Women who were given the drug Herceptin as part of treatment for breast cancer.
Use of the drug has been linked to heart muscle damage, known as cardio toxicity, ventricle problems, and heart failure, which can be fatal.
Trastuzumab, also sold as Herclon
In 2005 the FDA updated Herceptin's labeling to reflect possible side effects.
Herceptin, generic name Trastuzumab, has been linked to significant increases in cardio toxicity and heart problems when used in the treatment of breast cancer in women. The drug, manufactured by Genetech Inc., was approved for use in breast cancer patients in the U.S. While the labeling already includes information about possible side effects including heart problems and ventricle problems, the FDA issued a warning in late 2005 after randomized studies showed a significant increase in heart problems – specifically, cardio toxicity – in patients using Herceptin rather than chemotherapy. Possible effects of the drug include heart damage, or even death.
The study of 2,043 breast cancer patients found that over a three year period there was a significant increase in damage to heart muscle (cardio toxicity) and a significant increase in cumulative cases of heart failure. Herceptin was approved for use in 1998, while the FDA warning to medical professionals was issued in 2005.