FDA Warns of Heart, Stroke Risk with Testosterone Products

FDA Warns of Heart, Stroke Risk with Testosterone Products | Pintas & Mullins Law Firm

The FDA just released a Safety Communication regarding products used to treat low testosterone due to aging. After months of speculation, the government has confirmed the increased risk of stroke, heart attack and other serious side effects with these “low T” drugs. Testosterone therapy lawyers at Pintas & Mullins Law Firm detail this new alert and the dangers of T-Therapy.

As men age, testosterone naturally declines just as estrogen naturally declines as women age. Testosterone is a hormone associated with many functions, such as sex drive, bone density, muscle strength and mass, sperm production, fat distribution and red blood cell production.

Companies that make testosterone therapy products – like AndroGel and Axiron – have aggressively marketed these as a fountain of youth for men. More than $80 million was spent on AndroGel advertisements in 2012 alone. And it worked: the same year sales of prescription T-therapy gels topped $2 billion.

In 2014, the FDA announced its investigation into these products after numerous studies showed an increased risk of cardiovascular illness in men taking them. For the first time, the FDA is officially confirming these studies, issuing a warning (found here) to help stop the overprescribing of T-therapies. These drugs are packaged as gels, patches,injections, pellets, and materials applied to the gum or cheek.

T-therapy drugs are traditionally only prescribed to men with serious, diagnosed testosterone conditions such as hypogonadism. The actual benefits and risks of T-therapy for natural testosterone decline are not clear, however. Some of the symptoms of low-T, such as emotional or physical changes and changes in sleep patterns or sexual function, may often be caused by other factors, like depression, thyroid problems, excessive alcohol use, or medication side effects.

Risks of T-therapy Outweigh Benefits for Most

Many consider this FDA action belated; in July 2014 the Canadian government issued a very similar warning on the cardiovascular risks of these products. This was based on researched published in 2013 that found a 30% increased risk of death, heart attack and stroke among men taking testosterone drugs compared to men who did not.

Another study that was funded by the National Institutes of Health found that men over the age of 65 who were taking T-therapy had double the rate of heart attacks as men not taking it. That study analyzed medical outcomes of more than 56,000 men.

In its warnings, the FDA urged doctors to only prescribe T-therapy to men with serious medical necessity. This can include men with hypogonadism, brain or genetic conditions, and patients on chemotherapy. The agency specifically stated that testosterone is being used extensively in men who have low-T “for no apparent reason other than aging,” and that the safety of this use “has not been established.” 

In other words, if you do not have a diagnosed medical condition that causes low testosterone, you do not need low-T treatments. The risk of death, heart attack, and stroke, are simply not worth the cosmetic gains of these drugs. Anyone taking low-T drugs should look out for symptoms of heart attack and stroke, including:

• Slurred speech • Chest pain or tightness • Weakness in one part or side of the body • Shortness of breath or trouble bleeding 
If you or someone you love had to be hospitalized after taking a testosterone therapy, contact our firm immediately. Our team of T-therapy lawyers is currently accepting cases of serious injury and death from these products. We offer free case reviews to injured patients and their families nationwide.