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FDA Issues New Label to Warn of Side Effects of Testosterone Drugs

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On June 20, the U.S. Food and Drug Administration (FDA) announced that it would require the manufacturers of testosterone drugs to update the warning label to include blood clots including deep vein thrombosis (DVT) and pulmonary embolism (PE).

Postmarket reports of testosterone drug-related blood clots – meaning those unrelated to polycythemia, which testosterone labels already include – has prompted the agency to require a change to provide a more general and consistent warning regarding blood clots as a testosterone side effect. The FDA advised that the recent testosterone label change is not related to the ongoing investigation involving the potential risks of suffering a heart attack or stroke while taking testosterone.

The agency began its investigation into the side effects of testosterone drugs after a study published in JAMA suggested that men taking testosterone drugs had an increased risk of suffering a stroke, heart attack or sudden death while on testosterone.

Eli Lily, the manufacturer of Axiron, advised that it is updating the warning labels and is asking that testosterone levels be tested prior to prescribing treatment, according to a story by NBC Nightly News. The full list of side effects of testosterone is difficult to determine, because there is not enough long term data on testosterone usage.

The FDA has yet to make a determination regarding the association between testosterone and cardiovascular events.