The Simmons Firm Reacts to FDA's Latest Warnings About Testosterone Treatments and Blood Clots

FDA now requires general product label warnings about increased risk

Jun 24, 2014, 08:00 ET from Simmons Browder Gianaris Angelides & Barnerd LLC

ALTON, Ill., June 24, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) announced late last week there has been another risk linked to testosterone treatments. The FDA now requires manufacturers of testosterone or low-T products to add a general label warning about the increased risk for blood clots in veins to their prescription testosterone treatments. Blood clots in the veins, also known as venous thromboembolism, include deep vein thrombosis and pulmonary embolism.

The Simmons Firm has been investigating claims that testosterone therapy can cause blood clots like deep vein thrombosis and pulmonary embolism in addition to other serious injuries including heart attacks and strokes. The firm filed the first testosterone therapy lawsuits on behalf of men injured earlier this year.

"Earlier studies have shown that testosterone treatments increase risk of heart attack and stroke in men," said Trent Miracle, Simmons Firm Shareholder and lead attorney on the case. "This latest warning label requirement by the FDA for blood clots is another indication that taking testosterone treatments for low T is not as safe as men were led to believe."

Current testosterone product labels include language about venous blood clots, but only as a possible consequence of polycythemia, an abnormal increase in red blood cells, according to the FDA. However, the FDA has received post-market reports of venous blood clots with no connection to polycythemia. As a result, the FDA is requiring testosterone manufacturers to provide a more general warning regarding venous blood clots for all FDA approved testosterone treatments.

"Including the warning about blood clots will help men make informed decisions about their health management," Miracle said. "Unfortunately, updated testosterone therapy warning labels come too late for those who have already been seriously injured while taking testosterone treatments."  

About Simmons Browder Gianaris Angelides & Barnerd LLC:
The Simmons Firm is a national leader in pharmaceutical legal matters. Headquartered in Alton, Ill., with offices in Illinois, Missouri and California, the firm has represented thousands of patients and families affected by dangerous drugs throughout the country. The Simmons Firm has pledged nearly $20 million to cancer research. Additionally, the firm focuses on intellectual property litigation, mesothelioma lawsuits, and contingent fee commercial litigation. For more information, visit

Contact: Mark Motley
Simmons Browder Gianaris Angelides & Barnerd LLC

SOURCE Simmons Browder Gianaris Angelides & Barnerd LLC