The U.S. Food and Drug Administration (FDA) has directed two different committees to evaluate the potential public health risk associated with androgen-based drugs used in testosterone therapy. This comes as the drugs are facing increasing scrutiny, in the form of both public health concerns and testosterone product lawsuits.

The drugs in question are designed to treat men who are low in testosterone, or “low-T.” In males, a family of hormones called androgens, which includes testosterone, govern many traits associated with masculinity. This includes muscle development, libido, and energy.

As men age, testosterone levels decrease. In some males, this decline is more dramatic, and may produce irritability, mood swings, decreased libido, and loss of muscle mass. Low-T drugs are designed to add extra testosterone to compensate for this.

However, testosterone drug lawsuits allege that these drugs may have serious complications, and that drug companies have aggressively over-promoted the drugs in spite of this.

Testosterone drug lawsuits have alleged that low-T drugs like AndroGel and others increase a person’s risk of serious complications. Many of the alleged testosterone product complications center around blood-clot related problems.

Under normal conditions, blood clotting is a natural healing process, and helps stop a person from bleeding to death. However, when this process misfires, it can cause blood clots to form inside the body. These clots can get stuck in important blood vessels, like those that supply the heart, brain, and lungs with blood. This can lead to life threatening testosterone side effects such as a heart attack, a stroke, or a pulmonary embolism.

Several studies have found that low-T drug complications can include these types of emergencies. The FDA committees have been tasked with evaluating these risks and deciding on appropriate actions.

These research studies include a 2013 study published in the Journal of the American Medical Association that found that low-T drugs increased the risk of heart problems in men who had a history of heart disease. Additionally, a 2014 study in PLoS One found that the drugs may double the risk of heart attack — even among men with no history of heart disease. Additionally, some studies have found that as many as a quarter of men who take low-T drugs have never had their testosterone levels checked.

Testosterone drug lawsuits have alleged that in spite of these risks, drug manufacturers have aggressively marketed low-T drugs. Testosterone product lawsuits cite the fact that millions of dollars have been spent promoting these drugs, which have in turn generated billions in revenue.

This is not the first action by the FDA to address the concerns raised by testosterone drug lawsuits. Earlier in 2014, the FDA did consider a black box warning after Public Citizen, a drug safety advocacy group, petitioned the agency. The FDA tabled the motion for the moment, but only until the data could be more thoroughly studied.

Additionally, the FDA has made some labeling changes in light of these concerns, but stopped short of black box warnings, since this is the most severe warning the FDA can make, short or recalling or banning a drug.