Testosterone Clinics Springing Up That Prescribe Low-T Drugs for Lifestyle Reasons: Report

Amid recent warnings that popular testosterone drugs should only be prescribed to men with a true medical need, a new report suggests that a number of clinics are opening nationwide, which appear to be giving men Low T drugs for “lifestyle” reasons.

According to a recent story on Fusion.net, lifestyle clinics are opening nationwide, where doctors appear to be giving men drugs like Androgel, Axiron, Testim and others, not because they have confirmed low testosterone levels caused by a medical condition, but because they want to fight the natural effects of aging.

The report suggests that these testosterone clinics are not claiming to heal the sick or cure diseases, but are prescribing testosterone drugs off-label to help older, wealthy men feel younger again.

These uses, however, are exactly the what an FDA advisory panel warned against last September, when it urged the FDA and drug manufacturers to change the labels on testosterone medications to make it clear that low-t drugs should only be given to men suffering from low testosterone caused by hypogonadism from brain or testicular disease or injury.

Both the FDA and the Endocrine Society have issued warnings in recent months, indicating that men should not be prescribed Low T medications for lifestyle reasons, as recent studies have raised concerns about potential side effects of testosterone drugs, indicating that some men may face an increased risk of heart attacks, strokes and sudden death.

Over the past decade, the testosterone drug industry has grown from a niche market to generate about $2 billion a year in sales, driven by aggressive marketing by the drug makers that have encouraged men to talk to their doctors about “low T” if they experience any number of symptoms commonly associated with natural drops in testosterone as all men age, such as decreased sex drive, reduced strength and general lack of energy.

The new testosterone clinics appear to be wellness centers, which are typically not found connected to other hospitals or clinics that might raise the ire of the FDA. They claim to cure no diseases. However, they involve medical doctors, who can prescribe testosterone for patients, who take the drugs as body building and dietary supplements.

Those patients pay in cash, with no medical insurance involved, as it is likely few insurance companies would cover this use of testosterone. However, it is unclear if the men going to these clinics, and often being charged thousands of dollars for drugs they anticipate will increase muscle mass, energy and sexual prowess, are being told about the potential heart risks with testosterone drugs that federal health regulators are currently investigating.

Testosterone Health Risks

Over the past year, a number of studies have linked use of testosterone replacement therapy to serious and potentially life threatening health risks, such as heart attack, stroke, pulmonary embolism, deep vein thrombosis and sudden death.

In addition, many experts and reports have raised concerns about the widespread overuse of testosterone drugs among men, suggesting that most users of the drug have no real medical need for the medications and receive the prescriptions without ever having their testosterone levels tested or after tests show normal levels.

In November 2013, a study published in the Journal of the American Medical Association (JAMA) found that older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events, such as a heart attack, stroke or death.

That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.

Just last month, a study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.

Testosterone Drug Lawsuits

Following the publication of the independent research over the past year, a growing number of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug lawsuits have now been filed in courts throughout the U.S., alleging that manufacturers placed their desire for profits before consumers safety by failing to adequately research the drugs or warn about the potential side effects.

In the federal court system, testosterone lawsuits filed in U.S. District Courts nationwide have been consolidated for pretrial proceedings, discovery and a series of early trial dates. The lawsuits are centralized as part of a federal Multidistrict Litigation (MDL), which is pending before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

The first Androgel trials are expected to begin in late 2016, which may help gauge how juries will respond to certain evidence and testimony that could be repeated throughout thousands of cases nationwide if testosterone settlements or another resolution for the litigation is not reached before then.