In response to concerns about testosterone products, two major medical organizations along with the U.S. government have issued statements about the safety of low testosterone treatments.

In March 2015, the Food and Drug Administration (FDA) issued a statement that doctors should only prescribe testosterone products to “men with low testosterone levels caused by certain medical conditions and confirmed with laboratory tests.”

This came in response to concerns that testosterone treatments were being widely prescribed for men who did not even have their testosterone levels tested.

The FDA’s announcement also stated that concerns about heart attack and stroke were potential risks of testosterone treatments. The FDA concluded with a call for patients and healthcare professionals to report any kind of adverse events or possible testosterone product side effects to the FDA immediately.

In response to the FDA’s statement, the American Association of Clinical Endocrinologists and the American College of Endocrinology issued a follow-up statement. The AACE and ACE published their follow-up on testosterone treatments in the peer-reviewed medical journal Endocrine Practice in 2015.

The joint announcement states that there is some conflicting information about testosterone therapy. Hypothetically, some of the changes to the body from testosterone treatments should reduce the risk of heart attack and stroke, specifically that the patient’s body fat percentage typically drops—which should reduce the risk of these problems.

However, the AACE and ACE also state that several studies suggest that testosterone treatments due increase the risk of developing heart attack, stroke, and related problems. The groups advise that doctors “be extra cautious” in treating men with age-related testosterone decreases and avoid treating “frail” patients until the risks are better understood.

The statement concludes that larger, better studies are required to make a more definitive statements and advises physicians to take a very individualized approach to testosterone treatments.

Testosterone Product Lawsuits

However, the makers of low-t treatments like testosterone gels are facing massive product liability lawsuits. These testosterone product lawsuits allege that these drugs dangerously increase the risk of heart attack and stroke by causing changes in blood chemistry that make it easier for blood to form clots inside the body.

Testosterone product lawsuits further allege that the makers of testosterone treatments have aggressively marketed their drugs, leading to many men receiving prescriptions despite having never had their testosterone levels tested. Allegedly, companies produced commercials to drum up attention for “low-T,” or declining testosterone levels associated with the aging process.

So many testosterone product lawsuits have been filed that the legal system has resorted a process called a multidistrict litigation or MDL to handle them. In a multidistrict litigation, the court system organizes similar cases together to help streamline the legal process. In a way, this lets them function like a large testosterone product class action lawsuit.

Since testosterone product lawsuits typically make similar claims and hinge on similar evidence, they are ideal for inclusion in a testosterone treatment MDL.