Herceptin (trastuzumab), a drug used for breast cancer patients, may significantly increase the risk of heart problems, specifically cardiotoxicity, according to a study through the National Surgical Adjuvant Breast and Bowel Project. The drug's manufacturer Genentech, Inc. sent a letter to healthcare professionals updating information of cardiotoxicity. Cardiac toxicity can lead to serious heart problems such as heart failure and even death.. The FDA released the Herceptin letter on its Medwatch website at: [FDA MED WATCH]
On August 31st, the drug manufacturer Genetech and the Food and Drug Administration announced that they had sent a warning to the US medical community based on results of a recent trial involving the popular anti-cancer drug Herceptin. The study showed a "significant" increase in heart problems compared to those receiving other forms of chemotherapy.
The drug's label currently warns about possible adverse cardiac effects, but this recent study was an attempt to quantify the extent of the cardiac risks involved. In the study of 2,043 breast cancer patients, 1,109 of those taking the medication showed significantly higher risk of damage to the heart.
The FDA letter states that "congestive heart failure and cardiac death was observed in patients who received the Herceptin containing regimen" showing an incidence of 4.1 percent, compared to an incidence of .08 percent in patients receiving other forms of therapy.
The FDA released the letter on it's website on the 31st of August.
Genetech spokespeople stated that they do not believe this new information will significantly impact the sale of Herceptin, since they state the cardiac risk was already known and many doctors consider the possible cardiac dangers less important than the life-saving and/or life prolonging benefits of the medication. It is considered one of the most popular forms of Chemotherapy used in the treatment of breast cancer.
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