Testosterone Booster Overuse Concerns Endocrine Society

Amid mounting concerns about the safety of popular testosterone boosting drugs, such as AndroGel, Testim and others, the Endocrine Society is warning doctors that the hormone treatments should only be prescribed to men suffering from provable cases of hypogonadism. 

In a statement and new clinical guidelines issued recently, the Endocrine Society suggest that the popular low T drugs should not be as widely used as they have been in recent years.

At a joint hearing of two FDA advisory panels last month on testosterone boosters, the group called for restraint in use of testosterone drugs among men, and in new clinical guidelines released last week in the Journal of Clinical Endocrinology & Metabolism, the group said they should almost never be given to healthy women.

Dr. Ronald Swerdloff, professor at the David Geffen School of Medicine at UCLA, warned the FDA advisors that only men who meet the clinical definition of hypogonadism, including those suffering from testicular or glandular injuries or diseases, should be prescribed testosterone drugs. They also called for more studies into the cardiovascular and prostate side effects of testosterone boosters like AndroGel, Axiron and Testim.

“The Endocrine Society also recommends that more data be collected on men of different ages to better establish the serum testosterone thresholds for specific organ-related symptoms and signs, and to determine which clinical manifestations will benefit from replacement testosterone therapy,” Swerdloff told the FDA’s Bone, Reproductive and Urologic Drugs Advisory and Drug Safety and Risk Management Advisory Committees.

In two 20-to-1 votes, the two advisory committees agreed with the Endocrine Society’s recommendations, calling for the FDA to require drug makers to conduct the studies and for label changes to testosterone boosters that clarifies that their use should be restricted to men with hypogonadism and not given to men just showing signs of lower testosterone due to aging.

The FDA called for the hearing and asked the panels to review available data on the potential heart risks of testosterone replacement therapy, and to recommend what the FDA should do to prevent testosterone drug overuse. The panels’ recommendations are not binding, but often have a strong effect on the agency’s regulatory decisions.

Group Says Low T Drugs Should Not Be Given To Women

In new clinical guidelines issued on October 3, the Endocrine Society also warned that healthy women should never be given testosterone therapy.

“Although limited research suggests testosterone therapy in menopausal women may be linked to improved sexual function, there are too many unanswered questions to justify prescribing testosterone therapy to otherwise healthy women,” Dr. Margaret Wierman, vice president of The Endocrine Society’s Clinical Science and a professor at the University of Colorado, said in a press release. “When we reviewed past studies, we found many women who had low testosterone levels measured by older or new techniques did not exhibit any signs or symptoms of concern. As a result, physicians cannot make a diagnosis of androgen deficiency in women.”

The only time the drugs should be considered for women is if they are diagnosed with Hypoactive Sexual Desire Disorder (HSDD) that is causing personal distress. Even then, testosterone use should start on a three-to-six month trial to see if the drugs are improving sexual function.

Testosterone Drug Lawsuits

The concerns about the safety of the popular medications have caused hundreds of men throughout the U.S. to pursue Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone booster lawsuits against manufacturers of these medications, alleging that information about the potential heart risks was withheld from consumers and the medical community.

Most of the complaints have come following a study published in the Journal of the American Medical Association in November 2013, which found that the side effects of testosterone drugs may increase the risk of heart problems for older men after a coronary angiography, due to plaque build-up in the arteries.

A couple months later, in January 2014, another study published in PLOSOne determined that low T treatments may double the risk of heart attack for younger men with heart disease and all men over the age of 65, regardless of their prior heart conditions.

Just days after that study, the FDA launched its own investigation and announced that it would convene the advisory panels that met this week to further evaluate the risks.

Lawsuits have been filed on behalf of men who allege that side effects of the drugs caused them to suffer heart attacks, strokes, blood clots and other life-threatening injuries.

As the number of complaints filed in U.S. District Courts nationwide has continued to grow, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases last month, centralizing all testosterone litigation before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.