Testosterone Drug Safety Risks To Be Weighed by FDA Panel

Two panels of outside advisors to the FDA are meeting today and tomorrow to discuss the safety and risks associated with testosterone replacement therapy, including such popular products as AndroGel, Testim and others, which have recently been linked to a potential risk of heart attacks, strokes and sudden death. 

The FDA’s Bone, Reproductive and Urologic Drugs and its Drug Safety and Risk Management advisory committees will look at the science behind testosterone boosting drugs, listen to testimony from a variety of experts and then make recommendations about what regulatory actions may be necessary to protect consumers.

While advisory committee recommendations are not binding on the FDA, such recommendations often have a significant impact on the agency’s final decisions about new warnings, recalls or other steps that drug makers may be required to do.

Testosterone Drug Widely Used

In recent years, drugs claiming to combat low testosterone levels, or “Low T”, have carved out a significant industry, turning what was originally said to be a niche drug that would only be needed by a very small number of men into a billion-dollar business.

Increased use of the drugs has been driven by direct-to-consumer advertisements by the drug makers, which suggest that men may be suffering from “Low T” if they experience any number of symptoms commonly experienced by men as they age, including decreased energy levels, weight gain and lack of sex drive.

The FDA only approved testosterone drugs to treat a condition known as hypogonadism, which is usually caused by testicular disease or an injury or disease affecting the hypothalamus or pituitary glands in the brain.

Many experts have suggested that a growing number of men are being prescribed testosterone drugs for “life-style reasons” or to treat “age-related hypogonadism,” where testosterone levels drop due to the natural effects of getting older.

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 drugs appear to have been diagnosed with hypgonadism, and about 25% did not have their testosterone concentrations tested prior to initiating therapy, according to a report submitted by FDA reviewers prior to the panel meetings.

The use of testosterone replacement therapy 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, leading many to call for the FDA to restrict use of the medications to avoid unnecessary exposure to serious health risks.

Testosterone Heart Risks

Late last year, concerns began to emerge about the link between testosterone and heart attacks, with a study published in November suggesting that certain users may experience higher rates of heart attacks, strokes and death.

In a study published in the Journal of the American Medical Association late last year, researchers found that side effects of testosterone drugs may increase the risk of heart problems for older men following a coronary angiography due to plaque build up in the arteries.

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 FDA reviewers’ report released earlier this month suggested that the current studies had limitations that may make the agency unable to draw firm conclusions about the safety of testosterone drugs, indicating that there may be insufficient evidence of cardiovascular risks.

The advisory committees will review the available data and determine for themselves whether the FDA should take regulatory steps to address the testosterone heart risks. The committees are also expected to make recommendations regarding whether and how testosterone drug prescriptions should be controlled or regulated so that they go to the men who actually need them.

Testosterone Drug Lawsuits

Since the FDA launched the investigation, a growing number of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug 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.