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Thread: FDA warns of counterfiet Avastin

  1. #1
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    FDA warns of counterfiet Avastin

    http://www.fda.gov/Safety/MedWatch/S.../ucm291968.htm

    [Posted 02/14/2012]

    AUDIENCE: Oncology, Pharmacy, Patient

    ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSPís products.

    BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors' offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

    are labeled with Roche as the manufacturer
    display batch numbers that start with B6010, B6011 or B86017
    The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.


    RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

    Call FDA's Office of Criminal Investigations (OCI) at 800-551-3989,
    Visit OCI's Web site (http://www.accessdata.fda.gov/script...i/contact.cfm1), or
    Email - [email protected]
    Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    Complete and submit the report Online: www.fda.gov/MedWatch/report.htm2
    Download form3 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
    My wife was diagnosed with grade II Oligodendroglioma in November, 2009 at age 49. Started Temodar in January 2010. Stopped Temodar June 2011. Recurrence confirmed July 2013. Temodar again from April 2014 to March 2015. Recurrence in April 2015. Radiation May-June 2015. Recurrence January 2016. Tumor is bi-lateral and multi-focal.

    Partial resection in Feb. 2016. Confirmed progression to oligo 3.

    May 2016 diagnosed with breast cancer. Lumpectomy June 2016. No further treatment recommended for breast cancer, due to priority of brain cancer treatment.

    Emergency resection July 2016. Started dex.

    Started Avastin August 2016.

  2. #2
    Super Moderator Top User
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    Geez louise!

  3. #3
    I'm trying to find a list of facilities where this was distributed. Anyone know? a
    May The Odds Be Ever In Your Favour. Born 1960. Diagnosed 4/2011 with one tumor, LUL, NSCLC. Tumor size 1.1 inches. Thoracic surgery 6/1/2011. No action taken. Eight weeks of radiation and chemo. Carbo and Taxol. Follow up with four rounds of Carbo and Alimta.
    December 2011 CT scan shows all clear.
    April 2012 CT scan shows all clear. July 2012 had several x-rays taken at the chiropractor for shoulder pain. Took them to the onc and nothing suspicious noted. See them again in Oct.
    October didn't work out. Pain in the left shoulder continued to worsen and lymph nodes in the supraclavical swelled so I called the onc and they bumped the regular scan up to September 19 and we went for the results on the 24th. The tumor is back and the spread is extensive. Option 1: Try targeting chemos that may work and then on to clinical trials. These would give me about a year or so if the cancer responds. Option 2: Do no treatment and let nature take its course. This will give me six months give or take. As good as I feel right now, Iím going for door #2 and will continue to live well and enjoy myself until I donít. Iíll keep you posted. Live it up everyone!

    7 months into hospice and palliative care. It has been a very good relationship with the organization as a whole with a minor glitch. April 2013 spent the night at hospice facility, PICC line inserted for morphine drip. I said I wouldnít but, had a hospital bed delivered. Started 10 rounds of palliative radiation to shrink the neck tumor. Busy month for me!

    I've taken a couple of nasty falls this last week. (first of & mid-May) Right on the cancer shoulder. So I have a life alert necklace on me now. I wish I could get my hands on a small scooter!

    There is another node swelling on the other side of my neck. Still small.

    April51's (Jody) daughter posted that her Mother's journey in this world had ended on July 8th 2013.You touched so very many lives. Soar high Jody!

  4. #4
    Super Moderator Top User
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    Quote Originally Posted by april51 View Post
    I'm trying to find a list of facilities where this was distributed. Anyone know? a

    I think they're still investigating. We're on Avastin too.

  5. #5
    The FDA sent out 19 letters to individual doctors. The list is here: http://www.fda.gov/Drugs/DrugSafety/.../ucm291478.htm Most are in southern California.
    Diagnosed with stage 2c papillary serous cystadenoma borderline malignancy of the ovary in 2009. Hysterectomy, omenectomy, appendectomy, debulking.
    - 2010 - laparoscopy showed inoperable recurrence, so started chemo.
    - Frontline chemo - carboplatin and cyclophosphamide, six cycles
    - Additional chemo regimens: Avastin - ten cycles; Weekly Topotecan - 4 cycles.
    - Spring 2012 developed pleural nodules. Topotecan plus Avastin - 1year.
    - April, 2014, had surgery to remove Aspergillus infection from right lung.
    - September, 2015, started on Megace because my tumors are PR positive. Stopped Megace after three months.
    - September, 2016, hospitalized for shortness of breath and back pain.
    - September, 2016, respiratory failure reversed with prednisone. Maintaining on 50 mg Prednisone per day and supplemental O2.
    - October, 2016 left hospital with no supplemental oxygen. Feeling great! Will start tapering off the prednisone Oct. 10.

