Testosterone

Studies + Science

Hormone levels should always be proportionate to age. Testosterone peaks in the late 20s and early 30s, subsequently dropping about 1-2 percent a year. When measuring testosterone, it's impossible for 65-year-old men to be on par with their 35-year-old counterparts.

Older men dealing with problems related to sexual function, bone density, and physical strength are more likely to seek out testosterone replacements. Testosterone medications are most commonly used by elderly men, though the long-term effects of testosterone therapy on their cardiovascular health is still unknown.

Multiple studies have tracked testosterone risks for these age groups, consistently identifying a number of cardiac dangers.

Public Library of Science

In January 2014, the peer-reviewed journal Public Library of Science (PLoS) published a study that tested the link between testosterone and an increased risk heart attacks, referred to as “acute non-fatal myocardial infarction.”

The study, conducted by the University of California, Los Angeles and the National Cancer Institute, included 56,000 patients. It measured the likelihood of heart attack both before and after beginning testosterone treatments.

Scientists concluded that men older than 65 and younger men with undiagnosed heart disease had double the risk of heart attack after the first 90 days. This study builds on an existing body of research linking testosterone to cardiac dangers.

Journal of the American Medical Association

In November 2013, the Journal of American Medicine (JAMA) published a study that examined 8,709 veterans with low testosterone levels. Researchers analyzed cardiac test results that had been entered into the Veterans Affairs (VA) database between 2005 and 2011.

“Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes,” the study authors wrote.

Testosterone therapy increased the risk of death, heart attack and stroke by an estimated 30 percent in veterans with a history of heart disease.

New England Journal of Medicine

Data published in the New England Journal of Medicine (NEJM) showed men using testosterone have "significantly greater" cardiovascular problems, including heart attacks and strokes.

The NEJM trial, called Testosterone in Older Men with Mobility Limitations (TOM), took place in 2010. The trial was terminated due to a high number of negative cardiovascular events. One man died of a heart attack linked to testosterone.

Researchers found “cardiac disorders; respiratory, thoracic, and mediastinal disorders; and skin and subcutaneous tissue disorders” associated with testosterone use. In addition, researchers identified an increased risk of stroke or cerebrovascular accident (CVA) caused by testosterone gels.

If you’re using low-t treatments, contact a doctor if you experience:

• Chest pain
• Shortness of breath or trouble breathing
• Weakness in one part or one side of the body
• Slurred speech

Regulation Recap

When the Food and Drug Administration (FDA) became aware that “testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the agency launched an investigation.

On September 17, 2014, the Bone, Reproductive and Urologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee met to discuss the fact that testosterone drugs were being prescribed to men between the ages of 40 and 64 years old.

“FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions,” the FDA wrote. “The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”

In 2017, a new oral testosterone therapy was approved by the FDA. On their approval the agency reiterated their stance that this treatment was only approved to treat hypogonadism and “should not be used to treat men with ‘age-related hypogonadism,’ in which testosterone levels decline due to aging.”

On April 8, 2019, the FDA released a slideshow presentation for retesting testosterone for pediatric populations. This retest arose because the treatments had been approved in the 1940s and 50s without undergoing the more rigorous modern approval process. The FDA proposed two different laws that could both request and mandate testosterone companies to conduct new research to adhere to the FDA’s modern standards.

Boxed Warning

The FDA has long questioned whether testosterone labeling “accurately reflects the appropriate indicated population.” In April 2009, the FDA sent safety letters to two manufacturers of topical testosterone gels. After receiving reports of children being exposed to the gel, the agency mandated that AndroGel and Testim include a Black Box Warning on their products.

Labeling Updates

In June 2014, the FDA required manufacturers add a more general warning to testosterone labeling. The FDA required all approved drugs to mention testosterone risks such as blood clots, venous thromboembolism (VTE), deep vein thrombosis (DVT) and pulmonary embolism (PE). The first warning focused solely on polycythemia, an abnormal boost of red blood cells.

In March 2015, the FDA requested that manufacturers update their labeling once again. Although the agency had been investigating the link for over a year, the labeling did not clearly illustrate the possibility of an increased risk of heart attacks and strokes.

Also, the agency ordered all testosterone makers to conduct a detailed clinical trial to understand the cardiovascular risks of low-t drugs better.

On Oct. 25, 2016, the FDA updated testosterone labeling again. The agency linked testosterone to a risk of abuse and dependence. When use is discontinued, men may experience withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia.

Targeted Advertising

Studies have linked testosterone therapy to heart attacks, stroke, blood clots, prostate cancer and early death. Researchers suggest that these side effects are most common for more senior men — the primary demographic for the advertisements.

Pharmaceutical companies spend millions on testosterone advertising, which encouraged people to seek out low-t drugs from their doctors. As a result, testosterone prescriptions quadrupled between 2001 and 2011.

While the Endocrine Society encourages testosterone treatments for men with unmistakably low testosterone levels, the organization’s report shows that a quarter of men who take testosterone did not have their blood tested.

One company, AbbieVie, spent more than $45 million promoting its best-selling drug Androgel in the first six months of 2013. The New York Times reported that drug makers spent $107 million on U.S. advertising in 2013. The figure doesn’t include unbranded campaigns that bring attention to low testosterone without focusing on a particular drug.

“IMS Health says sales of testosterone drugs grew by 90% over five years, reaching $1.9 billion in 2011,” according to Fierce Pharma analysts. “By 2017, the entire testosterone market is expected to hit $5 billion.”

The Next Steps

In 2014, an estimated one in 25 men over the age of 60 took testosterone drugs. While scientists conduct research to gain more knowledge about prescription testosterone, millions of people continue using it every day.

Researchers have linked the rising number of prescriptions to testosterone risks. Some health professionals believe that it’s possible to increase testosterone naturally without potentially dangerous prescriptions

It’s time to recognize the high cost that comes with pharmaceutical testosterone. If you used testosterone treatments and experienced heightened cardiovascular issues, you’re not alone.

Don’t stay stuck in a standstill. Connect with a community of advocates who can help.