Low testosterone drugs may cause increased heart attack, stroke risk according to FDA warning

by Charles Miller

The Food and Drug Administration has issued a warning about a potential increased risk of heart attacks and strokes for men who use testosterone products for the treatment of decreased testosterone caused by aging. The agency’s warning about the potentially fatal health risks of drugs used to treat low testosterone (or “Low T”) comes less than a year after the FDA ordered the makers of these products to warn patients about their risk of causing blood clots in the veins.

Over the last several years, sales of low testosterone drugs in the U.S. have soared as drugmakers have increasingly marketed these products to men who experienced falling testosterone levels as they aged.  More than 2.3 million men received prescriptions for testosterone products in 2013 to treat symptoms such as decreased libido, lower muscle mass, fatigue, and depression—a 75% increase from just four years before. About 70% of these patients were men ages 40-64, the primary market for the drug industry’s aggressive marketing of these products.

Some of the most commonly prescribed testosterone drugs include Testim (sold by Endo International), Axiron (sold by Eli Lilly), and Andro Gel, which garnered sales of $934 million for AbbVie in 2014. These testosterone medications can be sold in the form of skin patches, solutions, intramuscular injections, and topical gels. Other pharmaceutical companies, including Antares Pharma, Repros Therapeutics, and Lipocine are also said to be developing their own testosterone therapy treatments.

Cardiovascular Risks of Low T Medications

As the popularity of testosterone products has increase among aging men, scientists have uncovered increasing signs that these products can cause serious and potentially fatal side effects among patients. In 2010, a clinical trial for Low T products found such a high risk of heart attacks and strokes among patients taking testosterone that the trial was halted. In 2014, the FDA issued a warning that the use of low testosterone products could lead to serious blood clots known as venous thromboembolism (VTEs), including deep vein thrombosis (DVT) and pulmonary embolism (PE). In November, a study published in the Journal of the American Medical Association found that men taking testosterone products had a 30% greater chance of heart attack, stroke, or death than men who were not taking these medications.

In addition to warning about the increased health risks of medications for Low T, the FDA also advised doctors that these products should only be prescribed to men whose lower testosterone levels were due to certain medical conditions, not by normal aging. Examples of conditions for which the use of testosterone medications has been approved by the FDA include “failure of the testicles to produce testosterone for reasons such as genetic problems or chemotherapy.”

The FDA’s warning about the cardiovascular side effects of testosterone products comes less than a year after Canadian health authorities issued a similar warning about the dangers of these medications. After Health Canada warned about the possibility of serious and life-threatening cardiovascular problems among men taking medications for Low T, the FDA launched an investigation into the safety of these products that eventually resulted in the recent safety warning.

The FDA advised doctors that Low T drugs should only be prescribed to men with approved medical conditions that have been confirmed by medical tests. Patients who experience chest pain, shortness of breath, trouble breathing, weakness in one part or one side of the body, or slurred speech should seek immediate medical attention, as these symptoms could be a sign of a heart attack, stroke, or blood clots.

Heygood, Orr & Pearson and Pharmaceutical Liability Lawsuits

Far too often, the pharmaceutical industry puts its own profits ahead of the interests of patients, disregarding the safety of individuals who may use their products because of the enormous sales these drugs and medical devices may generate. Many products—including Low T medications—have been aggressively marketed to consumers in “disease awareness” campaigns designed to encourage patients to talk with their doctor about prescribing a certain drug, regardless of whether the patient needs it.

As the enormous sales of Low T products have shown, these “disease awareness” campaigns are extremely effective. However, when the health risks of heavily marketed medications is not fully known by doctors and consumers, these drug company sponsored ad campaigns can lead to enormous health costs for patients.

Since researchers first began to raise concerns about the health risks of Low T medications, numerous patients or their loved ones have filed lawsuits over severe or fatal side effects caused by these medications. If you or a loved one has experienced a heart attack, stroke, blood clots, or other complications from testosterone therapy, the first step to speak with an attorney.

For a free legal consultation and to learn more about filing a lawsuit, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also reach us by following the link to our free case evaluation form on this site, and one of our representatives will get in touch with you as soon as possible.


Case results depend upon a variety of factors unique to each case. Results of other cases do not guarantee or predict a similar result in any future case.

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by Charles Miller

Charles Miller is a licensed attorney and a partner at Heygood, Orr & Pearson. Charles focuses his practice on areas of complex commercial litigation and personal injury litigation.