Herceptin Side Effects Injury Lawsuits. On August 31, 2005, the FDA issued a warning about the potential heart problems associated with use of the breast cancer drug Herceptin (Generic: Trastuzumab). A recent study showed that Herceptin, manufactured by Genentech Inc., significantly increases the risk of heart problems. The study confirmed a significant increase in cardio toxicity in patients who were randomized to the Herceptin-containing (group) as compared to patients who received chemotherapy alone.
The label for Herceptin already includes information about possible heart failure and heart ventricle problems. The randomized, late-stage study of 2,043 breast cancer patients found a higher incidence of damage to the heart muscle, known as cardiac toxicity, in the 1,019 patients taking Herceptin. Such damage can lead to heart failure or even death.
Cardiac Death Was Observed In Patients
A statistically significant increase in the 3-year cumulative incidence of congestive heart failure and cardiac death was observed in patients who received the Herceptin-containing regimen (4.1 percent) compared with control (0.8 percent), a letter written by the manufacturer stated.
Genentech sent a letter to doctors in August 2005. The U.S. Food and Drug Administration published the letter on its website at: www.fda.gov/medwatch/safety/2005/HerceptinDDL_0805.FINAL.pdf