Credit: Kevin MacKenzie
The US Food and Drug Administration (FDA) is taking additional action to warn the public about the risk of venous thromboembolism (VTE) associated with the use of testosterone products.
The agency is now requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of VTE these products pose.
The risk is already included in the labeling as a possible consequence of polycythemia, which sometimes occurs with testosterone treatment.
But there have been post-market reports of VTE unrelated to polycythemia.
So the FDA has mandated the label change to provide a more general warning and ensure the risk of VTE is described consistently in the labeling of all approved testosterone products.
This new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products.
The agency is currently evaluating the potential risk of these events, which are described in the Drug Safety Communication posted on January 31, 2014.
Testosterone products are FDA-approved for use in men who lack testosterone or have low testosterone levels in conjunction with an associated medical condition.
The FDA is asking healthcare professionals and consumers to report any adverse reactions related to testosterone products to the agency’s MedWatch Safety Information and Adverse Event Reporting program.
