The FDA's black box warning — the agency's strongest mandatory safety communication — was required on all testosterone products in March 2015 following accumulating evidence of venous thromboembolism risk. The warning specifically addresses deep vein thrombosis (DVT) and pulmonary embolism (PE) and instructs prescribers to evaluate patients for VTE risk before initiating TRT.

For TRT litigation purposes, the FDA timeline has dual legal significance: (1) it demonstrates that the cardiovascular danger was real, recognized, and ultimately regulatory-grade serious; and (2) the 2014 Drug Safety Communication may constitute constructive notice to plaintiffs in discovery-rule states — meaning the statute of limitations clock may have begun running in September 2014. If you suffered a TRT-related cardiovascular injury before 2022, time may be critically short.