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FDA Issues Alert About Cellcept - May Cause Fetal Malformations

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  • FDA Issues Alert About Cellcept - May Cause Fetal Malformations

    (Cellcept is currently under clinical trials as a treatment for severe IC. If you are taking cell cept or are in any of these studies, please visit the URL below and provide it to your doctors. This is VERY serious for women of childbearing age. - Jill )

    Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations,
    especially external ear and facial abnormalities including cleft lip and
    palate, and anomalies of the distal limbs, heart, esophagus, and kidney.
    Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk). Labeling changes include the following sections: BOXED WARNING, WARNINGS/Pregnancy and Pregnancy Exposure Prevention, PRECAUTIONS/Information for Patients, and ADVERSE REACTIONS/Postmarketing Experience.

    Within one week of beginning CellCept therapy, women of childbearing potential should have a negative serum or urine pregnancy test. In addition, women of childbearing potential (including pubertal girls and peri-menopausal woman) taking CellCept must receive contraceptive counseling and use effective contraception. Healthcare professionals and patients should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness. See the Dear Healthcare Professional Letter for additional recommendations for women of childbearing potential.

    Read the complete MedWatch 2007 Safety Summary including a link to the
    Dear Healthcare Professional Letter and revised prescribing information,
    at:

    http://www.fda.gov/medwatch/safety/2....htm#CellCept2
    Would you like to talk with someone about your IC struggles? The ICN now offers personal coaching sessions that include myself, Julie Beyer RD on the diet and Dr. Heather Howard on Sexuality. http://www.icnsales.com/icn-personal-coaching/

    Looking for books, magazines & reports on IC? Please visit the ICN Shop at: http://www.icnsales.com: Your ICN subscription & purchases in our shop support these message boards, chats and special events. BECOME AN ICN ANGEL TODAY!

    Please remember that the information on the ICN is provided with the understanding that ICN, its founder, staff, volunteers, and participants are not engaged in rendering medical or professional medical services. We cannot and do not give medical advice. Only your personal physician can do this for you.







  • #2
    I was offered this trial but didn't take it because it just was really feasible for me at this point and my hubby was scared to death of me doing it. Even though I don't want to have any more kids it is really scarey being of child bearing age that this is a side effect. This just confirms my oringial thoughts that this was not the right therapy for me.
    Christine



    I have been diagnoised for 6 1/2 years now. I have taken a long break from the ICN but really miss helping out my fellow IC patients and want to get back into posting.
    1st hydro 4/07 showed no visible signs of IC but tons of mast cells in all my biopsy samples which did prove IC.
    2nd hydro 4/13/09 showed dark purple glomerulations and I had a capacity of 450 cc's. This hydro proved that my IC had progressed.
    I have tried every oral medication as well as rescue instills and DMSO.

    I have been lucky enough to see Dr Hanno, the top IC specialist in PA who has told me due to the fact that I have not responded to any "standard" treatments that I have a severe, end stage case of IC with a horrible quality of life (didn't have to tell me that last part!)

    Proud wifey of Shane, mommy to Griffin, and step-mom to Logan and Gage
    Also proud mom to the best Bullmastiff on earth, Claus

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    • #3
      i am asking here because the crowd seems knowledgeable to me. so, does everyone progress to the end stage of this disease, meaning that the bladder comes out or that intense chronic pain is a sure thing. or if the diet is managed well enough can i just go on like this, miserable some of the time, but not disabled or anything and still able to work, until the end of my days. i know no one can say for sure and some people supposedly spontaneously resolve, but what are the odds of progression. many thanks

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      • #4
        I really don't know. Upon reading many of the threads on this site it seems I am unusual because my IC continues to worsen and my Doctor's nurse said this as well. I do have my OK days and really bad days. Medication and diet sure help me.

        However, if you read most of the information from people posting they usually don't get worse. And, many of them get better or go into full remission so have hope.

        Have you been able to buy the "Book" and articles available at the ICN store? They have been a lifesaver for me.
        BBB - Diagnosed with Moderate/Severe IC (age 12), Severe PFD and V V (age 21), IBS (from birth) & Gastroparesis (age 42)

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        • #5
          Bumped from Cell Cept

          Hi:

          Just so you know some sites are bumping woman of childbearing potential. I was bumped off drug on Friday, and still need to continue through the study as if I was on drug. It is a long commute for me about 100 miles w/ gas at 3.00 a gallon here in MI. I don't think this is fair. I am not sexually active, have not potential to. oh well. this is the luck I have.

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          • #6
            cellcept study has resumed as of last week

            Hi:

            Well, I had my first cell cept post visit. In one week my voids decreased from 15 to 5. This may not be typical. Noticing a subtle decrease in pain. My doctor is still prescribing pain meds, but he knows I have some other things going on as well like a torn rotator cuff, arthritis, and tendonitis. My new primary would prescribe the pain meds but not the cell cept . So it is like a one stop shopping for now. I guess the study is lasting longer as well about 4 weeks. I am one of those who got taken out of the trial and now it is being prescribed out of my drs private practice. He is monitoring me every month blood work and so forth. For those who have the wonderful insurance I have where you have to pay out than get reimbursed, I found out I can fill half the script and than get the other half when I need it. Not such a big amount.

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            • #7
              Originally posted by ejovan View Post
              i am asking here because the crowd seems knowledgeable to me. so, does everyone progress to the end stage of this disease, meaning that the bladder comes out or that intense chronic pain is a sure thing. or if the diet is managed well enough can i just go on like this, miserable some of the time, but not disabled or anything and still able to work, until the end of my days. i know no one can say for sure and some people supposedly spontaneously resolve, but what are the odds of progression. many thanks
              Everybody patient is different. Some ICer have urgency and frequency and " minimal pain" Some ICers have pain 24-7. I have a friend also with IC and she has had IC for 4 years. I feel so bad for her. She is in pain everyday and pretty much housebound. She is going to have sacral neuro implant done here in one week. I survived IC for 20 years of working full time as a staff recovery room RN. This last 1-2 years the pain was constant and work I could not do it physically anymore. For me IC was progressive. I planned on working till I was 55. My uro said the day would come where I would not be able to work anymore. My bladder capacity 175cc under anesthesia. Bladder is not only small but scarred and fibrosed.

              Then you have some patient who are able to manage IC with diet and meds and still have" Good quality of life" and work full time .

              I certaintly would give anything to go back to work in nursing even part time.
              I would gladly return to work if it was the right job. My uro and family MD say no and I was declared disabled on 9/11/07 my SS was approved on first attempt and with no lawyer.

              Vicky

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              • #8
                As far as I know, once they find a decent treatment, most people stop progressing.

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                • #9
                  Hmm. I have had a hysterectomy, so if the Elmiron ever stops working, I should be allowed to try this other medicine.

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                  • #10
                    cell cept

                    hi:
                    for me it has been a godsend. as i said before my doc knows i have other pain issues going on so he is still willing to prescribe oxycontin. right know i am having so many problems with my shoulder i want to cut it off. and i may have osteoporosis at 40. lucky me. bone scan results this week need prayers..

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                    • #11
                      I have arthritis from h*ll, myself. I hope your scan results show decent bone density! *knocks on wood*

                      I'm 39. Feel much older some days. *sigh*

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                      • #12
                        bone density results show signs of osteosporisis

                        Well I kind of knew this was coming. Everyone on my mom's side has it. I have a -1.7 in my spine and -1.2 in my left femur.

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