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FDA Investigates Transplants Drugs' Risk

Regulators are exploring whether organ transplant drugs made by Roche and Novartis increase the risk of an often-fatal neurological disease. The FDA said it had identified 16 cases of patients developing the rare neurological ailment while taking Roch's drug CellCept, which is used to avoid rejection in organ transplant patients. Roche alerted regulators to the issue last November. The FDA is looking into similar risks with Myfortic. The article goes onto say it will take about 2 months to review the reports and approve new labeling for the medication. Until then, regulators advise doctors and patients to watch for symptoms of neurological problems. The disease attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination and memory loss. Patients that survive are often permanently disabled. Roche has confirmed 10 cases of the disease in CellCept patients. The drug has been used by an estimated 500,000 patients worldwide. Problems have been reported in kidney, heart and lung transplant patients.
16 Responses
Avatar universal
Hi Elaine,
              Information, information...this keeps me on my toes! But I love doing this for all the people that I love!   ~Kande
Avatar universal
I took CellCept for a while - maybe 6 months - and then stopped it a few years ago. I haven't noticed anything unusual - yet. Mike
458494 tn?1217171679
Hello, It's me Sherri Richard is taking 1000 mg of CellCept a day we started Ribavirin
today any news are something to watch for we do the first shot of the Pegayas tonight
need lots of info.
thanks for all you do Sherri.
Avatar universal
O.K., I need child24angel, myown, Dan, mikesimon, and anyone else that can help Richard & Sherri. Thanks everyone :o)  Love all of you! ~Kande
Avatar universal
hi Kande,
I don't know anything about CellCept - mikesimon would be the one. I just walked thru the door - starving to death - gonna eat lunch - maybe seeya later......


Good luck Richard!

Avatar universal
O.K., sweetie pie. "Thanks anyway." Glad you are here today!!!  :o)  ~Kande
Avatar universal
Hey Girl, Yes you will get your flower! Shame on you, haha! I'am leaving this one up to the experts, since I didn't have Hep. C. I still have my flower...silly girl. Love ya! Say "Hi" to Nick for me.  :o)  ~Kande   ((((HUGS & Kande KISSES))))
Avatar universal
I cannot think of anything that you should do differently. I would have to look back to see when I took CellCept and whether I was treating at the time. I suspect that I was treating because I treated for quite a long time before becoming undetectable. If I recall correctly,  I generally took my morning meds around 7:30 am and then a few hours later - maybe 10 am - I did my injection. If there were any precautions I didn't know about them. I only know that I spaced my meds and shots a few hours apart. I took CellCept with low dose Prograf by the way. But, I have taken almost every AR drug with the exception of Cyclopsorin at one time or another.
I wish you the best of luck. Mike
458494 tn?1217171679
Thank you I gave Richard his pills one hour apart then his shot before bed 11pm so far so good made it no problems.
Sherri&Richard
Avatar universal
You just reminded me that I too did my shot early when I started treatment. I had forgotten all about that. I treated 3 times - 1 year, 1 year and 73 weeks so I do forget things about treating. I honestly forgot all about my evening shots. I am sure that Karen remembers everything though. I believe it was during my second treatment that I did the shot in the mornings to get it over with early in the day. I did the evening shots before Pegylated interferon was available and I was doing three shots per week of regular interferon. I hope Richard is feeling as well as possible and that his spirits are high. And, I wish you both good luck and good health. Mike
Avatar universal
The sentence "You just reminded me that I too did my shot early when I started treatment" should have read ".....did my shot in the evening when I started treatment". I apologize for the confusion. Mike
458494 tn?1217171679
Richard started treatment monday watching him close he is not bad but feeling it just the same feeling sick for another year has him down this is the scary part.  I will try to
keep you all informed but thank you for thinking of us god bless
Richard&Sherri
Avatar universal
You both are in my prayers. Love to both of you  :o)
Avatar universal
Hi Mike, I remember last year BThompson brought up something negative about Cellcept.  I asked my Hepatologist about it and he said when you complete tx stop taking it.  I'll look up the thread in the Hep forum and see if I can post it tomorrow.  

kcmike
Avatar universal
I haven't taken it in quite a while but I seem to recall some issues with it. I cannot remember what the problems were except that it is associated with pregnancy loss. I have the article saved. Here is that link:
CellCept Linked to Pregnancy Loss, Congenital Malformations
http://www.medscape.com/viewarticle/565075?sssdmh=dm1.313967&src=nldne

Mike
Avatar universal
A new article in my inbox today.

Transplant Drug Linked to Risk for Fetal Harm
Yael Waknine

See: http://www.medscape.com/viewarticle/574718?sssdmh=dm1.353150&src=nldne
.
May 19, 2008 — A strong warning regarding the risk for first-trimester miscarriages and birth defects has been added to the safety labeling for mycophenolate mofetil (CellCept, Hoffman-LaRoche, Inc) and its metabolite, mycophenolic acid (Myfortic, Novartis Pharmaceuticals, Inc), the US Food and Drug Administration (FDA) announced on Friday.

Serious congenital anomalies, including microtia and cleft lip/palate have been reported in women who used mycophenolate mofetil (MMF) during the first trimester or until detection of pregnancy.

Although primarily reported in patients receiving organ-rejection prophylactic therapy, these events also occurred in patients receiving MMF for off-label indications, such as systemic lupus erythematosus, and erythema multiforme. In light of this positive evidence for fetal risk, the pregnancy category for MMF and mycophenolic acid (MPA) was changed to "D" in November 2007.

Women of childbearing potential considering treatment with MMF/MPA should be warned of the risk for fetal harm and should be made aware of available contraceptive options, according to an alert issued by MedWatch, the FDA's safety information and adverse-event reporting program.

Patients should be advised that mycophenolate sodium reduces estrogen/progestin blood levels and could theoretically reduce the efficacy of oral contraceptive pills.

Unless choosing abstinence as a method of birth control, women receiving MMF/MPA are therefore required to use 2 methods of contraception starting 4 weeks before initiation of therapy, and should have a negative serum or urine pregnancy test during the week before taking the first dose. Contraceptive use should continue during treatment and for 6 weeks posttherapy.

The FDA emphasizes that contraceptive therapy should be initiated concomitantly with MMF/MPA in women who begin treatment in a hospital setting after transplant surgery.

Mycophenolate mofetil is indicated to prevent rejection of allogenic renal, cardiac, or hepatic transplants. Mycophenolic acid is indicated for the prophylaxis of organ rejection in patients receiving allogenic renal transplant.

Adverse events related to use of MMF or MPA should be reported to the FDA's MedWatch reporting program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), online (http://www.fda.gov/medwatch) , or by mail (5600 Fishers Lane, Rockville, MD 20852-9787).

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