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Following continuing concerns about the side effects of testosterone treatments, which have been linked to serious heart risks, new guidelines discourage the unnecessary use of the drugs among men who are seeing a natural drop in testosterone levels associated with the normal aging process, and call for doctors to choose injection methods over transdermal applications, such as the widely marketed AndroGel and similar creams or patches.
The American College of physicians (ACP) published new testosterone treatment guidelines in the Annals of Internal Medicine on January 7, providing clinical recommendations to doctors about how to prescribe the controversial drugs, based on current evidence and science.
Treatments for low testosterone were initially intended as a “niche” treatment, for men who experienced drops in testosterone levels associated with a condition known as hypogonadism. However, amid aggressive drug marketing in recent decades, which encouraged men to talk to their doctors about a non-existing medical condition referred to as “low T”, many men sought the treatments when they were not medically needed, to treat symptoms associated with natural drops in testosterone associated with aging.
From 2001 to 2013, prescriptions for testosterone drugs increased more than 300%, However, following studies that highlighted the potential risk of heart attacks, strokes and blood clots associated with testosterone therapy, the FDA has issued warnings and prescriptions have dropped in recent years.
These latest guidelines were developed by the ACP Clinical Guidelines Committee after a systematic review of the efficacy and safety of testosterone therapy in adult men with age-related low testosterone. They reviewed 38 randomized controlled trials.
While the researchers suggested there were no signs of serious adverse events from testosterone treatment, they cautioned that the evidence had low to moderate certainty for adverse events and the quality of evidence was too low to make any judgment on mortality.
The new guidelines call for doctors to discuss whether to initiate testosterone treatment with men with age-related low testosterone with sexual dysfunction who want to improve their sexual function. Doctors should discuss the potential benefits, risks, costs, and the patient’s preferences.
The guidelines say testosterone therapy should not be initiated in men with age-related low testosterone who only seek to improve energy, vitality, physical function or cognition.
The ACP also recommends doctors re-evaluate patients’ symptoms 12 months after beginning testosterone therapy, and periodically afterward. Testosterone therapy should be discontinued in men with age-related low testosterone and sexual dysfunction if there is no improvement in sexual function.
The guidelines also suggest doctors consider intramuscular treatments, injections, instead of transdermal formulations, which are absorbed through the skin. The ACP said the costs of injections are lower, with the same efficacy and risks as creams, gels and patches.
“The role of testosterone treatment in managing age-related low testosterone is controversial,” the guidelines state. “The U.S. Food and Drug Administration (FDA) requires the pharmaceutical industry to label all testosterone medications to clearly state that their products are approved for use only in persons with low testosterone levels due to known causes.”
In recent years, thousands of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other claims have been filed against manufacturers of testosterone therapy, indicating that they recklessly marketed the drugs and failed to adequately warn about the potential risks. Most manufacturers have reached testosterone settlements to resolve nearly all pending claims.