Discussion in 'Fibromyalgia Main Forum' started by annepat, Aug 4, 2003.

  1. annepat

    annepat New Member

    This was posted on co-cure.Please read this message in its entirety, and Please bump it up. Thanks-annepat
    1. Injectable Kutapressin 7-03 expired batch lot. If you are or have used Kutapressin, please keep your bottles and boxes, and please check the expiration date and batch lot number listed on the top of the box and the side of the vial-DO NOT RELY ON PHARMACY EXPIRATION DATES, as they may expire months later than the actual product expiration date. A batch lot with the expiration date of 7-03 was in circulation as recently as March/April, but the expiration date the pharmacy label is 4-04. I received a bottle from this batch lot from CVS pharmacy. Their wholesaler distributor is Cardinal Health; Schwarz Pharma distributes the drug to Cardinal Health. That is the chain-Schwarz to Cardinal Health, Cardinal Health to CVS Pharmacy.

    There are 3 wholesaler distributors that are responsible for 90% of the drug wholesale/distribution in the US. They are: AmerisourceBergen (ABC), Cardinal Health (CAH) and McKesson (MCK). Please note that they have been asked by federal officials to provide documents about drug sales, utilization, marketing and promotions dating back to 1998.

    Contact information is listed below.

    2. Injectable Kutapressin formula. I am working with several members of the congressional delegation to force Schwarz to release the formula to an FDA approved undisclosed wholesaler to compounding pharmacies for distribution throughout the United States. According to an FDA contact, it is normally considered "courtesy" for a pharmaceutical company to release the formula under these circumstances. Contact information is listed below. Note that potential safety issues/concerns are emerging; if you have any information that may assist them in these matters, please email them. You may also wish to post your concerns so that others may assist you. I am printing everything and giving it to my physicians. I would strongly encourage everyone to do the same. Please not that your physicians can also email or write to these members of the congressional delegation.

    It would also be helpful to know how many people are on this drug, and the route that the drug took before you received it. For example, do you order your Kutapressin from your health insurer prescription benefits manager, a pharmacy chain, an Internet pharmacy, or some other route? How do your suppliers receive their Kuytapressin?

    3. injectable Kutapressin manufacturing difficulties. Please note that the company continues to be quite vague regarding the nature and extent of the manufacturing problems that halted production of the drug. Note that congressional staff will forward your concerns to the FDA for prompt reply.

    4. Medicare reimbursement for Injectable Kutapressin. In May or June 2003, Medicare ceased reimbursement for Kutapressin; they claim that it is not an FDA approved drug. I have been calling and emailing various departments within the FDA, several Fiscal Intermediaries to Medicare, the HHS Office of the Inspector General, etc. to report my concerns about Schwarz's lack of response regarding the nature and extent of their manufacturing difficulties, their unwillingness to disclose proprietary information, their refusal to work with patients and physicians, and to notify everyone that this is an FDA approved drug. After considerable effort, I finally spoke with Dr. Louis Jacques, Medical Director of the Center for Medicare and Medicaid Services center for Program Integrity and Law Enforcement on the referral of Ms. Karen Downin. I would ask Ms. Downin and/or Dr. Jacques to provide co-cure with a response, and to copy in the above listed congressional contacts. Once again, I cannot stress strongly enough. Please contact your healthcare providers; you may want to ask your healthcare providers to forward their contact information to these congressional offices for the purpose of a response.

    Ms. Sara Holbom, Caseworker
    The Honorable Susan Collins
    Portland, Me office:
    1 City Center
    Portland Maine, 04101
    207 780 3575

    Ms. Ann Goodridge, Caseworker
    The Honorable Thomas Allen
    Portland Maine office:
    234 Oxford Street
    Portland, ME 04101
    207 774 5019

    Ms. Brooke Sikora, Legislative Assistant
    The Honorable John McCain
    Washington, DC office:
    241 Russell Senate Office Bldg.
    United States Senate
    Washington D.C., Washington DC 20510
    Phone: (202) 224-2235
    Fax: (202) 228-2862

    In addition, Gail Kansky from the National CFIDS Foundation and Barbara Buchman from ILADS are also documenting these issues.

    To congressional staffers. A) At this juncture, it is imperative to alert patients and physicians who have used or who are using injectable Kutapressin to the potential health and safety issues, including but not limited to the expired batch lot. While at this juncture, there is no Kutapressin in the wholesale/distribution channel, there may still be a safety supply of kutpressin in the pharmacy channel and in the hands of patients. The most efficient method of obtaining accurate patient physician data would be to contact AmerisourceBergen (ABC), Cardinal Health (CAH) and McKesson (MCK), force them to release their product records, and work down the pharmacy and prescription benefit management (PBM) channels.
    B) I am forwarding contact information for a regional FDA official that I spoke with on Friday, August 1, 2003. He is looking into this matter. He may need to contact you for further information, and he is looking forward to working with you.

    C) Medication substitutions. Physicians need assistance.
    NOTE: My visiting pharmacist, a pharmacy manager at CVS pharmacy, will not call CVS corporate to force CVS corporate to notify patients and physicians using Kutapressin about the expiration date issue. Obviously, patients should notify their physicians. Please feel free to print this email and to bring it to your physician(s).
  2. cma331

    cma331 New Member

    Thank you for all that info on Kutapressin....I would be interested to see how many people reply that they are using it.......I have been on it for 4 years now.....I get it from a small private parmacy; who gets it from his supplier(?) I live in NJ; and it was not available for June-July....but i got my order last week.......My CFS/Fm specialist told us that it was alright to use the expired batch(?).......
    I too; along with my support group friends; have called Shwarz.....but get the run around.........
    Do you have it back in circulation in the state you live in?
    Both the bottle; and the box; i just received, have a 01/04 exp. date.......Would love to hear more about this' but don't always find this board.......My e mail is cma331@aol.com.....would love to hear from you......
  3. beckster

    beckster New Member

    thanks for the info. I have not yet used kutapressin but hope to try it soon--as I have a very bad viral load, especially in winter. If you see this could you please post what kind of things (symptoms, conditions) it has helped you with?

  4. annepat

    annepat New Member

    It is NEVER acceptable, under ANY circumstance to inject an EXPIRED medication. We have no idea when it was manufactured, how it was stored, or why manufacturing was ceased.

    The FDA and HHS have failed us.
  5. annepat

    annepat New Member

    I need some help with this. Please bump up.

    I need to have everyone who is on Kutapressin contact the congressional offices listed above.

  6. dove1

    dove1 New Member

    I am suffering a great deal without kutapressin. I read your post and am confused (it's me, not you.) Who do I write to help get Kutapressin back on the market? I will ask my local support group to help me in this letter writing campaign. Thanks for your clarification and ALL your hard work.
  7. annepat

    annepat New Member

    Write to Public citizen, they are the ralph Nader group, and they have agreed to help us. Copy your letter to Brooke Sikora at Senator John McCAin's Wash office and Ann Goodridge @ Congressman Tom Allen's office.

    Please put Kutapressin in the subject line.

    You can copy and paste staff email addresses from the post, public citizen has a website w/email contact info.

    ALSO-ongoing FDA investigation at Taylor. Please read other posts