Why did the FDA change course on this drug, and what should the course of action be for patients who had been taking it for this use?
The agency has provided a Q&A on its Web site answering these and other key questions about its decision.
Here are some key excerpts:
“What are the potential risks of taking Avastin?
Women who take Avastin for metastatic breast cancer risk potentially life-threatening or serious side effects, such as bleeding and hemorrhaging; heart attack or heart failure; severe blood pressure; and the development of perforations in different parts of the body such as the nose, stomach and intestines.”
“When does this labeling change become effective?
The approval for metastatic breast cancer is being withdrawn immediately.”
“What should patients do who are currently being treated with Avastin for their breast cancer?
Patients currently receiving Avastin for breast cancer should speak with their oncologists (cancer physicians) about whether to continue their treatment or explore other treatment options. Oncologists should use their medical judgment when deciding whether their patients should continue using Avastin with the drug paclitaxel, take paclitaxel alone, or consider other treatment options.”
The full text of the FDA’s Q&A is available here.