FDA Safety Warning about Testosterone
On January 31, 2014, the Food and Drug Administration (FDA) released a statement alerting consumers and prescribers that there may be an increased risk in stroke, heart attack, or death in men who are taking testosterone products. The safety risk is based on two recent clinical studies that showed an increase risk of cardiovascular (heart) events in men using testosterone therapy. The FDA is warning the public while they further evaluate the safety risk.
What is Testosterone?
Testosterone is a hormone that is required for male growth and masculine features. Testosterone is FDA-approved for testosterone replacement in men with delayed puberty or who have hypogonadism, which means low levels of testosterone due to the inability of testicles to produce testosterone. It is also used in people with problems with the hypothalamus and pituitary regions of the brain which control testosterone production. Cancer treatment and genetic problems may also cause low testosterone levels.
What is Testosterone Used for?
Although testosterone has an FDA indication for testosterone replacement in men with hypogonadism, it can also provide several benefits as improvement in sexual function, muscle mass, bone density, mood, cognition, and quality of life. Because of these benefits, testosterone can sometimes be used off-label for sexual dysfunction, weight loss, osteoporosis (condition where bones become fragile), or female-to-male transsexual procedures. These benefits also entice individuals to obtain testosterone products illegally. Testosterone has been abused for sports competitions and body building. The FDA safety warning of an increased risk of cardiovascular events applies to all individuals using testosterone.
FDA-Approved Testosterone Products
The following is a list of FDA-approved testosterone products that can either be applied onto the skin (topical gel and transdermal patch), applied to the gum or inner cheek (buccal system), or injected.
Clinical Studies Showing Risk of Heart Related Side Effects
The first clinical study was published in November 2013 and assessed the effect of testosterone therapy on cardiovascular events such as heart attack and stroke. The subjects included in the observational study were 8,709 male veterans with an average age of 60. They had low levels of testosterone and underwent a coronary angiography (a test used to look inside coronary arteries). All subjects had risk factors for heart disease such as diabetes, high cholesterol, and high blood pressure. Of 1,223 men who received testosterone therapy, 67 died, 33 had strokes, and 23 had heart attacks. Among 7,486 men who did not receive testosterone therapy, 681 died, 486 had strokes, and 420 had heart attacks. The study found that testosterone use was associated with a 30% increase in risk of stroke, heart attack, and death.
The second clinical study was published in January 2014 and evaluated an association between testosterone therapy and cardiovascular disease in both older and younger men. The subjects were observed for 90 days after the initial prescription of testosterone therapy. In men aged 65 years and older, there was a two-fold increase for heart attack. In men with pre-existing diagnosed heart disease who were less than 65 years old, a two-to-three-fold increase was reported. However, younger men without a history of heart disease were not associated with having an increased risk of heart attack.
Are there Alternatives to Testosterone?
There may be alternatives for patients who are concerned about using testosterone. Low-dose clomiphene citrate (Clomid) at 25 mg daily can stimulate the pituitary and testicular function. However, the AACE Hypogonadism Guidelines do not recommend its use due to mixed clinical trial results on its efficacy. For males with delayed puberty, human chorionic gonadotropin (hCG) injections can promote testicular growth and development. In men who have sexual dysfunction, phosphodiesterase (PDE5) inhibitors such as Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil) can be used instead of testosterone. Supplements to boost testosterone levels may also be used such as DHEA (a naturally produced hormone that is a precursor to other hormones like testosterone) and L-arginine (an amino acid that helps release hormones). However, it is important for patients to talk with their health care providers to determine if alternative treatments are appropriate.
Consumers taking testosterone for medically sound reasons under the supervision of a doctor should speak with their healthcare providers to evaluate their treatment, risks, and best options for their condition. The studies mentioned are observational studies and they are not proof of cause and effect. The FDA has not concluded that approved testosterone products cause heart attacks and strokes when used appropriately.
Those abusing testosterone products for body building, sexual enhancements, weight loss, or obtaining them illegally on the internet should consider the risks versus benefit of their actions and stop abusing testosterone.
The FDA is further evaluating and has not concluded whether FDA-approved testosterone products increase the risk of stroke, heart attack, or death. Patients taking testosterone products should discuss any concerns they may have with their health care providers first before stopping their use. It is important to weigh the benefits against the risks to determine whether testosterone treatment should be started, continued, or stopped. Health care providers and patients who experience side effects to testosterone products should report them to the FDA MedWatch program.
American Association of Clinical Endocrinologists. (2002). Medical guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients. Endocrine Practice. 8(6): 439-456.
Bassil, N., Alkaade, S., & Morley, J.E. (2009). The benefits and risks of testosterone replacement therapy: a review. Therapeutics and Clinical Risk Management. 5: 427-448.
Finkle, W.D., Greenland, S., Ridgeway, G.K., et al. (2014). Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. Public Library of Science. 9(1): e85805. doi:10.1371/journal.pone.0085805
U.S. Food and Drug Administration. (2014). FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products.
Vigen R., O’Donnell, C.I., Baron, A.E., et al. (2013). Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 310(17):1829-1836.
The material on this site is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider.
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