Testosterone Heart Risks Require Additional Studies: FDA Advisors

Following two days of meetings by independent advisors to the FDA, concerns about the heart risks with low testosterone treatments continue, with two panels of experts calling on the FDA to require drug makers to conduct additional trials to further evaluate the side effects of testosterone drugs on mens’ hearts. 

In a 20-to-1 vote, two FDA advisory committees voted yesterday to recommend that the manufacturers of popular drugs like Androgel, Testim, Axiron and other low T treatments be forced to do more to look into the potential testosterone heart risks, following a series of studies published earlier this year that raised concerns that certain users of the medications may be more likely to suffer a heart attack, stroke or die.

The recommendation came a day after an identical vote called on the FDA to restrict low T drugs for use by men who have an actual illness or disease that is impacting their testosterone levels, in an attempt to reduce the number of prescriptions given for “life style reasons” to address symptoms associated with natural drops in testosterone experienced by all men as they age.

The FDA Bone Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met on Wednesday and Thursday this week, to review available data on the potential heart risks with testosterone replacement therapy and to make recommendations to the FDA on what regulatory actions should be taken to protect consumers.

While the agency is not required to follow the recommendations issued by advisory panels, the FDA typically relies on the findings in any final regulatory decisions.

Recommended Testosterone Drug Regulatory Actions

On Thursday, the panel was nearly unanimous in its vote to order testosterone manufacturers to conduct more comprehensive clinical trials to determine if concerns over heart attacks are warranted. The panels said that the FDA should threaten companies that do not comply with civil penalties.

The only dissenting vote came from Dr. Abraham Thomas, the division head and Whitehouse Chair in Endocrinology at Henry Ford Medical center in Detroit, Michigan, who actually only voted against the recommendation because he did not believe the studies should be conducted by the manufacturers themselves. Dr. Thomas said that the trials should be conducted by the National Institutes of Health, with the pharmaceutical companies footing part of the bill.

Most members said the studies should be randomized, placebo-controlled clinical trials, which are considered by many to be the gold-standard of drug studies.

The recommendations raise serious questions about why the drug makers did not complete adequate and thorough testing for the impact of testosterone therapy on the heart earlier, as most of the drugs have been on the market for more than 10 years and generate billions a year in sales.

While the medications were initially expected to be a niche treatment for men suffering drops in testosterone associated with hypogonadism or other medical conditions, amid aggressive direct-to-consumer advertisements, the low T drugs are now used by many men who may have no real medical need for the treatments.

In 2010, 1.3 million men had received testosterone prescriptions. Two years later, 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% have not even had their testosterone concentrations tested prior to initiating therapy, according to a report submitted by FDA reviewers prior to the panel meetings.

Concerns continue to mount that the drug makers placed their desire for profits before consumer safety by pushing the expanded use and over-use of the medication while ignoring information that may have suggested a potential link between testosterone and heart problems.

Testosterone Heart Injury Lawsuits

Hundreds of men throughout the U.S. are now pursuing Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug 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.