Testosterone therapy is used to treat “Low-T” levels in men. In recent years, several studies have shown a correlation between the rise in testosterone replacement therapy and a number of medical conditions. These include heart attacks, strokes, prostate cancer, and ultimately death.

Due to the potential dangers of testosterone therapy, the U.S. Food & Drug Administration (FDA) has issued multiple warnings about when to use therapy. As a result of the serious side effects, many individuals have filed lawsuits against testosterone therapy manufacturers, claiming injury and even fatalities.

Testosterone Safety Concerns

As a naturally produced substance in both men and women, it might seem that testosterone is safe for use. However, as with any drug, hormone, or other naturally occurring substance, testosterone can be very dangerous for some people.

Stroke, Heart Attack, and Death

The biggest risks of testosterone replacement therapy in men are the potential for stroke, heart attack, or even death. In 2013 study published in the Journal of the American Medical Association (JAMA) concluded that testosterone therapy is “associated with increased risk of mortality, MI, or ischemic stroke.”

In January 2014, the FDA issued a safety warning declaring that it was monitoring the risk of these adverse effects. However, as of November 2016, the agency still had not issued any official ruling on the issue, stating that there have been no long-term clinical trials to determine the cardiovascular outcomes of taking testosterone over a prolonged period.

Increased Risk of Prostate Cancer

According to the FDA-approved label, another major risk associated with testosterone replacement therapy is the development of prostate cancer, which is the second highest form of cancer among men after skin cancer. The FDA has warned specifically against prescribing testosterone therapy to those who have or are suspected of having prostate cancer.

However, in recent years some medical reviews have called into question whether this link between testosterone and prostate cancer actually exists. One review from 2015 examined studies published in MedLine over a 25-year period. Their findings “strongly challenge” the FDA’s current ban on testosterone therapy for men who have or may have prostate cancer. However, the authors of the review say that additional studies are needed to confirm their results.

Approved Uses of Testosterone Therapy

The FDA has approved the use of testosterone therapy for those who have primary or hypogonadotropic hypogonadism, a condition usually associated with a malfunction of the hypothalamus and pituitary gland.

It is important to note that the FDA has not approved testosterone replacement therapy for “age-related hypogonadism” – that is, lower levels of testosterone due simply to growing older. Other conditions that could lead to low testosterone levels, such as a result of to taking certain medications, are also not approved by the FDA.

Testosterone Supplements and “Boosters”

Testosterone supplements, also called “boosters,” are sold in many drug stores, convenience stores, and supermarkets. These supplements are very different than testosterone replacement therapy products, which require a prescription. There is no scientific evidence that over-the-counter testosterone supplements are an effective treatment for low testosterone levels, and “natural” testosterone boosters are not evaluated by the FDA from a safety perspective.

According to the Federal Food, Drug, and Cosmetic Act (FDCA), dietary supplements need to have some sort of ingredient, such as a vitamin or mineral, that supplements the diet. Some makers of testosterone boosters have been sanctioned by the FDA for failing to include any dietary ingredients in their supplement, and since testosterone (and other steroids) cannot be considered as a dietary supplement on their own, those companies were found to be in violation of the FDCA.

Additional ResourceList of Testosterone Products
Expand Resource
BrandManufacturerFormatActive Ingredient
AndrodermAllergan SalesPatchTestosterone
AndroidValeant PharmaceuticalsTabletMethyltestosterone
AveedEndo PharmaceuticalsInjectionTestosterone Undecanoate
AxironEli LillySuspensionTestosterone
DelatestrylEndo PharmaceuticalsInjectionTestosterone Enanthate
Depo-TestadiolPharmacia/UpjohnInjectionEstradiol Cypionate, Testosterone Cypionate
Depo-TestosteronePharmacia/UpjohnInjectionTestosterone Cypionate
FortestaEndo PharmaceuticalsGelTestosterone
NatestoAytu Bioscience Inc.GelTestosterone
Oreton / Oreton MethylScheringTabletMethyltestosterone
TestimAuxilium PharmaceuticalsGelTestosterone
Testoderm, Testoderm TTSAlzaFilm (Patch)Testosterone
TestopelAuxilium PharmaceuticalsPelletTestosterone
TestredValeant PharmaceuticalsCapsuleMethyltestosterone
VirilonStar PharmaceuticalsCapsuleMethyltestosterone
VogelxoUpsher-Smith LabsGelTestosterone

Testosterone Lawsuits

Due to the potential dangers of testosterone replacement therapy, many lawsuits have been filed against the makers of testosterone-based products. Given the rise in men looking to treat low testosterone levels over the last decade, there has been a corresponding rise in the number of legal actions being filed against testosterone therapy manufacturers.

To deal with the large number of similar cases, the United States Judicial Panel on Multidistrict Litigation (JPML) has transferred lawsuits against testosterone companies to multidistrict litigation case MDL 2545. Although the JPML initially was hesitant to include all testosterone manufacturers within one MDL, the judges on the panel realized most of the claims being made by these companies are the same (or very similar), making them eligible for consolidation under a single MDL.

MDL 2545 started out with 45 cases, but since then more cases have been transferred to the MDL. As of November 2016, more than 6,500 cases were listed on the website of the Northern District of Illinois, the district overseeing these cases.