by Crystal Phend, Senior Staff Writer, MedPage Today
June 20, 2014

Testosterone products can cause venous thromboembolism (VTE) even in patients without polycythemia, the FDA warned amidst ongoing cardiovascular risk assessment.

Product labels will be required to carry a general warning about the risk of blood clots in the veins, in addition to the warning about those events as a possible consequence of polycythemia that is already included in the product information.

The agency said it was acting on postmarket reports of venous blood clots unrelated to polycythemia.

The label change wasn’t related to ongoing investigation into arterial clot risk from testosterone products.

That investigation, started earlier this year, was sparked by studies reporting an increased risk of stroke, heart attack, and death among men taking testosterone.

Veterans Affairs data showed a significant 29% increased risk of those events in veteranstaking testosterone; another showed 2.19-fold higher risk of myocardial infarction in older men and 2.90-fold elevated risk in younger men with pre-existing heart disease.

But the studies have been controversial, with corrections and a call for retraction of the VA study.

A subsequent observational analysis by testosterone advocates actually suggested seven-fold lower risk of MI and nine-fold lower risk of stroke among testosterone users compared with the general population.

The FDA said it will also be taking steps to ensure that the venous clot risk is consistently labeled across all approved testosterone products, which include testosterone topical gel, transdermal patches, buccal administration, and injections.

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