cellcept and birth defects

[mima]

I am scheduled to donate to my husband on dec 5th.  All throughout the evaluation process we have spoken with the doctors about our interest in having more children after the surgery.  I even asked specifically if any of the medications that my husband will need to be taking can cause issues with fertility or reproductive development.  I asked if it was necessary to freeze sperm, and they all said no, it should be fine, that we should just wait 6-12 months after surgery for me to get pregnant.  So we were fine with that.  Last week we met with the in-patient nurse who told us a lot about the medication protocol he will likely be on.  One of the medications is cellcept, and he made it very clear that we should make sure not to get pregnant while my husband is taking it, and that he will need to take it for 2 years at least before they will be willing to switch him to something else (I can't remember the alternative, but the nurse said it was a drug that has been around long before cellcept came around and it is not as good as cellcept).  I am going to call the doctor on monday to try to get some more answers.  But in the meantime, do any of you know about other alternatives to cellcept?
Has anyone else gotten pregnant after your husband has had a transplant?  What medications where they on? Did you save sperm prior to the transplant?
I just find this frustrating because during the whole evaluation process they drill you with so many questions, and I wonder if they were even really listening to the answers.
Thanks!

[okarol]

That's very confusing to me. I would ask the nurse to provide you with more information. I have never heard of a man being warned about CellCept use. We were told that should Jenna choose to get pregnant she would have to switch to another immunosuppressant prior to conception to avoid birth defects which can include deformities of the head, neck and shoulders.

This warning is directly from CellCept's website: http://www.cellceptforliving.com/

If you are a woman of childbearing age, you must use highly effective (2 methods) contraception 4 weeks prior to starting CellCept therapy, and continue contraception until 6 weeks after stopping CellCept treatment, unless abstinence is the chosen method. A patient who is planning a pregnancy should not use CellCept unless she cannot be successfully treated with other immunosuppressant drugs. If you are considering pregnancy, be sure to talk to your doctor.

There's also this recent news story. Again, it only refers to women:

Roche's CellCept raises birth defect risks: FDA

Mon Oct 29, 2007 10:00pm GMT

WASHINGTON (Reuters) - The Food and Drug Administration said on Monday the Roche Holding AG organ rejection drug, CellCept, boosts the risk of pregnancy loss in the first trimester and also the risk of congenital malformations.

The FDA said it added a new boxed warning to the drug's label about the increased fetal risk of ear and facial deformities and problems in limbs, the heart and other organs. Data collected from a national registry led to the new warning, the FDA said.

CellCept should not be given until a negative pregnancy test is confirmed within one week prior to therapy, the FDA said. The drug may reduce the effectiveness of birth control pills, the FDA said.

CellCept is used to help prevent kidney, liver and heart transplant rejection.

The FDA in its warning cited a review of postmarketing data from 1995 to 2007 that found among 77 women exposed to the drug, 25 had a spontaneous abortion and 14 had a deformed infant or fetus.

Because dangerous side effects are reported voluntarily to the FDA, it is difficult to determine how common the adverse outcomes are, the FDA said.

Prehuman studies of the drug did find some signs of fetal defects, the agency said.

http://uk.reuters.com/article/healthNews/idUKN2920254920071029?feedType=RSS&feedName=healthNews

[stauffenberg]

The usual drug which is substituted for Cellcept, and one that has been around for a long time, is Azathioprine.  Unfortunately this also has been shown to reduce sperm count slightly and diminish testicle size, as well as to cause mutations in the offspring of males taking the drug -- at least in laboratory animals.  Perhaps when the time comes for switching off of Cellcept, you can ask the nephrologist to try to come up with some alternative to the usual trade-off between Cellcept and Azathioprine.  There is also always the possibility of adoption which you might want to consider in any case if your husband's renal failure was due to inherited factors.

[lola]

My husband was 22 when he had his transplant we Were told there was a chance he may not be able to have kids but we figured we would cross that road when we got there he was on Azathioprine. We have 3 kids 10, 8 & 5 and we had no problems at all, but his one brother and his wife have not been able to have kids due to him having a low sperm count and now they have given up because of there ages. I would definitely ask more ?'s and maybe freeze some swimmers b-4 just to be safe. Good luck