The U.S. Food and Drug Administration (FDA) is holding a conference beginning September 17 to discuss the potential for changes in drug labeling for testosterone replacement therapy products such as AndroGel and others. The FDA has released documentation prior to that including overviews of recent studies and more.

The developments could prove significant although the researchers that put together position documents have noted that there are potential issues with each of the studies and their findings. That means that even one widely publicized study which reported that men who took testosterone replacement therapies were 30 percent more likely to suffer from a heart attack, stroke or other cardiovascular event has some issues and that further research must be done to ensure the results are valid for the wider poulation.

Regardless of the testosterone product side effects, the FDA has noted that the rate of prescriptions filled has skyrocketed in recent years. The federal agency explained that from 2009 to 2013, sales of testosterone replacement therapy, in terms of kilograms of active ingredients, saw an increase of 65 percent and that between 2010 and 2013 the number of patients who received prescriptions for Axiron, AndroGel or related treatments had nearly doubled to 2.3 million patients.

T-Gel lawsuits filed by men who have suffered from cardiac events while using these therapies have alleged that those numbers are the result of popular Low-T commercials that allege that a reduction in energy or sexual vitality may be the result of hypogonadism or low levels of the hormone testosterone.

Those numbers are particularly problematic given that analysis by the federal agency revealed that one in five patients receiving prescriptions did not have evidence of lab testing. This means that of the 2.3 million patients reported in 2013, more then 400,000 could be at risk for testosterone replacement therapy side effects even though they may have no need for the treatment at all.

The FDA’s movement on the necessity of adding more testosterone drug side effects warnings or increasing education efforts regarding the need for testing for testosterone levels has come relatively quickly. The studies cited with the high adverse event rates was published in 2013, although AndroGel lawsuit lawyers have already begun working on behalf of clients they say suffered as result of the treatment.

In fact, there are so many cases alleging that companies unnecessarily marketed the treatment and did not highlight the need for testing that the Judicial Panel on Multidistrict litigation has centralized t-gel lawsuits in the U.S. District Court in Illinois. They allege that issues like reports of heart attack, stroke or even a blood clot are all related to the testosterone therapy products like Axiron and AndroGel.