and Drug Administration to treat erectile dysfunction.
Instead, it was approved to treat a relatively specific condition of the sex glands called hypogonadism. According to a significant whistleblower lawsuit, [the drug manufacturer] wanted to boost AndroGel’s sales with an aggressive strategy to push “off-label” – or unapproved – uses of the drug.
“I can’t underscore enough how important off-label sales were,” said John King, a former sales manager for [the drug maker]…. “You can do the math: If we had truly stuck to the FDA approved indication, AndroGel would never have had anywhere near the sales it had.”
– Chris Adams, Off-lable marketing: How testosterone replacement got big
AndroGel has been through a number of corporate owners in the last decade: United Pharmaceuticals… which was bought by Solvay Pharmaceuticals… which was bought by Abbott Laboratories… which spun off the division housing AndroGel into AbbVie, a new biopharmaceutical company composed of Abbott’s former proprietary pharmaceutical business. AndroGel has gained about 50% market share through aggressive advertising and courting prescribing doctors.
Researchers have expressed concern over the off-label prescription of testosterone therapy, noting that a “fall in hormone levels in both men and women is a normal part of aging; it is not necessarily a disease. Making it into a disease may end up causing more harm than good.”
Studies Finds Increased Risk of Heart Attack From Testosterone Therapy
The most recent study – by William D. Finkle and others – was published by Plos One on January 29, 2014. The study looked at more than 55,000 men and examined the rate of heart attack within 90 days of starting testosterone replacement therapy. In men age 65 and older, the risk of heart attack more than doubled. Younger men (less than 65) who had a history of heart disease had their risk of heart attack triple.
Finkle said his study was prompted by a 2010 report in the New England Journal of Medicine. The 2010 study involved a clinical trial of testosterone gel in men over 65 years old that was halted after an increase in heart attacks and other heart issues in the group of participants using the testosterone replacement gel.
And earlier study published in the November 2013 Journal of the American Medical Association (JAMA), found that testosterone therapy resulted in a substantially increased risk for heart attack and stroke in men over 65. The JAMA study involved more than 8,700 men treated in VA health care with a total testosterone level less than 300 ng/dL. More than 1,200 patients examined had been given testosterone therapy. Among the men studied, 19.9% of those without testosterone therapy suffered death, heart attack or stroke. However, 25.7% of those taking testosterone supplements suffered death, heart attack, or stroke, representing a nearly 30% increase in risk-factor.
Largely due to these studies, the FDA has announced an investigation into these potentially deadly side effects.
Potential testosterone complications include:
- Heart Attack
- Pulmonary Embolism (PE)
Testosterone Lawsuits Filed
There have been a number of lawsuits filed involving men who have experienced heart attack or other heart-related events after taking AndroGel. Hundreds of additional lawsuits are expected across the country. The attorneys at Langdon & Emison are currently investigating and evaluating these claims. Contact us for a free evaluation of your case.
- Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men [William Finkle, et al. at Plos One]
- Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels [Rebecca Vigen, et al at Journal of the American Medical Association]
- FDA Will Review Safety of Testosterone Therapy [Kathleen Doheny at Health Day]
- FDA to Investigate Testosterone Risk [Kristina Fiore at MedPage Today]
- Off-label marketing: How testosterone replacement got big [Chris Adams at McClatchy Newspapers]
- The Complex Truth About Low Testosterone [Mark Healy at Men’s Journal]
© Copyright 2014 Brett A. Emison
Brett Emison is currently a partner at Langdon & Emison, a firm dedicated to helping injured victims across the country from their primary office near Kansas City. Mainly focusing on catastrophic injury and death cases as well as complex mass tort and dangerous drug cases, Mr. Emison often deals with automotive defects, automobile crashes, railroad crossing accidents (train accidents), trucking accidents, dangerous and defective drugs, defective medical devices.