If it’s not one warning, it’s another. So many contraindications, precautions and warnings for each and every medication nowadays that it’s almost impossible to keep up with all the changes! The latest warnings and label changes have now been added to what has been called the best selling cancer drug, that rakes in about $7 billion a year!
Federal regulators are requiring new label warnings for Avastin (Bevacizumab) indicating that the cancer drug may increase the risk of ovarian failure, a rare form of jaw decay, blood clots and excessive bleeding.
The Food and Drug Administration (FDA) announced the new Avastin label warnings on September 30, in the midst of a number of recent concerns surrounding the safety of the medication when used for different purposes.
Avastin is approved to treat certain types of lung, brain, kidney, colon and breast cancers. However, in the US, the company is fighting to keep the FDA from revoking the approval for breast cancer. The label update is separate from that pending decision. Regardless of whether the drug retains its approval for the treatment of breast cancer, it will remain on the market to treat other cancers for which it is approved.
The first of the 3 warnings said that the cancer drug might affect fertility in some women. 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.
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.
The actual FDA label for Avastin now reads, “Avastin increases the risk of ovarian failure and may impair fertility. Inform females of reproductive potential of the risk of ovarian failure prior to starting treatment with Avastin. Long term effects of Avastin exposure on fertility are unknown.”
BUT, as stated, the warnings don’t not stop there!!
According to the statement issued by the FDA, side effects of Avastin may also increase the risk of a rare and debilitating jaw condition, known as osteonecrosis of the jaw (ONJ), which involves the decay and death of the jaw bone, sometimes leading to exposed portions of the bone protruding through the skin. While ONJ has most commonly been associated with the use of bisphosphonate medications, the new label warnings note that some patients on Avastin exhibited the jaw damage when they were not also taking a bisphosphonate.
Avastin has also been linked to increased risk of first time incidents of venous thromboembolic events (VTE), which usually occur in the form of blood clots, but could also cause a pulmonary embolism. In another recent study, 13.5% of cancer patients on Avastin while receiving chemotherapy suffered a VTE, compared to only 9.6% undergoing chemotherapy alone. Researchers also found that when placed on anticoagulants to treat the blood clots, patients on Avastin were more likely to suffer bleeding events.
Sounds to me like I am going to have to make it a point to start paying very careful attention to those little papers that the pharmacy gives me when I am given new medications. All these warnings are frightful! How about you? You think you pay enough attention to those inserts?
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