FDA Questions Benefits of Testosterone Boosting Medications

Amid concerns about the link between testosterone drugs and heart problems, a panel of FDA advisors is scheduled to meet later this month to determine what regulatory actions should be taken to protect consumers.

In a report (PDF) released in advance of meetings scheduled for September 17, FDA reviewers raised serious questions about whether men with age-related drops in testosterone levels who are being prescribed popular medications like AndroGel, Axiron, Testim and others, actually receive any benefits from the testosterone boosters.

The federal drug agency announced earlier this year that it will ask both its Bone, Reproductive and Urologic Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee to evaluate the available data on potential side effects of testosterone replacement therapy and how to proceed on collecting more information about the heart risks.

FDA reviewers released the briefing paper on August 22, indicating that there may be insufficient evidence at this time to determine whether testosterone boosting drugs carry an increased risk of heart attacks or strokes. However, the report indicates that many men are being prescribed the popular testosterone boosters without any proof that the medications provide benefits for them.

When the FDA first approved low T drugs for the market, it was with the expectation that they would be used only in men who suffered from low testosterone levels due to hypogonadism that is the result of known testicular disease or injury, or hypothalamic or pituitary disease. However, a growing number of men have been prescribed testosterone boosters like AndroGel and Testim for what the FDA calls “age-related hypogonadism”, where testosterone levels drop due to the natural effects of getting older.

“Serum concentrations of testosterone decrease as men age. This decline is usually modest but testosterone concentrations can fall below the lower limit of the normal range for younger, healthy men. This phenomenon is sometimes referred to as ‘andropause’ or ‘age-related hypogonadism’,” the report states. “Furthermore, aging men often experience many of the signs and symptoms that are associated with hypogonadism, including decreases in energy level, sexual function, bone mineral density, muscle mass and strength, and increases in fat mass. Whether these symptoms are a clinical consequence of the age-related decline in endogenous testosterone has not been established, and therefore the need to replace testosterone in these older men remains debatable.”

The FDA found that in 2010, 1.3 million men had received testosterone prescriptions. By 2013, that number had increased to 2.3 million. The largest increase was among men age 40 to 64, jumping from 850,000 in 2010 to 1.5 million by 2013.

Only about half of the men taking testosterone boosters appear to have been diagnosed with hypgonadism, and “25% did not have evidence of having their testosterone concentrations tested prior to initiating therapy,” the report notes.

The use of testosterone replacement therapy, more commonly referred to as “low T” drugs or testosterone boosters, has even expanded in recent years to include a large number of men showing no symptoms of hypogonadism at all, and some with only vague symptoms, such as fatigue and feeling irritable.

“FDA’s analysis revealed that 21% of patients prescribed TRT did not have evidence of laboratory testing for serum testosterone concentrations at any time during TRT treatment, including testing prior to the first TRT prescription,” according to the report. “This is particularly concerning because the diagnosis of hypogonadism requires documented evidence of low or absent serum testosterone concentrations and the appropriate TRT dose cannot be determined without following serum testosterone concentrations on therapy.”

The FDA reviewers said there is no reliable evidence that men with age-related hypogonadism are getting any benefit from these drugs.

Testosterone Booster Heart Attack Risks

The lack of benefit apparently provided by testosterone boosting drugs further increases concerns surrounding the safety of the medications, after several recent studies suggested that certain users of the medications may face an increased risk of heart attacks, strokes or sudden death.

In November 2013, a study published in the Journal of the American Medical Association suggested side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

This research was followed by a study published by the medical journal PLOSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

The FDA launched its own investigation shortly afterwards. However, the new report suggests that the current studies had limitations that may make the agency unable to use them to determine whether there was sufficient evidence of cardiovascular risks.

Testosterone Drug Lawsuits

Since the FDA launched the investigation, a growing number of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone booster lawsuits are now being pursued against the manufacturers of these medications, alleging that potential side effects of the medications were not properly researched and that adequate warnings were withheld from consumers and the medical community about the potential heart risks.

Most of the complaints involve similar allegations, indicating drug makers aggressively promoted testosterone boosting treatments for use among men who had no real medical need. Plaintiffs indicate that use of testosterone drugs caused them to suffer a heart attack, stroke, deep vein thrombosis, pulmonary embolism or other serious injury, including many wrongful death lawsuits.

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.