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Strengthened FDA Warning About Blood Clot Risk with Testosterone Drugs

Jun 23, 2014

The Food and Drug Administration (FDA) has strengthened required warnings about blood clots in men undergoing testosterone-replacement treatment.

Testosterone drugs already carry a warning about blood clots in the veins (venous thromboembolism), as a consequence of a condition called polycythemia, in which a patient’s red blood cells abnormally increase from testosterone treatment. But the FDA has also received reports of blood clots unrelated to polycythemia, according to Law360. Because of these reports, “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’s announcement said.

Eli Lilly and Co. will update the product label and medication guide for its testosterone drug Axiron and AbbVie Inc. is updating the label for Androgel, a topical testosterone treatment, according to Law360.

In January, the FDA launched an investigation into the risk of stroke, heart attack, and death in patients taking testosterone drugs after two research studies found elevated cardiovascular risks in men using testosterone-replacement products. A study in the Journal of the American Medical Association found a 30 percent rise in such risks: 26 percent of men studied who were using testosterone products died, had a heart attack or suffered a stroke, in contrast to a 20 percent rate of such outcomes for men not using testosterone products, Law360 reports.  A study published in PLOS ONE, found that the risk of heart attack doubled in men older than 65 who were using testosterone replacement.

The FDA inquiry has major implications for treatments such as AndroGel and Axiron. According to Law360, AndroGel also carries warnings about possible increased risk of prostate cancer and sleep apnea.

Testosterone replacement is FDA-approved only for men with both “low-T” and an associated medical condition, such as a genetic inability to produce the hormone or a brain disorder that inhibits production. Though testosterone therapy is touted as helping to boost sex drive, increase muscle mass and strengthen bones, men using these medications face risks including breast enlargement, reduced fertility, heart attacks, and, possibly, faster-growing prostate cancer, according to Consumer Reports magazine. Testosterone gels applied to the skin can be transferred to others, exposing partners and children to serious unwanted side effects.

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