New Avastin label warns of potential 'ovarian failure'

While Avastin awaits an FDA decision on its use in breast cancer, it's getting new cautionary language added to its label. Among them: A warning that the Roche drug might interfere with women's fertility. FDA recommended that doctors talk to potential Avastin patients about this risk of "ovarian failure" before they start treatment.

The ovarian failure risk was identified in a clinical trial of 179 women treated for colon cancer, half of whom received Avastin in addition to the Folfox chemo regimen. The other half received chemo alone. Study data showed that 34% of women in the Avastin arm experienced ovarian failure, meaning their ovaries stopped releasing eggs regularly. In the other arm, 2% of patients experienced ovarian failure. About 20% of the women regained their ovarian function after Avastin was stopped.

"Long-term effects of Avastin exposure on fertility are unknown," FDA said in a statement. Roche's U.S. unit Genentech said that it would send doctors and other healthcare professionals a letter about the new labeling.

In addition to the fertility warning, Avastin's new label also flags reports of osteonecrosis of the jaw in patients using the drug. FDA said it isn't clear whether Avastin is actually linked to the condition. The label also updates information about blood clots and bleeding risks.

- read the FDA statement
- see the piece in the San Francisco Business Times
- get more from the Wall Street Journal

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