Avastin Linked to Heart Failure in Breast Cancer Patients

<"http://www.yourlawyer.com/topics/overview/Avastin-Side-Effects-Lawyers-Lawsuit-Attorney">Avastin can increase the risk of heart failure when it is used to treat women with advanced breast cancer, according to a newly-published study. Last month, the US Food & Drug Administration (FDA) recommended that Avastin’s breast cancer indication be revoked.

This latest Avastin study, conducted by researchers at the Dana Farber Cancer Institute and Harvard Medical School in Boston, involved a meta-analysis of five clinical trials involving more than 3,700 patients. Of patients taking Avastin, 1.6 percent developed heart failure, compared with 0.4 percent of women who got a placebo. The study, published online this week in the Journal of Clinical Oncology, is the first to show Avastin increases the risk of heart failure in breast cancer patients.

Other Avastin side effects were also apparent in the study. High blood pressure was seen in 25 percent to 30 percent of patients taking Avastin, with 5 percent of those developing severe hypertension. And about 4 percent to 5 percent developed blood clots.

“From the heart failure standpoint, Avastin is certainly no worse and in many instances better than some other chemotherapy agents that are used to treat cancer in general or breast cancer in particular,” lead author, Dr. Toni Choueiri, told HealthDay News. “But if you look at totality of data, hypertension, severe hypertension and thromboembolic [blood-clotting] events, there seems to be overall increase in cardiac deaths in these patients. When you take all of that together, it really raises the red flag.”

Avastin, the best selling cancer drug in the world, was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. It was originally approved in 2004 to treat metastatic colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. In 2008, the FDA also approved Avastin as a metastatic breast cancer treatment in combination with a chemotherapy drug called paclitaxel, and in 2009, it was approved to treat kidney cancer, as well as glioblastoma multiforme, an incurable brain cancer.

Avastin is one of the most expensive drugs on the market, costing between $50,000 and $100,000 a year. In fact, many patient advocates have criticized the high cost, because Avastin neither cures cancer nor significantly prolongs life.

When the FDA approved Avastin to treat metastatic breast cancer in 2008, it did so against the recommendation of its advisory panel. Avastin for breast cancer was approved under the FDA’s accelerated approval program, based on initial positive studies. Companies then have to submit additional data to gain full approval. Earlier this year results from four new trials that enrolled more than 3,000 women found no significant reduction in disease progression or death among those who took Avastin along with chemotherapy. In July, after reviewing all available data, an independent FDA advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

The FDA announced last month that it was beginning the process to revoke Avastin’s breast cancer approval, after determining that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh its significant risks. Those risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure, the agency said.

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