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Cris Valdueza
6 years ago
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 […]
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.
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
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