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Avastin May Harm Women’s Fertility, FDA Says

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Treatment with Avastin, made by Roche Holding AG, might affect fertility in some women, the agency said.

The Food & Drug Administration (FDA) said a new warning about the risk of “ovarian failure” has been added to Avastin’s label and recommended doctors tell women of child-bearing age before they start treatment about the possibility that Avastin can cause ovaries to stop releasing eggs regularly.

Avastin is approved to treat certain types of lung, brain, kidney, colon and breast cancers, but in the company is fighting to keep the FDA from revoking the approval for breast cancer. The label update announced Tuesday is said to be separate from that pending decision.

The decision to add the warning about ovarian failure came from a clinical trial involving the use of Avastin in a study of 179 women with colon cancer who were all being treated with chemotherapy regimen known as Folfox. Nearly half the women received Avastin in addition to chemotherapy. The study revealed 34 percent of women receiving Avastin experienced ovarian failure, compared to just two percent of patients not receiving Avastin.

Ovarian function returned in about 20 percent of the women after treatment with Avastin was stopped. disclaimer: This article: Avastin May Harm Women’s Fertility, FDA Says was posted on Wednesday, October 5th, 2011 at 7:16 pm at and is filed under Uncategorized.

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