The Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee made two recommendations to the agency at a joint meeting held in September.
The panel recommended that the FDA require sponsors of testosterone therapy products to study potential cardiovascular risks to users. It also recommended tightening how the drugs are prescribed and marketed to assure they are not used by men who only have problems related to aging, such as low energy and libido.
The recommendations do not require action, but a FDA spokeswoman said they are being considered.
Testosterone replacement therapy is most frequently prescribed for erectile dysfunction, a complex problem that is most often not attributed to testosterone deficiency, said Robert Eckel, MD, a past president of the American Heart Association, an endocrinologist and an endowed chair of atherosclerosis at the University of Colorado’s medical school.
Many men prescribed testosterone therapy don’t meet the criteria for treatment, unnecessarily exposing them to potential adverse side effects and increased risk for cardiovascular disease.
“Giving testosterone is easy but giving testosterone therapy without documenting testosterone deficiency raises concerns,” Dr. Eckel said.
Several recent studies show an increased risk of heart attack, stroke and death among patients undergoing testosterone therapy have caused the FDA to look more closely at the drug’s risks.
An observational study of men undergoing coronary angiography suggested a 30 percent increased risk of adverse cardiovascular events among patients prescribed testosterone therapy. A second observational study published earlier this year reported a two-fold increase in the risk of myocardial infarction in men over 65 years old in the first 90 days following the first prescription of testosterone therapy, and a two-to-three fold increase in risk for younger men with a preexisting history of heart disease.
But two other observational studies in men with a mean age of 60 years suggested a significant reduction in all-cause mortality associated with TRT therapy.
Approved in the U.S. since the 1950s as replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone, testosterone therapies have moved into a treatment regime for “aging men who have low serum testosterone concentrations for no apparent reason other than age, and who experience nonspecific symptoms of aging that overlap with those of classic hypogonadism (low testosterone),” according to FDA briefing materials on the subject.
The FDA said that it remains unclear whether such symptoms in older men, which can include decreased energy level, sexual function, bone mineral density, muscle mass and strength, and increases in fat mass, actually call for such drug therapy.
In 2013, 2.3 million patients received a prescription for testosterone, up from 1.3 million in 2010, with men age 40 to 64 years, representing 69 percent of the prescriptions, the FDA said.
Dr. Eckel said patients should work with their healthcare providers to better understand whether they are candidates for the drugs. If uncertainty remains, they should consult with an endocrinologist to learn more about the risks.
Trent Miracle, head of pharmaceutical litigation at the Chicago-based Simmons Hanly Conroy, said the recent committee vote goes “a long way to tightening up” uses for testosterone therapy drugs.
“‘Low T’ is an industry created condition to justify the broad use of testosterone across a demographic for which it was never intended or approved,” said Miracle, whose firm represents at least 400 men affected by testosterone replacement therapy.
More than 200 lawsuits have been filed in the U.S., alleging the manufacturers of testosterone replacement therapy drugs increased sales using marketing tactics to convince men such therapy could provide a solution for problems normally associated with aging. The claims also say the companies failed to properly warn doctors and users about the risks and side effects.
Earlier this year, the federal cases were consolidated in the Northern District of Illinois, located in Chicago.
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