Going forward testosterone product labels will be required to carry a general warning about the risk of blood clots in the veins. This warning is in addition to current product warnings about the dangers of blot clots for those patients with polycythemia.
The FDA stated it was acting amidst its ongoing cardiovascular risk assessment of testosterone products and on reports of venous blood clots unrelated to polycythemia. This recommendation is unrelated other ongoing investigations and studies related to men taking testosterone products.
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.
Patients are encouraged to discuss testosterone products with their physicians to assure the latest information is available.