New Warning Issued by FDA on Testosterone Products

The United States Food and Drug Administration has issued a new warning about the potential life-threatening side effects of prescription testosterone treatments. The FDA has informed the manufactures of prescription testosterone treatments for men that a warning needs to be added to the drug label warning patients about a heightened risk of blood clots in the veins after using a prescription testosterone product. Such clots can potentially lead to pulmonary embolisms or deep vein thrombosis.

This new warning comes after the FDA’s January announcement that the FDA was reviewing research to determine whether taking prescription testosterone products posed an increase risk of strokes, heart attacks, and death among men who use the products.

A study released this year and published in PLOS ONE indicates that prescription testosterone may double a man’s risk of suffering a heart attack. The study, which examined the records of more than 55,000 individuals who were users of testosterone treatment, concluded that a heart attack risk in men under 65 doubled during the first three months of testosterone therapy use and in doubled in all users who were over 65 years age.

For more information, contact the Manchin Injury Law Group today at 304-367-1862. Drug manufacturers have to be responsible when their products endanger lives.