Treatment with Roche Holding AG's cancer drug Avastin might affect fertility in some women, the
The agency said a new warning about the risk of "ovarian failure" was 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. However, in the U.S., the company is fighting to keep the FDA from revoking the approval for
The FDA and companies routinely revise drug labels when there are new clinical data or side-effects seen in post-marketing event reports.
In a statement, Roche's Genentech unit, which
markets Avastin in the US, said it "takes patient safety very seriously and consistently reports new safety information about our medicines, collected through clinical trials and in the postmarketing setting" to the FDA. The company said it would send health care professionals a letter discussing the new labeling changes.
The information on 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. About half the women received Avastin in addition to chemotherapy. The study showed 34 percent of women receiving Avastin experienced ovarian failure, compared to two percent of patients not receiving Avastin.
Ovarian function returned in about 20 percent of the women after treatment with Avastin was stopped.
"Long-term effects of Avastin exposure on fertility are unknown," FDA said.
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