Avastin being pulled by FDA

newlife2011
newlife2011 Member Posts: 40
edited March 2014 in Breast Cancer #1
My best friend was given Avastin every week for 4 months. She was diagnosed March 2009 with Stage IV bc metastisized to her bone in 9 different places. (age 39) She was off the study for 9 months before it recurred. This was the headline today on FOX news. With everything she has been through, I feel this information is needed in order for all of you to make informed decisions for your care. She did suffer some of these side affects and now I am worried about additional side affects that we passed off as "hormonal" or lack of. Please take the time to read for your own care and be ready to make some logical, informed decisions for your own treatment plan. My best wishes are with you all.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.htm

Comments

  • carkris
    carkris Member Posts: 4,553 Member
    #2
    so do you agree or
    so do you agree or diasagree? i posted about this on FB, but Michelle pointed out some of the really bad side effects. I just dont want something pulled off the market that could help. I have heard it can be pretty toxic. but for me so was chemo! anyway, I was encouraged to read about the PARP inhibitors that are starting to show positive results esp for triple neg BC. I so want to see a cure for this sigh....
  • newlife2011
    newlife2011 Member Posts: 40
    #3
    carkris said:

    so do you agree or
    so do you agree or diasagree? i posted about this on FB, but Michelle pointed out some of the really bad side effects. I just dont want something pulled off the market that could help. I have heard it can be pretty toxic. but for me so was chemo! anyway, I was encouraged to read about the PARP inhibitors that are starting to show positive results esp for triple neg BC. I so want to see a cure for this sigh....

    So do I...want a cure!
    I don't think my personal opinion would help anyone here. What gets to me is back in September this friend of mine called me while I was in Texas for my son's graduation from the Air Force, I was on the phone with her for two hours....this is not normal for her....she is very strong and granted her hand she has been dealt is a very poor one, she was in hysterics and this is just something she doesnt allow herself to do. She just discovered that another drug she was on was more than likely going to kill her of a different cancer....I would like to know why FDA is allowing you all to be guinea pigs? Not that we should test on animals...but I also would like to know why it is so hard for them (united states) to accept what works for other countries?
    So my opinion? I don't believe we can kill cancer with cancer.
    My friend did suffer the side affects of bloody noses, stomach issues, heart issues, that has landed her in the hospital on several occasions and with her being on seven different meds....it is hard to tell which one would have done it to her, but I cannot believe the combination was any help to her health. She was also told by a "second opinion onc" that she HAD to do radiation. Her percentage of recurrance would drop from 25% down to 1%....he told her she couldnt afford to go without the radiation. Three weeks later she discovered that she had in fact recurred and it was spread all over the bones again and in a few more places than last time along with being even more aggressive than from her first diagnosis. I also worry about her menatally.....: (
  • Michaelynn
    Michaelynn Member Posts: 85 Member
    #4
    Avastin
    Heard on the news today that they will no longer be using Avastin for breast cancer patients as they have found it does not work on breast cancer. They will still be using it for some other cancers can't remember all the ones its still going to be used for but I think one of them was brain cancer. Also said that insurance companies are no longer going to pay for Avastin treatments in breast cancer patients. I feel bad for all the women that had the bad side effects taking it and now to find out it doesn't even work for breast cancer.
  • Megan M
    Megan M Member Posts: 3,000
    #5
    carkris said:

    so do you agree or
    so do you agree or diasagree? i posted about this on FB, but Michelle pointed out some of the really bad side effects. I just dont want something pulled off the market that could help. I have heard it can be pretty toxic. but for me so was chemo! anyway, I was encouraged to read about the PARP inhibitors that are starting to show positive results esp for triple neg BC. I so want to see a cure for this sigh....

    I wish I knew more about
    I wish I knew more about this, so, I could really add something. If it does help, I think it would be awful to pull it off the market.

    I want a cure too carkris! It has to be out there, it just has to be.
  • AMomNETN
    AMomNETN Member Posts: 242
    #6
    Michaelynn said:

    Avastin
    Heard on the news today that they will no longer be using Avastin for breast cancer patients as they have found it does not work on breast cancer. They will still be using it for some other cancers can't remember all the ones its still going to be used for but I think one of them was brain cancer. Also said that insurance companies are no longer going to pay for Avastin treatments in breast cancer patients. I feel bad for all the women that had the bad side effects taking it and now to find out it doesn't even work for breast cancer.

    Avastin
    I"m not sure it was pulled because it didn't work on breast cancer. I think it was that the side effects outweighed the benefit. I personally think we should be given the choice. If I know what the side effects are good and bad then I could make my decision.
  • Angie2U
    Angie2U Member Posts: 2,991
    #7
    AMomNETN said:

    Avastin
    I"m not sure it was pulled because it didn't work on breast cancer. I think it was that the side effects outweighed the benefit. I personally think we should be given the choice. If I know what the side effects are good and bad then I could make my decision.

    From what I have read about
    From what I have read about this, it was taken off the market because of the side effects. Not sure if it should have been pulled or not.
  • VickiSam
    VickiSam Member Posts: 9,079 Member
    #8
    Angie2U said:

    From what I have read about
    From what I have read about this, it was taken off the market because of the side effects. Not sure if it should have been pulled or not.

    I heard and read the same thing a few days ago .. still don't
    have the full story .. just a blurr quick fast paced line about side efforts. What a shame.

    What happens to all those 'Warriors' currently taking medication?
  • carkris
    carkris Member Posts: 4,553 Member
    #9
    VickiSam said:

    I heard and read the same thing a few days ago .. still don't
    have the full story .. just a blurr quick fast paced line about side efforts. What a shame.

    What happens to all those 'Warriors' currently taking medication?

    .FDA moves against


    .FDA moves against Avastin
    12/17/2010 (9:38:54am)Tags: avastin FDA approvalComments: (0)

    Although not unexpected, the FDA's decision this week to remove breast cancer as an indication for the use of Avastin has stimulated a large and loud response. The studies are quite clear and convincing that Avastin does not improve survival for women with Stage IV breast cancer and may cause a number of very serious side effects. There are ongoing clinical trials studying the value of Avastin in the adjuvant setting, and this decision will not impact those studies.

    There are some women with metastatic breast cancer who seemingly are being helped by Avastin. Note the "seemingly" because there is never a way to be certain that someone's doing well is directly related to a single drug rather than other ongoing treatments or factors. These women, however, are understandably outraged and terrified by the FDA's decision. Can their doctors continue to prescribe Avastin to them "off-label"? Yes. But, and this is a big "but", their insurance companies may refuse to pay for it and the cost of this drug is thousands of dollars per month.

    Here is a quote from MedPage and a link to read more:


    FDA Moves to Drop Avastin Breast Cancer Indication


    WASHINGTON -- The FDA has begun the process of removing the breast cancer indication for bevacizumab (Avastin).

    Citing a lack of evidence of safety and effectiveness from four clinical trials, the agency decided that "the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients."

    The decision follows an FDA advisory committee's 12-1 vote in July to recommend removal of the indication for metastatic breast cancer

    At a news briefing to announce the decision, Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, offered a bottom-line assessment about the rationale for seeking to remove the breast cancer indication.

    "None of the four trials showed any survival benefit," said Woodcock. "They did not show that adding Avastin to a variety of chemotherapy regimens prolongs the life of women with metastatic breast cancer, but added many serious side effects."




    http://tinyurl.com/266se7s

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