Product News and Recalls

FDA Announces Risk of Cardiovascular Events from Testosterone Therapy Products

On January 31, 2014, the FDA issued a Drug Safety Communication in which it warned of a potential link between testosterone products and cardiovascular problems. Based on two recently published studies that suggest a link between testosterone therapies and increased risk of cardiovascular events, the FDA has decided to reassess whether this form of therapy is safe. This represents an important determination, because an adverse decision from the FDA could pave the way for testosterone therapy lawsuits.

Testosterone therapy is approved by the FDA for men who have low levels of testosterone, or none at all. However, testosterone therapy has been linked to cardiovascular problems, including stroke, heart attack, and death. One important study was published by the American Medical Association in the November 2013 edition of its journal. Based on an analysis of older men in the Veterans Affairs system, researchers found a 29% increased risk of heart attack, stroke, or death in men given testosterone.

The FDA is warning patients that they should not stop taking testosterone products without first consulting with their physicians. It is important to make sure that all side effects and adverse events—such as strokes, heart attacks, and deaths—be reported to the FDA for the purpose of its assessment.