Lawsuits for Testosterone Heart Attacks, Strokes

Amid aggressive advertising designed to encourage men to seek out prescription medications for low testosterone levels, or “Low T”, sales of testosterone replacement treatments have increased substantially over the past decade in the United States.

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Saiontz & Kirk, PA, Attorneys & Lawyers, Baltimore, MD

Although men seek to improve their quality of life, recent research suggests that side effects of testosterone therapy may actually increase the risk of serious and potentially life-threatening health problems for some men, including:

  • Heart Attack
  • Stroke
  • Pulmonary Embolism
  • Deep Vein Thrombosis (DVT)
  • Blood Clots
  • Death

As a result of the manufacturers’ failure to provide adequate warnings about these potential testosterone treatment risks for users and the medical community, financial compensation may be available through a product liability lawsuit. To review a potential case for yourself, a friend or family member, request a free consultation and claim evaluation.

Testosterone Treatment Risks

Testosterone is a hormone that is involved in maintaining male sex drive, sperm production, energy levels and bone health. It is natural for testosterone levels to decrease as men age, typically dropping about 1% per year after the age of 30, with noticeable symptoms appearing between age 48 and 70. However, this is simply part of the natural aging process in most cases.

Prescription medications for testosterone replacement have been sold by a number of different drug makers to help reverse the effects of testosterone deficiency, improving muscle mass, increasing energy levels and improving sexual function.

Among the available treatments for low testosterone levels are medications delivered through a gel, cream, injection, pill or pellet, including:

  • AndroGel
  • AndroDerm
  • Axiron
  • Bio-T Gel
  • Delatestryl
  • Depo-Testosterone
  • Foresta
  • Testim
  • Testopel
  • Striant

Although the Endocrine Society Clinical Practice Guidelines (PDF) on testosterone treatment only recommend prescription of medication following a clinical diagnosis of unequivocally low testosterone levels with consistent symptoms, many men have received the drugs without a real need.

A January 2014 study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism suggests that many men in the U.S. are prescribed testosterone treatments with normal levels or after a single test. However, variations in testosterone levels can be caused by a variety of factors, including weight gain, illness, time of day, sleep quality, diet and other issues.

While testosterone treatments only generated about $324 million in sales in 2002, the market has increased to nearly $2 billion in annual sales by 2012. The sudden spike started after direct-to-consumer advertising involving products like AndroGel, which focused on the marketing term “Low T” to describe any men who experienced generalized symptoms like depression, decreased energy and lack of sexual drive.

According to an August 2013 study published in the Medical Journal of Australia, a multinational survey of prescribing trends involving testosterone drugs showed a “major and progressive increase” in most countries over the 11 year period between 2000 and 2011. It was noted that this increase was seen primarily among older men, and driven by prescriptions for age-related low-testosterone.

Many prescriptions in recent years have been for “lifestyle benefits”, rather than to replace actual testosterone deficits. This is concerning because the increased use comes as a result of the drug makers’ failure to disclose information about the heart risks of testosterone replacement therapy and the failure to conduct sufficient studies on the long-term benefits and risks.

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Testosterone Heart Attack, Stroke Side Effects

There is mounting evidence that indicates some men may face serious and potentially life-threatening cardiovascular risks from testosterone treatments.

A growing number of men throughout the United States are now pursuing testosterone drug lawsuits after suffering a heart attack, stroke or sudden death, alleging that manufacturers failed to provide adequate warnings and information about the risk of potential testosterone heart side effects.

In March 2015, the FDA issued a drug safety communication ordering testosterone drug manufacturers to add new label warnings alerting the medical community that low-t drugs may be linked to an increased risk of heart attacks and strokes. The labels are also required to now carry warnings that testosterone drugs are only approved for use by men suffering from hypogonadism which has been proven through laboratory testing.

The FDA is also requiring testosterone drug manufacturers to conduct new clinical trials to better define the link between testosterone drugs and cardiovascular risks.

The determination came following a number of recent studies and recommendations by the FDA’s own advisory committee.

In a study published in the Journal of the American Medical Association (JAMA) in November 2013, researchers from the Veteran Affairs Eastern Colorado Health Care System found that testosterone therapy may increase the risk of death, heart attack and stroke by 29% among certain men.

Researchers reviewed data involving 8,700 veterans with an average age of 60 who underwent a coronary angiography between 2005 and 2011. The men all had total testosterone levels below 300 ng/dL, which is generally accepted as a Low T level. Among these men, 1,223 received a replacement therapy, including testosterone gel, testosterone patch or testosterone injections.

The rate of myocardial infarctions, stroke and death among men receiving testosterone treatments was 25.7%, compared to a rate of 19.9% among the 7,489 men who did not receive low testosterone therapy.

These findings came after a 2009 study involving older men with a high prevalence of heart disease was stopped early when researchers found a spike in the rate of heart attacks among those taking testosterone replacements.

In January 2014, a follow up study published in the medical journal PLoS One examined the risk of non-fatal heart attacks from testosterone drugs, examining the risk among both older and younger men. For younger men with pre-existing heart disease and men over the age of 65 both with and without prior heart disease, researchers found that Low T drug side effects may double the risk of heart attacks.

Testosterone Treatment Lawyers

Despite information that suggests the drug makers knew or reasonably should have known about the testosterone risks, accurate and complete information was not provided to consumers and the medical community. If proper testosterone heart warnings had been provided, many men may have elected to avoid prescription medications for testosterone replacement therapy.

It has been widely suspected that high levels of androgens promote cardiovascular disease, yet the manufacturers of AndroGel, AndroDerm, Axiron, Testim and other testosterone treatments placed their desire for profits before consumer safety by recklessly marketing these products without sufficient research or warnings.

Potential lawsuits are being reviewed by the testosterone injury lawyers at Saiontz & Kirk, P.A. on behalf of men who have suffered a heart attack, stroke or wrongful death.

All testosterone cases are pursued under a contingency fee agreement, which means that there are never any out-of-pocket expenses to hire our law firm and there are no attorney fees unless a recovery is obtained for a testosterone treatment injury.