The FDA ( Food and Drug Administration ) is investigating the risk of stroke, myocardial infarction, and death in men taking FDA-approved Testosterone products.
FDA has been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.
FDA is providing this alert while it continues to evaluate the information from these studies and other available data.
FDA will communicate final conclusions and recommendations when the evaluation is complete.
Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.
At this time, FDA has not concluded that FDA-approved Testosterone treatment increases the risk of stroke, myocardial infarction, or death.
Patients should not stop taking prescribed Testosterone products without first discussing any questions or concerns with their health care professionals.
Health care professionals should consider whether the benefits of FDA-approved Testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved Testosterone products should be followed. ( Xagena )
Source: FDA, 2014