The U.S. Food and Drug Administration (FDA) just announced that it is investigating increased risks of stroke, heart attack, and death in men who take FDA-approved testosterone products. The agency indicated that it has been monitoring these testosterone therapy risks and is now reassessing the safety issues associated with testosterone products. The agency is basing that re-assessment on two different studies that both suggest increased risks of cardiovascular events among groups of men prescribed testosterone therapy.
The FDA indicated that it issued its alert as it continues to evaluate data from these studies and other available information regarding the side effects of testosterone. The agency also indicated that it intends on releasing its final conclusions and recommendations when it has completed its evaluation.
Testosterone is a critical hormone that is involved in the development of male growth and masculine characteristics. Testosterone replacement therapy products are FDA-approved to be used by men who either lack testosterone levels or who are diagnosed with low testosterone levels along with those who are also diagnosed with a related medical condition.
Examples of related medical conditions include failure of the testicles to produce testosterone due to genetic problems or chemotherapy, for example. Other examples may include problems with the hypothalamus and pituitary, which control testosterone production by the testicles.
No FDA-approved testosterone product is approved for use in men who do not have low testosterone levels and who lack a related medical condition. FDA-approved formulations for hormone replacement therapy for men are delivered in topical gel; transdermal patch; buccal system, in which the medication is applied to the upper gum or inner cheek; and injection.
Testosterone Label Updated to Include Risk of Heart Attack, Stroke and Death
In a safety announcement issued on March 3, 2015, the FDA stated that manufacturers are required to make certain changes to the labeling information on side effects of testosterone. The revised label must warn about testosterone and heart attack risks. The new label must also clarify the approved uses of these products, and clearly state that they are only approved for patients with low testosterone levels due to a medical condition.
The labels must include the possible risk of heart attack, stroke and death, the FDA said. This new requirement is based on evidence from published studies and input from an expert advisory panel. Manufacturers are also required to conduct clinical trials assessing testosterone heart attack risk. Healthcare professionals are advised to inform patients about these risks before starting testosterone therapy. According to the FDA, testosterone patients should seek medical attention if they experience the following symptoms:
- Chest pain
- Shortness of breath or trouble breathing
- Weakness in one part or one side of the body
- Slurred speech
The FDA has not approved testosterone for low levels of testosterone as a result of normal aging, the announcement stated. The only approved use for these products is hypogonadism, which causes low levels of the hormone due to disorders of the testicles, pituitary gland or brain. For instance, a patient may have a genetic condition that prevents the testicles from producing the hormone. Other examples include patients with low levels of testosterone due to extensive damage from chemotherapy or infection, the FDA said. The agency noted the overuse of testosterone, pointing out that it is being used excessively to treat men who have low testosterone due to normal aging. Manufacturers are now required to make this information clear, as the safety of this use has not been established and the effects of testosterone replacement therapy can be dangerous.
Medical Reviews Reveal Issues With Heart Safety When Taking Testosterone Products
The first publication that prompted the FDA to review the cardiovascular risk of testosterone replacement involved an observational study of older men in the U.S. Veteran Affairs (VA) health system. That study was published in the Journal of the American Medical Association (JAMA) in November 2013.
In that study, the men were diagnosed with low serum testosterone and were also undergoing coronary angiography, which is imaging of the heart’s blood vessels, to determine if they were suffering from coronary artery disease. Some men received testosterone treatment and some did not. Generally, the participants were about 60 years of age and many were also diagnosed with underlying cardiovascular disease. The study suggested that a 30 percent increased risk of stroke, heart attack, and death was seen in the group who was prescribed testosterone hormone replacement therapy.
A second observational study reported increased risks of heart attack in older men, as well as in younger men who were diagnosed with pre-existing heart disease, who filled a prescription for male testosterone replacement therapy. The study found a two-fold increase risk for heart attack in men aged 65 years and older in the first 90 days following the first prescription. Among younger men who were under the age of 65 and diagnosed with a pre-existing history of heart disease, the study revealed a two- to three-fold increased risk of heart attack in the first 90 days following the first prescription. Younger men with no history of heart disease who filled a prescription for testosterone did not reveal an increased risk of heart attack.
The FDA indicated that it has not yet concluded that FDA-approved testosterone treatment increases risks for stroke, heart attack, or death and further indicated that patients should not stop taking prescribed testosterone products without first speaking with their health care professionals. As for health care professionals, the FDA recommends they consider the risk-benefit profile of FDA-approved testosterone treatments and the risks of testosterone replacement therapy before prescribing these products to their patients. The agency also recommends that prescribing information on the labels of FDA-approved testosterone products be followed.
Have You Been Harmed Following Testosterone Treatment?
If you believe that you or someone you love has suffered from an adverse reaction associated with a testosterone therapy replacement product such as stroke, heart attack, or death, you may be eligible to receive compensation for those injuries. Fill out our online form or call us, toll-free, at 1-800-YOURLAWYER (1-800-968-7529) for a free case evaluation.