Low Testosterone

New Low Testosterone Blood Clot Drug Warning Labels Announced by FDA

low testosterone drug warning labels

On June 19, 2014, U.S. Food and Drug Administration (FDA) issued a low testosterone warning. The statement said that new low testosterone drug warning labels will inform consumers about potential blood clot risks.

Drug Warning Labels Updated to List Blood Clot Risks for Men’s Legs

The Boston Globe noted that these blood clots can lead to serious cardiac events, including:

  • stroke
  • heart attack
  • deep vein thrombosis
  • pulmonary embolism

Prior to this, the organization warned that blood clots could occur in men with heart health issues. This also affects men who develop polycythemia (an abnormal rise in red blood cell count). Since then, the FDA received many reports that clots can also occur in men without this complication.

“The 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 a statement.

Additionally, the FDA says physicians “should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment.”

Low Testosterone Drug Warning Labels Previously Updated for Cardiac Event Risks

Prior to the latest FDA safety communication, the agency updated low testosterone drug warning labels in January 2014. These January updates to drug warning labels focused on the increased risk for stroke, heart attack and death.

Hundreds of men around the U.S. are now filing low testosterone lawsuits against product manufacturers. Most plaintiffs suffered a stroke, heart attack or other cardiovascular event while taking low testosterone therapy. In many cases, doctors prescribed men low testosterone drugs for off-label uses.

What Men With Low T Injuries Can Do

If you had a cardiovascular event while taking low-t medication, you may be eligible for compensation. To see if you may qualify for a cash settlement, get your free compensation evaluation online now. Once you’ve submitted your information, an experienced low t advocate will contact you to discuss your compensation options and possible next steps.