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Eli Lilly says it Will Expand Testosterone Product Label Warnings to Include More Information on the Risk of Blood Clots

June 30th, 2014 Julie Ann Fidler

Eli Lilly and Co. says it will update product labels for its testosterone products to reflect a broader risk of venous thromboembolism (blood clots in the veins) associated with the drugs.
The company says its testosterone products already carry a warning about the risk of blood clots linked to polycythemia, a condition in which a patient’s red blood cells abnormally increase from testosterone treatment. The U.S. Food and Drug Administration (FDA), however, said it recently received reports of blood clots unassociated with the condition, according to Law360.com.
“Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products,” the FDA said in an announcement obtained by Law360.com.
Eli Lilly now says it will update the U.S. product label and medication guide for its Axiron testosterone drug to include the fresh warnings requested by the FDA, Law360.com reported.
The FDA is currently investigating possible links between testosterone products and heart attack, stroke and death in patients. The health watchdog launched the investigation in January after the publication of two research articles that linked elevated cardiovascular risks in men to the use of testosterone-replacement products, according to Law360.com.
A study published in the November issue of Journal of the American Medical Association looked at thousands of patients and found a 30 percent increase in such risks. Twenty-six percent of the men they studied who were taking testosterone-replacement products had a heart attack, stroke or died. Only 20 percent of men not using the products had the same outcome, Law360.com reported.
PLOS ONE published a study in January that found that men older than 65 who used testosterone replacement doubled their risk of having a heart attack, according to Law360.com.
Testosterone-replacement products are only approved by the FDA for use in men who have severely low or non-existent testosterone caused by an underlying condition like chemotherapy or thyroid problems. Drug makers marketing their products to aging men fearful of losing their “edge” has resulted in increasing numbers of testosterone therapy prescriptions, and thus increasing numbers of injuries and deaths.