Testosterone therapy is used to treat low testosterone (“Low-T”) levels in men, which can cause a number or hormonal problems including emotional problems such as depression, sleep issues, and a decreased sex drive, among other things. In recent years, several studies have shown a correlation between the rise in testosterone replacement therapy and a number of medical conditions, including heart disease, stroke, prostate cancer, and even death.

Due to the potential dangers of testosterone treatment, 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 testosterone lawsuits against drug 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 failure, 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 U.S. Food and Drug Administration (FDA) issued a safety warning declaring that it was monitoring the risk of adverse effects, including stroke and heart attack. A little more than a year later, the agency issued a safety communication reminding health care professionals and the public that testosterone therapy was approved only for use in men who have testosterone deficiency due to genetic problems, testicular malfunction, or damage related to chemotherapy or infection.

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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.

Other Side effects of Testosterone Therapy

Other adverse testosterone side effects include:

  • Oily skin, which can lead to acne
  • Fluid retention, causing weight gain
  • Breast swelling/enlargement
  • High red blood cell counts, which can increased the risk of blood clots
  • Erectile dysfunction
  • Sleep apnea
  • Testicle shrinkage
  • Enlarged prostate (benign prostatic hypertrophy)
  • Infertility
  • Allergic reaction
  • Increased levels of estrogen (estradiol)

Women who come into contact with testosterone therapy products, such as through contact with skin where testosterone gel has been applied, could experience negative side effects as well. These include body hair changes and increased acne, as well as developing typically male characteristics.

Seek medical advice from your doctor if you experience these side effects after starting testosterone therapy, even if they seem mild or unimportant.

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.

Note that while testosterone injections have have been shown to be more effective at increasing levels of the sex hormone in the blood than testosterone gel or testosterone pellets, all forms of testosterone therapy can lead to adverse effects.

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. Nonetheless, these companies often promote the alleged positive effects of their products, including the stoppage of hair loss, an increase in bone density, and an increase in muscle mass.

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.

List of Testosterone Supplements and Boosters

BrandManufacturerFormatActive Ingredient
AndrodermAllergan SalesPatchTestosterone
AndroGelAbbVieGelTestosterone
AndroidValeant PharmaceuticalsTabletMethyltestosterone
AveedEndo PharmaceuticalsInjectionTestosterone Undecanoate
AxironEli LillySuspensionTestosterone
DelatestrylEndo PharmaceuticalsInjectionTestosterone Enanthate
Depo-TestadiolPharmacia/UpjohnInjectionEstradiol Cypionate, Testosterone Cypionate
Depo-TestosteronePharmacia/UpjohnInjectionTestosterone Cypionate
FortestaEndo PharmaceuticalsGelTestosterone
MetandrenNovartisTabletMethyltestosterone
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 testosterone lawsuits 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 June 2018, more than 7,700 cases were listed on the website of the Northern District of Illinois, the district overseeing these cases.

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