  6. #6
    Serous2c-thanks so much for posting this info,-I feel bad for anyone that recieved it ,but at least its being stopped and taken care of- at least I for one know my mom wasnt given any.-thanks again big help!
    MOMS Journey
    April06- Emergencysurgery,exploratory,10units blood,largetumor and 10inches of colon removed,temp.colostomy.diagnosed stage IV colon.
    oxyplatin,5fu
    Oct06-radiation,surgery,several lymphs,cervix,1 ovary,fallopian,40% remaining colon,large tumor to adipose tissue,appendix,gallbladder removed.permant colostomy/iliostomy
    oxyplatin,transfusion.
    April 07-xeloda-overdose
    surgery-1/3liver,partial diaphra, removed clipped and questionable spots oblated.
    port-port rejection-port removed 1week.
    picc line,5fu,oxyplatin,camptosar.
    Oct-08-surgery-remaining ovary engulfed in tumor,partial bone scrape.
    transfusion central line TPN 1 month.
    oct-09-surgery tumor ,colon and jejuneum removed.
    xeloda reduced. severe dehydration,heart attack.
    april10-remission-avistan
    oct-10-erbitux,camptosar
    Jan-11-5fu
    mar-11 return to original site-oxyplatin,5fu
    Aug-11-erbitux,camptosar.
    dec-28-blood transfusion
    dec-30-back to chemo erbitux camtosar
    Jan-16 injections neulasta and aranesp
    feb16-transfusion
    feb 21-Tumor found stomach,liver, and liver "hot spots" inflamed lymph in rt ureter in kidney causing obstruction-surgery schedualed Mar 16.
    march 16/12-no more kidney obstruction not lymph ...dehydration is causing blockage, two litters blood for anemia, stomach liver tumor small-med,abalation, 1 hidden tumor deep in muscle mass on side flank(hid from scans) -gone!
    june/15/12-blood transfusion
    starting a regimine of celebrex
    aug/16/12-blood transfusion
    aug/30-12 discontinued celebrex -failure one kidney. needed to see urologist
    sept/10-12-good urologist report one kidney functioning well for now.
    oct/23/12-chemo pill Stivarga(regorafenib)
    Nov/22/12-blood transfusion
    dec/18/12-blood transfusion chemo pill dosage cut back to 1 pill.
    Feb/21/13 neulasta injection
    Feb/22/13-blood transfusion. still taking stivarga.
    mar/20/13-arenespt injection rehydration and magnesium IV
    mar/21/13-acute renal failure-kidney infection
    april/1/13.-recovery from 4 day coma infection cleared/4 units blood/ off stivarga/starting rehab therapy,
    swollen hand no apparent reason black spots in vision off and on. both cleared up.
    may/22/13-home oxycodone for pain shoulder neck arm
    june/1/13 pain subsided off oxy onto aleve
    june/09/13-pain back off aleve on vicodin
    june 10/13-cancer in back/neck- starting radiation for arm neck and shoulder pain.
    june24/13-last day of radiation-on steroids
    july1/13-swollen legs and feet-lasix off steroids still on vicodin and xanax
    july 23/13 vicodin cut in half blood transfusion.
    sept/6/13-off all pain meds since late aug
    scan results fracture in spine mid back
    sept/12/13-spine healing on its own,weaning off steroids, no visible tumors.
    nov/7/13-edema both legs and one arm on lasix since oct.
    nov/21/13- leg edema subsiding still alot in one arm- she is talking but keeps her eyes closed. achy but no major pain. nurse and aide to visit once a week schedualed. having trouble standing.
    nov/24/13-sadly but peacefully moms cancer journey is at an end, she will start her new spiritual journey together hand in hand with dad.

 

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