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Avastin Warning Label to Include Risks of Blood Clot, Ovarian Failure and Jaw Deterioration

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The cancer medication Avastin is linked to a number of adverse events, the FDA says, necessitating a change to the drug’s label.

September 30, 2011 — New warnings were added to the label of bevacizumab, more commonly known as name brand Avastin, after scientific research suggested Avastin patients were at an increased risk of ovarian failure, osteonecrosis of the jaw, blood clots and bleeding in the brain.

The risk of ovarian failure is associated with premenopausal women taking Avastin and receiving chemotherapy simultaneously. The FDA is warning women of childbearing potential to be informed of the increased risk before starting treatment with bevacizumab.

A study of 179 premenopausal women with colorectal cancer — more commonly known as bowel cancer — found new cases of ovarian failure identified in 34 percent of women receiving Avastin in combination with chemotherapy, compared to only 2 percent of women receiving chemotherapy alone. As defined by the FDA, ovarian failure is an absence of a period for three months or more and abnormally high levels of follicle-stimulating hormones, which signal the ovaries to make eggs and estrogen.

Evidence also suggests Avastin patients with metastatic colorectal cancer (mCRC) using anticoagulants are at an increased risk of developing blood clots. Anticoagulants are medications that stop blood from clotting.

A study of over 1401 mCRC patients suggests Avastin patients are at higher risks of a first occurrence of blood clot, as well as subsequent recurring blood clots — also known as venous thromboembolism events (VTE), which are blood clots that occur in a vein.

The chances of an initial blood clot were higher in Avastin-treated patients over patients treated with chemotherapy alone — 13.5 percent versus 9.6 percent. Of the 116 patients treated with anticoagulants following this initial blood clot, patients who were treated with Avastin plus chemotherapy had a higher overall incidence of a recurring VTE event over treatments of chemotherapy alone— 31.5 percent versus 25.6 percent.

What’s more, the occurrence of mild grade 1 bleeding in the brain was higher in the Avastin and anticoagulant combination than the chemotherapy and anticoagulant treatment — 27.4 percent versus 20.9 percent.

Finally, the Avastin label is being updated to include the possible adverse reaction of osteonecrosis of the jaw, which is defined as the death of the bone in the jaw. The condition is marked by pain, swelling, infection and exposed bone.

Marketed by Genentech, Inc., Avastin is a cancer medicine that slows the growth and spread of cancer cells in the body. It is used to treat specific types of brain tumors, as well as cancers of the kidney, lungs, colon and rectum. It is not FDA approved to treat colorectal cancer.

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