Five men are suing Abbott Laboratories and its spinoff company AbbVie Inc., alleging the company hid information that using its testosterone replacement drug AndroGel could increase the risk of heart attacks, strokes and death.

The lawsuits were filed just four days after the Food and Drug Administration (FDA) announced it had launched an investigation into the safety of testosterone supplements. FDA authorities cited the results of two recently published studies that linked AndroGel and other testosterone treatments to significantly higher risk of stroke, heart attack and death as the reason for its probe.

The Plaintiffs are men ranging in age from 50 to 63. Three claim they suffered heart attacks after using AndroGel; one says he had a stroke, and the other says he had a mini-stroke. According to the Plaintiffs, Abbott and AbbVie aggressively marketed the drugs directly to consumers, telling them that natural aging processes in men such as weight gain, diminished libido, and lack of energy, are actually symptoms of “Low T,” and can be treated by using AndroGel.

Testosterone replacement products are prescription-only products designed for men who have low levels of the male hormone. But drug makers began heavily marketing testosterone supplements directly to men, encouraging them to talk with their doctors to see if their symptoms could be due to “Low T.” The advertising campaigns paid off, sending sales of drugs like AndroGel, Testim (manufactured for Auxilium Pharmaceuticals, Inc., by DPT Laboratories, Ltd.) and Axiron (manufactured and distributed by Eli Lilly and Company and Acrux) into the millions.

“What consumers received, however, were not safe drugs, but a product which causes life-threatening problems, including strokes and heart attacks,” according to the complaints. Moreover, the drug companies “purposefully downplayed, understated and outright ignored” those risks in its advertising, the complaints assert.

The short-term benefits of testosterone products were considered favorable; however, the long-term effects were somewhat unknown until last month, when two different studies showed that men who used the products were far more likely to experience cardiovascular problems.

The first study, published in the Journal of the American Medical Association (JAMA) in November 2013, showed that older men who used testosterone supplements for three years were as much as 30 percent more likely to have a heart attack, stroke or die from any cause compared to similar-aged men who did not use the supplements.

The results of a second study, released Jan, 29, 2014, indicated testosterone therapy doubled the risk of heart attack for men older than age 65, and nearly tripled the risk for younger men who had a history of heart disease. The new study was led by researchers at the University of California-Los Angeles and published in PLOS One.

These lawsuits could signal the early stages of a wider legal trend as drug companies continue to aggressively market testosterone treatments to men while the products soar in popularity. Analysts expect testosterone drug prescriptions to triple within the next five years, bringing in annual sales of $5 billion.

For more information, visit our Testosterone Replacement Therapy page.



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