FDA Cautions Men Using Testosterone of Increased Risk of Heart Attack and Stroke

Written by: Clarissa Guerrero
Published 06/07/2016
Updated: 06/07/2016

According to information from the FDA, prescription testosterone products should only be used by men with low testosterone levels that are the result of certain medical conditions. They haven't been able to evaluate the safety or benefits of these medications. Because of this, the manufacturers are being required to change their labels to clearly identify what the approved uses of the medication are. Manufacturers are also being required to add information on the labels pertaining to the fact there is an increased chance of suffering from a stroke or heart attack in individuals who are taking testosterone. Men should only be prescribed testosterone if they have low levels that are the direct cause of a medical condition that has been confirmed by lab tests.

Testosterone has been approved by the FDA as a form of replacement therapy for men suffering from low testosterone levels due to problems with the pituitary gland, testicles or brain resulting in male hypogonadism. Common examples of these problems include testicular failure causing an inability to produce testosterone due to genetic problems or damage from an infection or chemotherapy. The FDA has become increasingly aware of the fact that testosterone is being used to relieve symptoms in men with low testosterone for no reason beyond the natural aging process. Safety and benefits from using the product have yet to be established.

Based on evidence from a number of studies and input from experts, the FDA concluded that there is an increased risk of dealing with cardiovascular problems stemming from testosterone usage. The studies have reported an increase in stroke, death and heart attack all stemming from taking testosterone.

Because of the findings, the labels have to be changed for any prescription products to reflect increases in strokes and heart attacks all from taking testosterone. Patients need to be made aware of the different risks involved when they take this medication. Manufacturers also need to conduct clinical trials to address whether more individuals are suffering from strokes and heart attacks or not. If patients have any chest pain, slurred speech, shortness of breath or weakness in your body, they need to seek medical treatment right away.