According to NBC News, doctors wrote 7.5 million testosterone prescriptions in 2013 – nearly double the number written just six years earlier. Although these treatments are sometimes warranted, they are not without risk. Last year, the U.S. Food & Drug Administration issued a warning indicating testosterone therapy is associated with a heightened risk of potentially lethal blood clotting, known as deep vein thrombosis. There have been assertions that long-term data on the real risks is insufficient.
Recently, the journal Endocrinology published a study indicating testosterone replacement therapy may put men at higher risk of developing prostate cancer. While there are other studies that seem to indicate the risk is minimal, the latest research from scientists at the Department of Pathology at the University of Illinois suggests the potential is substantial. In their research, study authors used a slow-release testosterone implant device on some rats and on others used nothing. Then, they injected some of the rats in both groups with a chemical known to cause cancer.
The results indicated that of the rats that got the testosterone treatment but not the cancer chemical, 18 percent developed prostate cancer. Of the rats that got both the testosterone and the carcinogen, 71 percent developed prostate cancer. Rats that were exposed solely to the carcinogen chemical but not testosterone did not develop cancer.
Researchers made a point to request further study but advised doctors to limit testosterone prescriptions for men who don’t suffer from hypogonadism, especially those simply interested in receiving the drug for reasons related to anti-aging.
Meanwhile, the FDA has halted the early release of a new testosterone treatment “low-T” drug developed by Anares. The issue emerged in a recent clinical trial, when a man receiving the treatment broke out in hives. The drug manufacturer has insisted that reaction was not related to the treatment, but the FDA has rejected that assertion.
Our product liability attorneys find this unsurprising because the FDA has taken a harder look at these treatments over the last year. In addition to the warning on deep vein thrombosis issued last year, a panel of agency advisers in September voted for restriction of such drugs except in cases of certain medical conditions.
The agency cited two prior studies that suggest an increase in cardiovascular incidents (i.e., heart attacks) in men prescribed testosterone. While the agency stopped short of saying medications approved by the agency definitely increased the risk, they advised health care professionals to carefully weigh the risk of the treatment with the potential benefit. The agency also noted the testosterone products approved for general public use were not intended for treatment of men with low testosterone levels and no other associated medical conditions.
Study authors of the previous research indicated the risk was especially high for men over the age of 60.
The Ferraro Law Firm handles claims resulting from defective medical products or dangerous pharmaceuticals. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami and Washington, D.C.
Testosterone Treatment Is a Potent Tumor Promoter for the Rat Prostate, Sept. 23, 2014, By Maarten C. Bosland, Endocrinology
FDA steps in after a patient on Antares’ ‘low-T’ drug breaks out in hives, Jan. 13, 2015, By Damian Garde, FierceBiotech
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